Vitiligo
Conditions
Keywords
Vitiligo, depigmenting disorder, topical JAK inhibitor
Brief summary
The purpose of this study will be to examine the efficacy, safety, and tolerability of ruxolitinib cream in subjects with vitiligo.
Interventions
DRUGRuxolitinib cream
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
DRUGVehicle cream
Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.
Sponsors
Incyte Corporation
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double Blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of vitiligo. * Vitiligo with depigmented areas including: * at least 0.5% of the total body surface area (BSA) on the face (0.5% BSA is approximately equal to the area of the participant's palm \[without digits\]) AND * at least 3% of the total BSA on nonfacial areas (3% BSA is approximately equal to the area of 3 of the participant's handprints \[palm plus 5 digits\]). * Participants who agree to discontinue all agents used to treat vitiligo from screening through the final follow-up visit. Over-the-counter preparations deemed acceptable by the investigator and camouflage makeups are permitted.
Exclusion criteria
* Conditions at baseline that would interfere with evaluation of vitiligo. * Participants who are receiving any kind of phototherapy, including tanning beds. * Participants with other dermatologic disease besides vitiligo whose presence or treatments could complicate the assessment of repigmentation. * Participants who have used skin bleaching treatments for past treatment of vitiligo or other pigmented areas. * Participants who have received any of the following treatments within the minimum specified timeframes. * Use of any biologic, investigational, or experimental therapy or procedure for vitiligo within 12 weeks or 5 half-lives (whichever is longer) of screening. * Use of laser or light-based vitiligo treatments, including tanning beds, within 8 weeks of screening. * Use of immunomodulating oral or systemic medications (eg, corticosteroids, methotrexate, cyclosporine) or topical treatments that may affect vitiligo (eg, corticosteroids, tacrolimus/pimecrolimus, retinoids) within 4 weeks of screening. * Use of any prior and concomitant therapy not listed above that may interfere with the objective of the study as per discretion of the investigator, including drugs that cause photosensitivity or skin pigmentation (eg, antibiotics such as tetracyclines, antifungals) within 8 weeks of screening. * Participants with a clinically significant abnormal thyroid-stimulating hormone or free T4 at screening. * Participants with protocol-defined cytopenias at screening * Participants with severely impaired liver function. * Participants with impaired renal function. * Participants taking potent systemic cytochrome P450 3A4 inhibitors or fluconazole within 2 weeks or 5 half-lives, whichever is longer, before the baseline visit. * Participants who have previously received JAK inhibitor therapy, systemic or topical.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Treated With Ruxolitinib Cream Who Achieved a ≥ 50% Improvement From Baseline in Facial Assessment of the Vitiligo Area and Severity Index Score (F-VASI50) Compared With Participants Treated With Vehicle at Week 24 | Baseline; Week 24 | An F-VASI50 responder achieved at least 50% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of body surface area \[BSA\]) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved a ≥ 50% Improvement From Baseline in Full Body Assessment of Vitiligo Area and Severity Index (T-VASI) at Week 52 | Baseline; Week 52 | T-VASI was measured by the percentage of vitiligo involvement from all body regions (percentage of BSA; assessed by the Investigator) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was derived by multiplying the vitiligo involvement values by the percentage of affected skin for each body site and summing all values (possible range: 0-100; lower scores indicate increased improvement). |
| Dose Response on Percentage Change From Baseline in F-VASI | up to 156 weeks | — |
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Grade 3 or Higher TEAE up to Week 24 | up to 24 weeks | An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. A TEAE was an AE reported for the first time or the worsening of a pre-existing event after first application of study drug. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grades 1 through 4. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent intervention indicated. |
| Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE up to Week 52 | up to 52 weeks | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. A TEAE was an AE reported for the first time or the worsening of a pre-existing event after first application of study drug. The severity of AEs was assessed using CTCAE v4.03 Grades 1 through 4. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent intervention indicated. |
| Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE From Week 24 to Week 52 | Week 24 to Week 52 | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. A TEAE was an AE reported for the first time or the worsening of a pre-existing event after first application of study drug. The severity of AEs was assessed using CTCAE v4.03 Grades 1 through 4. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent intervention indicated. |
| Number of Participants Who Applied Ruxolitinib 1.5% Cream BID Throughout Study Participation With Any TEAE and Any Grade 3 or Higher TEAE | up to Week 156 | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. A TEAE was an AE reported for the first time or the worsening of a pre-existing event after first application of study drug. The severity of AEs was assessed using CTCAE v4.03 Grades 1 through 4. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent intervention indicated. |
| Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE From Week 52 to Week 156 | Week 52 to Week 156 | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. A TEAE was an AE reported for the first time or the worsening of a pre-existing event after first application of study drug. The severity of AEs was assessed using CTCAE v4.03 Grades 1 through 4. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent intervention indicated. |
| Mean Change From Baseline in F-VASI Score at Week 24 | Baseline; Week 24 | F-VASI was measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Mean Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Baseline; Weeks 52, 104, and 156 | F-VASI was measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Percentage Change From Baseline in F-VASI Score at Week 24 | Baseline; Week 24 | F-VASI was measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement). Percentage change = (\[post-Baseline value minus Baseline value\]/Baseline value) X 100. |
| Percentage Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Baseline; Weeks 52, 104, and 156 | F-VASI was measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement). Percentage change = (\[post-Baseline value minus Baseline value\]/Baseline value) X 100. |
| Percentage of Participants Who Achieved an F-VASI50 at Weeks 52, 104, and 156 | Baseline; Weeks 52, 104, and 156 | An F-VASI50 responder achieved at least 50% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement). |
| Percentage Change From Baseline in F-BSA Repigmentation at Week 24 | Baseline; Week 24 | F-BSA involvement was the proportion of the facial body surface area with vitiligo. The area Face was defined as including the area on the forehead to the original hairline, on the cheek to the jawline vertically and laterally from the corner of the mouth to the tragus. The area Face did not include the surface area of the lips, scalp, ears, or neck, but included the nose and eyelids. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Percentage change = (\[post-Baseline value minus Baseline value\]/Baseline value) X 100. |
| Percentage Change From Baseline in F-BSA Repigmentation at Weeks 52, 104, and 156 | Baseline; Weeks 52, 104, and 156 | F-BSA involvement was the proportion of the facial body surface area with vitiligo. The area Face was defined as including the area on the forehead to the original hairline, on the cheek to the jawline vertically and laterally from the corner of the mouth to the tragus. The area Face did not include the surface area of the lips, scalp, ears, or neck, but included the nose and eyelids. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Percentage change = (\[post-Baseline value minus Baseline value\]/Baseline value) X 100. |
| Percentage Change From Baseline in T-BSA Repigmentation at Week 24 | Baseline; Week 24 | T-BSA involvement was the proportion of the body surface area with vitiligo. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Percentage change = (\[post-Baseline value minus Baseline value\]/Baseline value) X 100. |
| Percentage Change From Baseline in T-BSA Repigmentation at Weeks 52, 104, and 156 | Baseline; Weeks 52, 104, and 156 | T-BSA involvement was the proportion of the body surface area with vitiligo. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Percentage change = (\[post-Baseline value minus Baseline value\]/Baseline value) X 100. |
| Mean Change From Baseline in T-VASI Score at Week 24 | Baseline; Week 24 | T-VASI was calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement). Change from Baseline (BL) was calculated as the post-BL value minus the BL value. |
| Mean Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Baseline; Weeks 52, 104, and 156 | T-VASI was calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement). Change from BL was calculated as the post-BL value minus the BL value. |
| Percentage Change From Baseline in T-VASI Score at Week 24 | Baseline; Week 24 | T-VASI was calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement). |
| Percentage Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Baseline; Weeks 52, 104, and 156 | T-VASI was calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement). |
| Mean Change From Baseline in Vitiligo European Task Force (VETF) Scale Scores at Week 24: Total Spreading | Baseline; Week 24 | The VETF-proposed system combines analysis of extent (0%-100% BSA), stage of disease (staging), and disease progression (spreading); each component is evaluated and reported independently. Staging is based on cutaneous and hair pigmentation in vitiligo patches. Disease is staged 0 to 4 on the largest macule in each of 5 body regions, except hands and feet, which are assessed separately and globally as 1 unique area. Stage 0=normal pigmentation, Stage 1=incomplete pigmentation, Stage 2=complete depigmentation (a few white hairs do not change stage), Stage 3=partial hair whitening (\<30%), Stage 4=complete hair whitening; total score of 0 (less severe disease) to 20 (more severe disease). Disease progression is based on assessing the largest patch in each of 5 body areas: -1=regressive vitiligo (ongoing subclinical repigmentation), 0=similar limits, 1=progressive vitiligo (ongoing subclinical depigmentation); total score of -5 (improving disease) to +5 (more severe disease spread). |
| Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Spreading | Baseline; Weeks 52 and 104 | The VETF-proposed system combines analysis of extent (0%-100% BSA), stage of disease (staging), and disease progression (spreading); each component is evaluated and reported independently. Staging is based on cutaneous and hair pigmentation in vitiligo patches. Disease is staged 0 to 4 on the largest macule in each of 5 body regions, except hands and feet, which are assessed separately and globally as 1 unique area. Stage 0=normal pigmentation, Stage 1=incomplete pigmentation, Stage 2=complete depigmentation (a few white hairs do not change stage), Stage 3=partial hair whitening (\<30%), Stage 4=complete hair whitening; total score of 0 (less severe disease) to 20 (more severe disease). Disease progression is based on assessing the largest patch in each of 5 body areas: -1=regressive vitiligo (ongoing subclinical repigmentation), 0=similar limits, 1=progressive vitiligo (ongoing subclinical depigmentation); total score of -5 (improving disease) to +5 (more severe disease spread). |
| Mean Change From Baseline in VETF Scale Scores at Week 24: Total Percentage Area | Baseline; Week 24 | The VETF-proposed system combines analysis of extent (0%-100% BSA), stage of disease (staging), and disease progression (spreading); each component is evaluated and reported independently. Staging is based on cutaneous and hair pigmentation in vitiligo patches. Disease is staged 0 to 4 on the largest macule in each of 5 body regions, except hands and feet, which are assessed separately and globally as 1 unique area. Stage 0=normal pigmentation, Stage 1=incomplete pigmentation, Stage 2=complete depigmentation (a few white hairs do not change stage), Stage 3=partial hair whitening (\<30%), Stage 4=complete hair whitening; total score of 0 (less severe disease) to 20 (more severe disease). Disease progression is based on assessing the largest patch in each of 5 body areas: -1=regressive vitiligo (ongoing subclinical repigmentation), 0=similar limits, 1=progressive vitiligo (ongoing subclinical depigmentation); total score of -5 (improving disease) to +5 (more severe disease spread). |
| Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Percentage Area | Baseline; Weeks 52 and 104 | The VETF-proposed system combines analysis of extent (0%-100% BSA), stage of disease (staging), and disease progression (spreading); each component is evaluated and reported independently. Staging is based on cutaneous and hair pigmentation in vitiligo patches. Disease is staged 0 to 4 on the largest macule in each of 5 body regions, except hands and feet, which are assessed separately and globally as 1 unique area. Stage 0=normal pigmentation, Stage 1=incomplete pigmentation, Stage 2=complete depigmentation (a few white hairs do not change stage), Stage 3=partial hair whitening (\<30%), Stage 4=complete hair whitening; total score of 0 (less severe disease) to 20 (more severe disease). Disease progression is based on assessing the largest patch in each of 5 body areas: -1=regressive vitiligo (ongoing subclinical repigmentation), 0=similar limits, 1=progressive vitiligo (ongoing subclinical depigmentation); total score of -5 (improving disease) to +5 (more severe disease spread). |
| Percentage Change From Baseline in VETF Scale Scores at Week 24: Total Percentage Area | Baseline; Week 24 | The VETF-proposed system combines analysis of extent (0%-100% BSA), stage of disease (staging), and disease progression (spreading); each component is evaluated and reported independently. Staging is based on cutaneous and hair pigmentation in vitiligo patches. Disease is staged 0 to 4 on the largest macule in each of 5 body regions, except hands and feet, which are assessed separately and globally as 1 unique area. Stage 0=normal pigmentation, Stage 1=incomplete pigmentation, Stage 2=complete depigmentation (a few white hairs do not change stage), Stage 3=partial hair whitening (\<30%), Stage 4=complete hair whitening; total score of 0 (less severe disease) to 20 (more severe disease). Disease progression is based on assessing the largest patch in each of 5 body areas: -1=regressive vitiligo (ongoing subclinical repigmentation), 0=similar limits, 1=progressive vitiligo (ongoing subclinical depigmentation); total score of -5 (improving disease) to +5 (more severe disease spread). |
| Percentage Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Percentage Area | Baseline; Weeks 52 and 104 | The VETF-proposed system combines analysis of extent (0%-100% BSA), stage of disease (staging), and disease progression (spreading); each component is evaluated and reported independently. Staging is based on cutaneous and hair pigmentation in vitiligo patches. Disease is staged 0 to 4 on the largest macule in each of 5 body regions, except hands and feet, which are assessed separately and globally as 1 unique area. Stage 0=normal pigmentation, Stage 1=incomplete pigmentation, Stage 2=complete depigmentation (a few white hairs do not change stage), Stage 3=partial hair whitening (\<30%), Stage 4=complete hair whitening; total score of 0 (less severe disease) to 20 (more severe disease). Disease progression is based on assessing the largest patch in each of 5 body areas: -1=regressive vitiligo (ongoing subclinical repigmentation), 0=similar limits, 1=progressive vitiligo (ongoing subclinical depigmentation); total score of -5 (improving disease) to +5 (more severe disease spread). |
| Mean Change From Baseline in VETF Scale Scores at Week 24: Total Staging | Baseline; Week 24 | The VETF-proposed system combines analysis of extent (0%-100% BSA), stage of disease (staging), and disease progression (spreading); each component is evaluated and reported independently. Staging is based on cutaneous and hair pigmentation in vitiligo patches. Disease is staged 0 to 4 on the largest macule in each of 5 body regions, except hands and feet, which are assessed separately and globally as 1 unique area. Stage 0=normal pigmentation, Stage 1=incomplete pigmentation, Stage 2=complete depigmentation (a few white hairs do not change stage), Stage 3=partial hair whitening (\<30%), Stage 4=complete hair whitening; total score of 0 (less severe disease) to 20 (more severe disease). Disease progression is based on assessing the largest patch in each of 5 body areas: -1=regressive vitiligo (ongoing subclinical repigmentation), 0=similar limits, 1=progressive vitiligo (ongoing subclinical depigmentation); total score of -5 (improving disease) to +5 (more severe disease spread). |
| Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Staging | Baseline; Weeks 52 and 104 | The VETF-proposed system combines analysis of extent (0%-100% BSA), stage of disease (staging), and disease progression (spreading); each component is evaluated and reported independently. Staging is based on cutaneous and hair pigmentation in vitiligo patches. Disease is staged 0 to 4 on the largest macule in each of 5 body regions, except hands and feet, which are assessed separately and globally as 1 unique area. Stage 0=normal pigmentation, Stage 1=incomplete pigmentation, Stage 2=complete depigmentation (a few white hairs do not change stage), Stage 3=partial hair whitening (\<30%), Stage 4=complete hair whitening; total score of 0 (less severe disease) to 20 (more severe disease). Disease progression is based on assessing the largest patch in each of 5 body areas: -1=regressive vitiligo (ongoing subclinical repigmentation), 0=similar limits, 1=progressive vitiligo (ongoing subclinical depigmentation); total score of -5 (improving disease) to +5 (more severe disease spread). |
| Percentage Change From Baseline in VETF Scale Scores at Week 24: Total Staging | Baseline; Week 24 | The VETF-proposed system combines analysis of extent (0%-100% BSA), stage of disease (staging), and disease progression (spreading); each component is evaluated and reported independently. Staging is based on cutaneous and hair pigmentation in vitiligo patches. Disease is staged 0 to 4 on the largest macule in each of 5 body regions, except hands and feet, which are assessed separately and globally as 1 unique area. Stage 0=normal pigmentation, Stage 1=incomplete pigmentation, Stage 2=complete depigmentation (a few white hairs do not change stage), Stage 3=partial hair whitening (\<30%), Stage 4=complete hair whitening; total score of 0 (less severe disease) to 20 (more severe disease). Disease progression is based on assessing the largest patch in each of 5 body areas: -1=regressive vitiligo (ongoing subclinical repigmentation), 0=similar limits, 1=progressive vitiligo (ongoing subclinical depigmentation); total score of -5 (improving disease) to +5 (more severe disease spread). |
| Percentage Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Staging | Baseline; Weeks 52 and 104 | The VETF-proposed system combines analysis of extent (0%-100% BSA), stage of disease (staging), and disease progression (spreading); each component is evaluated and reported independently. Staging is based on cutaneous and hair pigmentation in vitiligo patches. Disease is staged 0 to 4 on the largest macule in each of 5 body regions, except hands and feet, which are assessed separately and globally as 1 unique area. Stage 0=normal pigmentation, Stage 1=incomplete pigmentation, Stage 2=complete depigmentation (a few white hairs do not change stage), Stage 3=partial hair whitening (\<30%), Stage 4=complete hair whitening; total score of 0 (less severe disease) to 20 (more severe disease). Disease progression is based on assessing the largest patch in each of 5 body areas: -1=regressive vitiligo (ongoing subclinical repigmentation), 0=similar limits, 1=progressive vitiligo (ongoing subclinical depigmentation); total score of -5 (improving disease) to +5 (more severe disease spread). |
| Percentage of Participants in Each Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) Category at Week 24 | Week 24 | The severity of vitiligo was assessed by the physician using the PhGVA, which has a 5-point scale. 0=clear, no signs of vitiligo; 1=almost clear, only specks of depigmentation present; 2=mild disease, pigmented and depigmented areas are equal; 3=moderate disease, more or complete depigmentation (may include \< 30% hair whitening); 4=severe disease, complete depigmentation plus \> 30% hair whitening. |
| Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Weeks 52, 104, and 156 | The severity of vitiligo was assessed by the physician using the PhGVA, which has a 5-point scale. 0=clear, no signs of vitiligo; 1=almost clear, only specks of depigmentation present; 2=mild disease, pigmented and depigmented areas are equal; 3=moderate disease, more or complete depigmentation (may include \< 30% hair whitening); 4=severe disease, complete depigmentation plus \> 30% hair whitening. |
| Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Week 24 | Week 24 | The severity of vitiligo was assessed by the physician using the PhGVA, which has a 5-point scale. 0=clear, no signs of vitiligo; 1=almost clear, only specks of depigmentation present; 2=mild disease, pigmented and depigmented areas are equal; 3=moderate disease, more or complete depigmentation (may include \< 30% hair whitening); 4=severe disease, complete depigmentation plus \> 30% hair whitening. |
| Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Weeks 52, 104, and 156 | The severity of vitiligo was assessed by the physician using the PhGVA, which has a 5-point scale. 0=clear, no signs of vitiligo; 1=almost clear, only specks of depigmentation present; 2=mild disease, pigmented and depigmented areas are equal; 3=moderate disease, more or complete depigmentation (may include \< 30% hair whitening); 4=severe disease, complete depigmentation plus \> 30% hair whitening. |
| Percentage of Participants in Each Facial Assessment of the Patient's Global Vitiligo Assessment (F-PaGVA) Category at Week 24 | Week 24 | The severity of vitiligo was assessed by the participant using the PaGVA, which has a 5-point scale. The participant was asked the following: How severe is your vitiligo on your face (or total body) with respect to the area covered by white skin? Responses: 0=no white patches (no vitiligo); 1=mild; 2=moderate; 3=severe; 4=very severe. |
| Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Weeks 52, 104, and 156 | The severity of vitiligo was assessed by the participant using the PaGVA, which has a 5-point scale. The participant was asked the following: How severe is your vitiligo on your face (or total body) with respect to the area covered by white skin? Responses: 0=no white patches (no vitiligo); 1=mild; 2=moderate; 3=severe; 4=very severe. |
| Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Week 24 | Week 24 | The severity of vitiligo was assessed by the participant using the PaGVA, which has a 5-point scale. The participant was asked the following: How severe is your vitiligo on your face (or total body) with respect to the area covered by white skin? Responses: 0=no white patches (no vitiligo); 1=mild; 2=moderate; 3=severe; 4=very severe. |
| Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Weeks 52, 104, and 156 | The severity of vitiligo was assessed by the participant using the PaGVA, which has a 5-point scale. The participant was asked the following: How severe is your vitiligo on your face (or total body) with respect to the area covered by white skin? Responses: 0=no white patches (no vitiligo); 1=mild; 2=moderate; 3=severe; 4=very severe. |
| Percentage of Participants in Each Patient Global Impression of Change for Vitiligo (PaGIC-V) Category at Week 24 | Baseline; Week 24 | The PaGIC-V is an assessment of improvement by the participant. It is a 7-point scale comparing the vitiligo areas at Baseline with the participant's treated areas of vitiligo at the study visit. The participant answered the following: Since the start of the treatment you've received in this study, your vitiligo in areas treated with the study drug is: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; and 7, very much worse. |
| Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Baseline; Weeks 52, 104, and 156 | The PaGIC-V is an assessment of improvement by the participant. It is a 7-point scale comparing the vitiligo areas at Baseline with the participant's treated areas of vitiligo at the study visit. The participant answered the following: Since the start of the treatment you've received in this study, your vitiligo in areas treated with the study drug is: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; and 7, very much worse. |
| Percentage of Participants Who Report a PaGIC-V Score of Very Much Improved or Much Improved at Week 24 | Baseline; Week 24 | The PaGIC-V is an assessment of improvement by the participant. It is a 7-point scale comparing the vitiligo areas at Baseline with the participant's treated areas of vitiligo at the study visit. The participant answered the following: Since the start of the treatment you've received in this study, your vitiligo in areas treated with the study drug is: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; and 7, very much worse. |
| Percentage of Participants Who Achieved a Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) of Clear or Almost Clear | Week 24 | The severity of vitiligo was assessed by the physician using the PhGVA, which has a 5-point scale. 0=clear, no signs of vitiligo; 1=almost clear, only specks of depigmentation present; 2=mild disease, pigmented and depigmented areas are equal; 3=moderate disease, more or complete depigmentation (may include \< 30% hair whitening); 4=severe disease, complete depigmentation plus \> 30% hair whitening. |
| Time to Achieve an F-VASI50: Number of Days From the Date of the First Application in the Double-Blind Period to the Date of the First Evaluation at Which the Participant Met the F-VASI50 Score | up to 52 weeks | An F-VASI50 responder achieved at least 50% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement). |
| Time to Achieve a T-VASI50: Number of Days From the Date of the First Application in the Double-Blind Period to the Date of the First Evaluation at Which the Participant Met the T-VASI50 Score | up to 52 weeks | A T-VASI50 responder achieved at least 50% improvement from Baseline in T-VASI. T-VASI was measured by the percentage of vitiligo involvement from all body regions (percentage of BSA; assessed by the Investigator) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was derived by multiplying the vitiligo involvement values by the percentage of affected skin for each body site and summing all values (possible range: 0-100; lower scores indicate increased improvement). |
| Time to Achieve an F-PhGVA of Clear or Almost Clear | up to 52 weeks | The severity of vitiligo was assessed by the physician using the PhGVA, which has a 5-point scale. 0=clear, no signs of vitiligo; 1=almost clear, only specks of depigmentation present; 2=mild disease, pigmented and depigmented areas are equal; 3=moderate disease, more or complete depigmentation (may include \< 30% hair whitening); 4=severe disease, complete depigmentation plus \> 30% hair whitening. Time to achieve an F-PhGVA response was defined as the number of days from the date of the first application in the Double-Blind Period to the date of the first evaluation at which the participant met the F-PhGVA score. |
| Time to Achieve an T-PhGVA of Clear or Almost Clear | up to 52 weeks | The severity of vitiligo was assessed by the physician using the PhGVA, which has a 5-point scale. 0=clear, no signs of vitiligo; 1=almost clear, only specks of depigmentation present; 2=mild disease, pigmented and depigmented areas are equal; 3=moderate disease, more or complete depigmentation (may include \< 30% hair whitening); 4=severe disease, complete depigmentation plus \> 30% hair whitening. Time to achieve a T-PhGVA response was defined as the number of days from the date of the first application in the Double-Blind Period to the date of the first evaluation at which the participant met the T-PhGVA score. |
| Time to Achieve a PaGIC-V of Very Much Improved or Much Improved | up to 52 weeks | The PaGIC-V is an assessment of improvement by the participant. It is a 7-point scale comparing the vitiligo areas at Baseline with the participant's treated areas of vitiligo at the study visit. The participant answered the following: Since the start of the treatment you've received in this study, your vitiligo in areas treated with the study drug is: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; and 7, very much worse. Time to achieve a PaGIC-V response was defined as the number of days from the date of the first application in the Double-Blind Period to the date of the first evaluation at which the participant met the PaGIC-V score. |
| Percentage of Participants Who Report a PaGIC-V Score of Very Much Improved or Much Improved at Weeks 52, 104, and 156 | Baseline; Weeks 52, 104, and 156 | The PaGIC-V is an assessment of improvement by the participant. It is a 7-point scale comparing the vitiligo areas at Baseline with the participant's treated areas of vitiligo at the study visit. The participant answered the following: Since the start of the treatment you've received in this study, your vitiligo in areas treated with the study drug is: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; and 7, very much worse. |
Countries
United States
Participant flow
Recruitment details
A total of 157 participants with vitiligo were treated at 26 study centers in the United States.
Pre-assignment details
157 participants were randomized to receive 1 of 4 dose strengths of ruxolitinib cream (0.15% once daily \[QD\], 0.5% QD, 1.5% QD, 1.5% twice daily \[BID\]) or vehicle during the 24-week, double-blind (DB), vehicle-controlled treatment period. After the DB period, 11 participants remained on 0.15% QD, and 42 participants who met criteria were re-randomized to 1 of the 3 higher active blinded treatment groups. All other participants remained on the same treatment regimen through Week 52.
Participants by arm
| Arm | Count |
|---|---|
| Vehicle Twice Daily (BID) Vehicle cream BID for 24 weeks (double-blind, vehicle-controlled treatment period), followed by re-randomization to ruxolitinib cream 1.5% BID, 1.5% once daily (QD), or 0.5% QD for Weeks 24 to 52 (continued double-blind treatment period), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension period. | 32 |
| Ruxolitinib Cream 0.15% QD Ruxolitinib cream 0.15% QD in the morning (vehicle cream in the evening) for 24 or 52 weeks. Those who did not achieve a 25% improvement in F-VASI score were re-randomized to receive ruxolitinib cream 0.5% QD in the morning (vehicle cream in the evening), 1.5% QD in the morning (vehicle cream in the evening), or 1.5% BID for Weeks 24 to 52 (continued double-blind treatment period). All participants applied ruxolitinib cream 1.5% BID in the 104-week open-label extension period. | 31 |
| Ruxolitinib Cream 0.5% QD Ruxolitinib cream 0.5% QD in the morning (vehicle cream in the evening) for 52 weeks (combined vehicle-controlled and continued double-blind periods), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension period. | 31 |
| Ruxolitinib Cream 1.5% QD Ruxolitinib cream 1.5% QD in the morning (vehicle cream in the evening) for 52 weeks (combined vehicle-controlled and continued double-blind periods), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension period. | 30 |
| Ruxolitinib Cream 1.5% BID Ruxolitinib cream 1.5% BID for 52 weeks (combined vehicle-controlled and continued double-blind periods), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension period. | 33 |
| Total | 157 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| 104-week Open-Label Extension Period | Adverse Event | 0 | 0 | 1 | 0 | 0 | 0 |
| 104-week Open-Label Extension Period | Lost to Follow-up | 0 | 0 | 3 | 2 | 1 | 6 |
| 104-week Open-Label Extension Period | Other Reason not specified | 0 | 0 | 4 | 1 | 1 | 0 |
| 104-week Open-Label Extension Period | Physician Decision | 0 | 0 | 0 | 0 | 1 | 0 |
| 104-week Open-Label Extension Period | Pregnancy | 0 | 0 | 0 | 0 | 0 | 1 |
| 104-week Open-Label Extension Period | Protocol Violation | 0 | 0 | 0 | 0 | 0 | 1 |
| 104-week Open-Label Extension Period | Withdrawal by Subject | 0 | 0 | 9 | 10 | 13 | 15 |
| DB Period: Day 1 to Week 24 | Adverse Event | 1 | 1 | 0 | 0 | 1 | 0 |
| DB Period: Day 1 to Week 24 | Lost to Follow-up | 1 | 1 | 0 | 0 | 0 | 0 |
| DB Period: Day 1 to Week 24 | Protocol Violation | 0 | 0 | 1 | 1 | 0 | 0 |
| DB Period: Day 1 to Week 24 | Reason not specified | 0 | 0 | 0 | 1 | 0 | 0 |
| DB Period: Day 1 to Week 24 | Withdrawal by Subject | 3 | 3 | 0 | 2 | 2 | 0 |
| DB Period: Weeks 24 to 52 | Adverse Event | 0 | 0 | 0 | 1 | 1 | 0 |
| DB Period: Weeks 24 to 52 | Lost to Follow-up | 0 | 1 | 1 | 1 | 0 | 0 |
| DB Period: Weeks 24 to 52 | Protocol Violation | 0 | 0 | 1 | 0 | 0 | 0 |
| DB Period: Weeks 24 to 52 | Reason not specified | 0 | 0 | 0 | 1 | 0 | 0 |
| DB Period: Weeks 24 to 52 | Withdrawal by Subject | 0 | 0 | 0 | 4 | 1 | 0 |
Baseline characteristics
| Characteristic | Vehicle Twice Daily (BID) | Ruxolitinib Cream 0.15% QD | Ruxolitinib Cream 0.5% QD | Ruxolitinib Cream 1.5% QD | Ruxolitinib Cream 1.5% BID | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 46.3 Years STANDARD_DEVIATION 13.11 | 45.1 Years STANDARD_DEVIATION 11.46 | 53.8 Years STANDARD_DEVIATION 14.34 | 46.7 Years STANDARD_DEVIATION 11.73 | 49.5 Years STANDARD_DEVIATION 12.28 | 48.3 Years STANDARD_DEVIATION 12.85 |
| Face Vitiligo Area Scoring Index (F-VASI) | 1.21 scores on a scale STANDARD_DEVIATION 0.845 | 1.19 scores on a scale STANDARD_DEVIATION 0.754 | 1.22 scores on a scale STANDARD_DEVIATION 0.705 | 1.45 scores on a scale STANDARD_DEVIATION 0.98 | 1.26 scores on a scale STANDARD_DEVIATION 0.807 | 1.26 scores on a scale STANDARD_DEVIATION 0.817 |
| Facial Body Surface Area (F-BSA) Involvement | 1.44 percentage of facial surface area STANDARD_DEVIATION 0.838 | 1.35 percentage of facial surface area STANDARD_DEVIATION 0.858 | 1.40 percentage of facial surface area STANDARD_DEVIATION 0.76 | 1.67 percentage of facial surface area STANDARD_DEVIATION 0.953 | 1.55 percentage of facial surface area STANDARD_DEVIATION 0.892 | 1.48 percentage of facial surface area STANDARD_DEVIATION 0.858 |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 1 Participants | 2 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized Black/African-American | 5 Participants | 0 Participants | 4 Participants | 2 Participants | 3 Participants | 14 Participants |
| Race/Ethnicity, Customized Captured as Other | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Caucasian, Black, and Asian | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Cuban | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 10 Participants | 6 Participants | 6 Participants | 6 Participants | 5 Participants | 33 Participants |
| Race/Ethnicity, Customized Mexican | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Nigerian/West African | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 21 Participants | 22 Participants | 23 Participants | 21 Participants | 27 Participants | 114 Participants |
| Race/Ethnicity, Customized Not Reported | 1 Participants | 2 Participants | 1 Participants | 3 Participants | 0 Participants | 7 Participants |
| Race/Ethnicity, Customized Spanish | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White/Caucasian | 26 Participants | 29 Participants | 25 Participants | 23 Participants | 29 Participants | 132 Participants |
| Sex: Female, Male Female | 20 Participants | 18 Participants | 12 Participants | 19 Participants | 15 Participants | 84 Participants |
| Sex: Female, Male Male | 12 Participants | 13 Participants | 19 Participants | 11 Participants | 18 Participants | 73 Participants |
| Total Body Surface Area (T-BSA) Involvement | 23.54 percentage of total body surface area STANDARD_DEVIATION 20.96 | 17.56 percentage of total body surface area STANDARD_DEVIATION 10.925 | 22.96 percentage of total body surface area STANDARD_DEVIATION 21.449 | 24.81 percentage of total body surface area STANDARD_DEVIATION 20.056 | 21.46 percentage of total body surface area STANDARD_DEVIATION 16.82 | 22.05 percentage of total body surface area STANDARD_DEVIATION 18.377 |
| Total Body Vitiligo Area Scoring Index (T-VASI) | 19.40 scores on a scale STANDARD_DEVIATION 18.512 | 14.57 scores on a scale STANDARD_DEVIATION 9.049 | 18.43 scores on a scale STANDARD_DEVIATION 15.363 | 20.55 scores on a scale STANDARD_DEVIATION 18.488 | 16.94 scores on a scale STANDARD_DEVIATION 14.256 | 17.96 scores on a scale STANDARD_DEVIATION 15.451 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 31 | 0 / 45 | 0 / 44 | 0 / 130 |
| other Total, other adverse events | 14 / 32 | 19 / 31 | 23 / 45 | 20 / 44 | 45 / 130 |
| serious Total, serious adverse events | 0 / 32 | 0 / 31 | 2 / 45 | 1 / 44 | 4 / 130 |
Outcome results
Primary
Percentage of Participants Treated With Ruxolitinib Cream Who Achieved a ≥ 50% Improvement From Baseline in Facial Assessment of the Vitiligo Area and Severity Index Score (F-VASI50) Compared With Participants Treated With Vehicle at Week 24
An F-VASI50 responder achieved at least 50% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of body surface area \[BSA\]) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement).
Time frame: Baseline; Week 24
Population: Intent-to-Treat (ITT) Population: all randomized participants. Treatment groups were to be defined according to the treatment assignment at the time of randomization regardless of the actual ruxolitinib cream or vehicle cream participants might have applied during their participation in the study. Missing post-Baseline values were considered as not having achieved responses for visits up to Week 52.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vehicle Twice Daily (BID) | Percentage of Participants Treated With Ruxolitinib Cream Who Achieved a ≥ 50% Improvement From Baseline in Facial Assessment of the Vitiligo Area and Severity Index Score (F-VASI50) Compared With Participants Treated With Vehicle at Week 24 | 3.1 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants Treated With Ruxolitinib Cream Who Achieved a ≥ 50% Improvement From Baseline in Facial Assessment of the Vitiligo Area and Severity Index Score (F-VASI50) Compared With Participants Treated With Vehicle at Week 24 | 32.3 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants Treated With Ruxolitinib Cream Who Achieved a ≥ 50% Improvement From Baseline in Facial Assessment of the Vitiligo Area and Severity Index Score (F-VASI50) Compared With Participants Treated With Vehicle at Week 24 | 25.8 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants Treated With Ruxolitinib Cream Who Achieved a ≥ 50% Improvement From Baseline in Facial Assessment of the Vitiligo Area and Severity Index Score (F-VASI50) Compared With Participants Treated With Vehicle at Week 24 | 50.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants Treated With Ruxolitinib Cream Who Achieved a ≥ 50% Improvement From Baseline in Facial Assessment of the Vitiligo Area and Severity Index Score (F-VASI50) Compared With Participants Treated With Vehicle at Week 24 | 45.5 percentage of participants |
p-value: 0.005795% CI: [1.73, 640.85]exact logistic regression
p-value: 0.024395% CI: [1.24, 487.28]exact logistic regression
p-value: <0.000195% CI: [3.74, 1305.2]exact logistic regression
p-value: 0.000195% CI: [3.28, 1121.4]exact logistic regression
Secondary
Dose Response on Percentage Change From Baseline in F-VASI
Time frame: up to 156 weeks
Population: Based on the data for percentage change from Baseline in F-VASI and T-VASI scores during the treatment periods, the Emax model was not appropriate; therefore, the dose responses were not assessed.
Secondary
Mean Change From Baseline in F-VASI Score at Week 24
F-VASI was measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline; Week 24
Population: ITT Population. Only participants with available data were analyzed. Mixed-model for Repeated Measures (MMRM) model for post-Baseline measures: (response variable = treatment + stratification factor \[age ≤30 versus \>30\] + visit + treatment\*visit). All post-Baseline visits up to Week 24 were included in the model.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Vehicle Twice Daily (BID) | Mean Change From Baseline in F-VASI Score at Week 24 | 0.05 scores on a scale | Standard Error 0.11 |
| Ruxolitinib Cream 0.15% QD | Mean Change From Baseline in F-VASI Score at Week 24 | -0.39 scores on a scale | Standard Error 0.11 |
| Ruxolitinib Cream 0.5% QD | Mean Change From Baseline in F-VASI Score at Week 24 | -0.35 scores on a scale | Standard Error 0.11 |
| Ruxolitinib Cream 1.5% QD | Mean Change From Baseline in F-VASI Score at Week 24 | -0.63 scores on a scale | Standard Error 0.11 |
| Ruxolitinib Cream 1.5% BID | Mean Change From Baseline in F-VASI Score at Week 24 | -0.46 scores on a scale | Standard Error 0.1 |
p-value: 0.005695% CI: [-0.75, -0.13]Log Rank
p-value: 0.009595% CI: [-0.7, -0.1]Log Rank
p-value: <0.000195% CI: [-0.99, -0.37]Log Rank
p-value: 0.001195% CI: [-0.8, -0.21]Log Rank
Secondary
Mean Change From Baseline in F-VASI Score at Weeks 52, 104, and 156
F-VASI was measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline; Weeks 52, 104, and 156
Population: ITT Population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle Twice Daily (BID) | Mean Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Baseline | 0.77 scores on a scale | Standard Deviation 0.387 |
| Vehicle Twice Daily (BID) | Mean Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Change from Baseline at Week 52 | -0.59 scores on a scale | Standard Deviation 0.459 |
| Vehicle Twice Daily (BID) | Mean Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Change from Baseline at Week 104 | -0.66 scores on a scale | Standard Deviation 0.444 |
| Vehicle Twice Daily (BID) | Mean Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Change from Baseline at Week 156 | -0.66 scores on a scale | Standard Deviation 0.124 |
| Ruxolitinib Cream 0.15% QD | Mean Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Change from Baseline at Week 156 | -0.98 scores on a scale | Standard Deviation 1.092 |
| Ruxolitinib Cream 0.15% QD | Mean Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Change from Baseline at Week 104 | -0.97 scores on a scale | Standard Deviation 1.061 |
| Ruxolitinib Cream 0.15% QD | Mean Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Baseline | 1.21 scores on a scale | Standard Deviation 0.891 |
| Ruxolitinib Cream 0.15% QD | Mean Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Change from Baseline at Week 52 | -0.67 scores on a scale | Standard Deviation 0.811 |
| Ruxolitinib Cream 0.5% QD | Mean Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Change from Baseline at Week 104 | -1.79 scores on a scale | Standard Deviation 1.077 |
| Ruxolitinib Cream 0.5% QD | Mean Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Change from Baseline at Week 52 | -1.02 scores on a scale | Standard Deviation 1.058 |
| Ruxolitinib Cream 0.5% QD | Mean Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Baseline | 1.66 scores on a scale | Standard Deviation 0.993 |
| Ruxolitinib Cream 0.5% QD | Mean Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Change from Baseline at Week 156 | -1.40 scores on a scale | Standard Deviation 1.018 |
| Ruxolitinib Cream 1.5% QD | Mean Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Baseline | 1.14 scores on a scale | Standard Deviation 0.714 |
| Ruxolitinib Cream 1.5% QD | Mean Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Change from Baseline at Week 52 | -0.58 scores on a scale | Standard Deviation 0.783 |
| Ruxolitinib Cream 1.5% QD | Mean Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Change from Baseline at Week 104 | -0.87 scores on a scale | Standard Deviation 0.903 |
| Ruxolitinib Cream 1.5% QD | Mean Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Change from Baseline at Week 156 | -0.65 scores on a scale | Standard Deviation 0.557 |
| Ruxolitinib Cream 1.5% BID | Mean Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Baseline | 1.22 scores on a scale | Standard Deviation 0.705 |
| Ruxolitinib Cream 1.5% BID | Mean Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Change from Baseline at Week 156 | -0.71 scores on a scale | Standard Deviation 0.49 |
| Ruxolitinib Cream 1.5% BID | Mean Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Change from Baseline at Week 52 | -0.58 scores on a scale | Standard Deviation 0.578 |
| Ruxolitinib Cream 1.5% BID | Mean Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Change from Baseline at Week 104 | -1.00 scores on a scale | Standard Deviation 0.697 |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Mean Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Change from Baseline at Week 52 | -0.74 scores on a scale | Standard Deviation 0.797 |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Mean Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Baseline | 1.45 scores on a scale | Standard Deviation 0.98 |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Mean Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Change from Baseline at Week 104 | -1.17 scores on a scale | Standard Deviation 0.961 |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Mean Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Change from Baseline at Week 156 | -0.95 scores on a scale | Standard Deviation 0.949 |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Mean Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Change from Baseline at Week 104 | -0.99 scores on a scale | Standard Deviation 0.817 |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Mean Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Baseline | 1.26 scores on a scale | Standard Deviation 0.808 |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Mean Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Change from Baseline at Week 52 | -0.76 scores on a scale | Standard Deviation 0.61 |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Mean Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Change from Baseline at Week 156 | -1.23 scores on a scale | Standard Deviation 0.887 |
Secondary
Mean Change From Baseline in T-VASI Score at Week 24
T-VASI was calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement). Change from Baseline (BL) was calculated as the post-BL value minus the BL value.
Time frame: Baseline; Week 24
Population: ITT Population. Only participants with available data were analyzed. MMRM model for post-Baseline measures: (response variable = treatment + stratification factor \[age ≤30 versus \>30\] + visit + treatment\*visit). All post-Baseline visits up to Week 24 were included in the model.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Vehicle Twice Daily (BID) | Mean Change From Baseline in T-VASI Score at Week 24 | 0.57 scores on a scale | Standard Error 0.92 |
| Ruxolitinib Cream 0.15% QD | Mean Change From Baseline in T-VASI Score at Week 24 | -2.27 scores on a scale | Standard Error 0.94 |
| Ruxolitinib Cream 0.5% QD | Mean Change From Baseline in T-VASI Score at Week 24 | -2.18 scores on a scale | Standard Error 0.88 |
| Ruxolitinib Cream 1.5% QD | Mean Change From Baseline in T-VASI Score at Week 24 | -4.51 scores on a scale | Standard Error 0.94 |
| Ruxolitinib Cream 1.5% BID | Mean Change From Baseline in T-VASI Score at Week 24 | -3.52 scores on a scale | Standard Error 0.87 |
p-value: 0.032695% CI: [-5.44, -0.24]Log Rank
p-value: 0.033395% CI: [-5.26, -0.22]Log Rank
p-value: 0.000295% CI: [-7.68, -2.48]Log Rank
p-value: 0.001695% CI: [-6.59, -1.57]Log Rank
Secondary
Mean Change From Baseline in T-VASI Score at Weeks 52, 104, and 156
T-VASI was calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement). Change from BL was calculated as the post-BL value minus the BL value.
Time frame: Baseline; Weeks 52, 104, and 156
Population: ITT Population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle Twice Daily (BID) | Mean Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Change from Baseline at Week 156 | -2.33 scores on a scale | Standard Deviation 0.269 |
| Vehicle Twice Daily (BID) | Mean Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Baseline | 9.56 scores on a scale | Standard Deviation 7.09 |
| Vehicle Twice Daily (BID) | Mean Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Change from Baseline at Week 104 | -6.02 scores on a scale | Standard Deviation 5.476 |
| Vehicle Twice Daily (BID) | Mean Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Change from Baseline at Week 52 | -4.59 scores on a scale | Standard Deviation 4.979 |
| Ruxolitinib Cream 0.15% QD | Mean Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Change from Baseline at Week 104 | -5.32 scores on a scale | Standard Deviation 5.615 |
| Ruxolitinib Cream 0.15% QD | Mean Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Baseline | 13.47 scores on a scale | Standard Deviation 11.655 |
| Ruxolitinib Cream 0.15% QD | Mean Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Change from Baseline at Week 52 | -2.88 scores on a scale | Standard Deviation 2.934 |
| Ruxolitinib Cream 0.15% QD | Mean Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Change from Baseline at Week 156 | -10.23 scores on a scale | Standard Deviation 13.533 |
| Ruxolitinib Cream 0.5% QD | Mean Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Change from Baseline at Week 104 | -9.71 scores on a scale | Standard Deviation 9.398 |
| Ruxolitinib Cream 0.5% QD | Mean Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Change from Baseline at Week 156 | -11.31 scores on a scale | Standard Deviation 12.185 |
| Ruxolitinib Cream 0.5% QD | Mean Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Change from Baseline at Week 52 | -3.21 scores on a scale | Standard Deviation 4.536 |
| Ruxolitinib Cream 0.5% QD | Mean Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Baseline | 22.82 scores on a scale | Standard Deviation 19.187 |
| Ruxolitinib Cream 1.5% QD | Mean Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Change from Baseline at Week 156 | -7.82 scores on a scale | Standard Deviation 4.209 |
| Ruxolitinib Cream 1.5% QD | Mean Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Baseline | 20.75 scores on a scale | Standard Deviation 15.973 |
| Ruxolitinib Cream 1.5% QD | Mean Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Change from Baseline at Week 52 | -3.88 scores on a scale | Standard Deviation 5.642 |
| Ruxolitinib Cream 1.5% QD | Mean Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Change from Baseline at Week 104 | -6.62 scores on a scale | Standard Deviation 7.054 |
| Ruxolitinib Cream 1.5% BID | Mean Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Change from Baseline at Week 104 | -7.19 scores on a scale | Standard Deviation 9.079 |
| Ruxolitinib Cream 1.5% BID | Mean Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Baseline | 18.43 scores on a scale | Standard Deviation 15.363 |
| Ruxolitinib Cream 1.5% BID | Mean Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Change from Baseline at Week 156 | -4.72 scores on a scale | Standard Deviation 3.622 |
| Ruxolitinib Cream 1.5% BID | Mean Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Change from Baseline at Week 52 | -3.97 scores on a scale | Standard Deviation 6.284 |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Mean Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Change from Baseline at Week 52 | -7.37 scores on a scale | Standard Deviation 7.403 |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Mean Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Change from Baseline at Week 104 | -10.77 scores on a scale | Standard Deviation 9.658 |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Mean Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Baseline | 20.55 scores on a scale | Standard Deviation 18.488 |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Mean Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Change from Baseline at Week 156 | -7.02 scores on a scale | Standard Deviation 9.577 |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Mean Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Change from Baseline at Week 156 | -8.77 scores on a scale | Standard Deviation 4.996 |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Mean Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Change from Baseline at Week 52 | -6.14 scores on a scale | Standard Deviation 7.442 |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Mean Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Change from Baseline at Week 104 | -7.74 scores on a scale | Standard Deviation 5.927 |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Mean Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Baseline | 16.94 scores on a scale | Standard Deviation 14.256 |
Secondary
Mean Change From Baseline in VETF Scale Scores at Week 24: Total Percentage Area
The VETF-proposed system combines analysis of extent (0%-100% BSA), stage of disease (staging), and disease progression (spreading); each component is evaluated and reported independently. Staging is based on cutaneous and hair pigmentation in vitiligo patches. Disease is staged 0 to 4 on the largest macule in each of 5 body regions, except hands and feet, which are assessed separately and globally as 1 unique area. Stage 0=normal pigmentation, Stage 1=incomplete pigmentation, Stage 2=complete depigmentation (a few white hairs do not change stage), Stage 3=partial hair whitening (\<30%), Stage 4=complete hair whitening; total score of 0 (less severe disease) to 20 (more severe disease). Disease progression is based on assessing the largest patch in each of 5 body areas: -1=regressive vitiligo (ongoing subclinical repigmentation), 0=similar limits, 1=progressive vitiligo (ongoing subclinical depigmentation); total score of -5 (improving disease) to +5 (more severe disease spread).
Time frame: Baseline; Week 24
Population: ITT Population. Only participants with available data were analyzed. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle Twice Daily (BID) | Mean Change From Baseline in VETF Scale Scores at Week 24: Total Percentage Area | Baseline | 22.81 scores on a scale | Standard Deviation 20.843 |
| Vehicle Twice Daily (BID) | Mean Change From Baseline in VETF Scale Scores at Week 24: Total Percentage Area | Change from Baseline at Week 24 | 0.38 scores on a scale | Standard Deviation 1.329 |
| Ruxolitinib Cream 0.15% QD | Mean Change From Baseline in VETF Scale Scores at Week 24: Total Percentage Area | Baseline | 16.26 scores on a scale | Standard Deviation 11.006 |
| Ruxolitinib Cream 0.15% QD | Mean Change From Baseline in VETF Scale Scores at Week 24: Total Percentage Area | Change from Baseline at Week 24 | -1.08 scores on a scale | Standard Deviation 3.867 |
| Ruxolitinib Cream 0.5% QD | Mean Change From Baseline in VETF Scale Scores at Week 24: Total Percentage Area | Baseline | 22.35 scores on a scale | Standard Deviation 20.878 |
| Ruxolitinib Cream 0.5% QD | Mean Change From Baseline in VETF Scale Scores at Week 24: Total Percentage Area | Change from Baseline at Week 24 | -2.43 scores on a scale | Standard Deviation 4.797 |
| Ruxolitinib Cream 1.5% QD | Mean Change From Baseline in VETF Scale Scores at Week 24: Total Percentage Area | Change from Baseline at Week 24 | -3.27 scores on a scale | Standard Deviation 6.744 |
| Ruxolitinib Cream 1.5% QD | Mean Change From Baseline in VETF Scale Scores at Week 24: Total Percentage Area | Baseline | 24.63 scores on a scale | Standard Deviation 22.236 |
| Ruxolitinib Cream 1.5% BID | Mean Change From Baseline in VETF Scale Scores at Week 24: Total Percentage Area | Baseline | 20.79 scores on a scale | Standard Deviation 16.192 |
| Ruxolitinib Cream 1.5% BID | Mean Change From Baseline in VETF Scale Scores at Week 24: Total Percentage Area | Change from Baseline at Week 24 | -2.71 scores on a scale | Standard Deviation 4.591 |
Secondary
Mean Change From Baseline in VETF Scale Scores at Week 24: Total Staging
The VETF-proposed system combines analysis of extent (0%-100% BSA), stage of disease (staging), and disease progression (spreading); each component is evaluated and reported independently. Staging is based on cutaneous and hair pigmentation in vitiligo patches. Disease is staged 0 to 4 on the largest macule in each of 5 body regions, except hands and feet, which are assessed separately and globally as 1 unique area. Stage 0=normal pigmentation, Stage 1=incomplete pigmentation, Stage 2=complete depigmentation (a few white hairs do not change stage), Stage 3=partial hair whitening (\<30%), Stage 4=complete hair whitening; total score of 0 (less severe disease) to 20 (more severe disease). Disease progression is based on assessing the largest patch in each of 5 body areas: -1=regressive vitiligo (ongoing subclinical repigmentation), 0=similar limits, 1=progressive vitiligo (ongoing subclinical depigmentation); total score of -5 (improving disease) to +5 (more severe disease spread).
Time frame: Baseline; Week 24
Population: ITT Population. Only participants with available data were analyzed. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle Twice Daily (BID) | Mean Change From Baseline in VETF Scale Scores at Week 24: Total Staging | Baseline | 10.03 scores on a scale | Standard Deviation 3.515 |
| Vehicle Twice Daily (BID) | Mean Change From Baseline in VETF Scale Scores at Week 24: Total Staging | Change from Baseline at Week 24 | -1.15 scores on a scale | Standard Deviation 3.184 |
| Ruxolitinib Cream 0.15% QD | Mean Change From Baseline in VETF Scale Scores at Week 24: Total Staging | Baseline | 9.29 scores on a scale | Standard Deviation 3.013 |
| Ruxolitinib Cream 0.15% QD | Mean Change From Baseline in VETF Scale Scores at Week 24: Total Staging | Change from Baseline at Week 24 | -1.62 scores on a scale | Standard Deviation 2.282 |
| Ruxolitinib Cream 0.5% QD | Mean Change From Baseline in VETF Scale Scores at Week 24: Total Staging | Baseline | 10.03 scores on a scale | Standard Deviation 3.945 |
| Ruxolitinib Cream 0.5% QD | Mean Change From Baseline in VETF Scale Scores at Week 24: Total Staging | Change from Baseline at Week 24 | -1.57 scores on a scale | Standard Deviation 2.687 |
| Ruxolitinib Cream 1.5% QD | Mean Change From Baseline in VETF Scale Scores at Week 24: Total Staging | Change from Baseline at Week 24 | -1.96 scores on a scale | Standard Deviation 3.561 |
| Ruxolitinib Cream 1.5% QD | Mean Change From Baseline in VETF Scale Scores at Week 24: Total Staging | Baseline | 9.97 scores on a scale | Standard Deviation 3 |
| Ruxolitinib Cream 1.5% BID | Mean Change From Baseline in VETF Scale Scores at Week 24: Total Staging | Baseline | 8.42 scores on a scale | Standard Deviation 3.464 |
| Ruxolitinib Cream 1.5% BID | Mean Change From Baseline in VETF Scale Scores at Week 24: Total Staging | Change from Baseline at Week 24 | -0.74 scores on a scale | Standard Deviation 2.633 |
Secondary
Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Percentage Area
The VETF-proposed system combines analysis of extent (0%-100% BSA), stage of disease (staging), and disease progression (spreading); each component is evaluated and reported independently. Staging is based on cutaneous and hair pigmentation in vitiligo patches. Disease is staged 0 to 4 on the largest macule in each of 5 body regions, except hands and feet, which are assessed separately and globally as 1 unique area. Stage 0=normal pigmentation, Stage 1=incomplete pigmentation, Stage 2=complete depigmentation (a few white hairs do not change stage), Stage 3=partial hair whitening (\<30%), Stage 4=complete hair whitening; total score of 0 (less severe disease) to 20 (more severe disease). Disease progression is based on assessing the largest patch in each of 5 body areas: -1=regressive vitiligo (ongoing subclinical repigmentation), 0=similar limits, 1=progressive vitiligo (ongoing subclinical depigmentation); total score of -5 (improving disease) to +5 (more severe disease spread).
Time frame: Baseline; Weeks 52 and 104
Population: ITT Population. Only participants with available data were analyzed. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle Twice Daily (BID) | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Percentage Area | Change from Baseline at Week 104 | -3.89 scores on a scale | Standard Deviation 4.226 |
| Vehicle Twice Daily (BID) | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Percentage Area | Change from Baseline at Week 52 | -3.10 scores on a scale | Standard Deviation 3.814 |
| Vehicle Twice Daily (BID) | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Percentage Area | Baseline | 9.18 scores on a scale | Standard Deviation 6.509 |
| Ruxolitinib Cream 0.15% QD | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Percentage Area | Change from Baseline at Week 52 | -1.86 scores on a scale | Standard Deviation 2.905 |
| Ruxolitinib Cream 0.15% QD | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Percentage Area | Baseline | 16.43 scores on a scale | Standard Deviation 11.979 |
| Ruxolitinib Cream 0.15% QD | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Percentage Area | Change from Baseline at Week 104 | -4.75 scores on a scale | Standard Deviation 5.994 |
| Ruxolitinib Cream 0.5% QD | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Percentage Area | Change from Baseline at Week 104 | -5.11 scores on a scale | Standard Deviation 4.226 |
| Ruxolitinib Cream 0.5% QD | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Percentage Area | Baseline | 24.50 scores on a scale | Standard Deviation 21.841 |
| Ruxolitinib Cream 0.5% QD | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Percentage Area | Change from Baseline at Week 52 | -1.17 scores on a scale | Standard Deviation 3.486 |
| Ruxolitinib Cream 1.5% QD | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Percentage Area | Change from Baseline at Week 52 | -1.92 scores on a scale | Standard Deviation 6.211 |
| Ruxolitinib Cream 1.5% QD | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Percentage Area | Baseline | 24.50 scores on a scale | Standard Deviation 18.798 |
| Ruxolitinib Cream 1.5% QD | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Percentage Area | Change from Baseline at Week 104 | -4.44 scores on a scale | Standard Deviation 7.367 |
| Ruxolitinib Cream 1.5% BID | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Percentage Area | Change from Baseline at Week 52 | -3.93 scores on a scale | Standard Deviation 7.191 |
| Ruxolitinib Cream 1.5% BID | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Percentage Area | Baseline | 22.35 scores on a scale | Standard Deviation 20.878 |
| Ruxolitinib Cream 1.5% BID | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Percentage Area | Change from Baseline at Week 104 | -8.00 scores on a scale | Standard Deviation 10.392 |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Percentage Area | Baseline | 24.63 scores on a scale | Standard Deviation 22.236 |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Percentage Area | Change from Baseline at Week 104 | -7.78 scores on a scale | Standard Deviation 8.695 |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Percentage Area | Change from Baseline at Week 52 | -5.71 scores on a scale | Standard Deviation 8.463 |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Percentage Area | Change from Baseline at Week 104 | -6.26 scores on a scale | Standard Deviation 6.682 |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Percentage Area | Change from Baseline at Week 52 | -4.48 scores on a scale | Standard Deviation 6.127 |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Percentage Area | Baseline | 20.79 scores on a scale | Standard Deviation 16.192 |
Secondary
Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Spreading
The VETF-proposed system combines analysis of extent (0%-100% BSA), stage of disease (staging), and disease progression (spreading); each component is evaluated and reported independently. Staging is based on cutaneous and hair pigmentation in vitiligo patches. Disease is staged 0 to 4 on the largest macule in each of 5 body regions, except hands and feet, which are assessed separately and globally as 1 unique area. Stage 0=normal pigmentation, Stage 1=incomplete pigmentation, Stage 2=complete depigmentation (a few white hairs do not change stage), Stage 3=partial hair whitening (\<30%), Stage 4=complete hair whitening; total score of 0 (less severe disease) to 20 (more severe disease). Disease progression is based on assessing the largest patch in each of 5 body areas: -1=regressive vitiligo (ongoing subclinical repigmentation), 0=similar limits, 1=progressive vitiligo (ongoing subclinical depigmentation); total score of -5 (improving disease) to +5 (more severe disease spread).
Time frame: Baseline; Weeks 52 and 104
Population: ITT Population. Only participants with available data were analyzed. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle Twice Daily (BID) | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Spreading | Change from Baseline at Week 104 | -5.00 scores on a scale | Standard Deviation 4.153 |
| Vehicle Twice Daily (BID) | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Spreading | Change from Baseline at Week 52 | -4.70 scores on a scale | Standard Deviation 3.683 |
| Vehicle Twice Daily (BID) | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Spreading | Baseline | 2.73 scores on a scale | Standard Deviation 2.328 |
| Ruxolitinib Cream 0.15% QD | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Spreading | Change from Baseline at Week 52 | -4.14 scores on a scale | Standard Deviation 3.592 |
| Ruxolitinib Cream 0.15% QD | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Spreading | Baseline | 2.43 scores on a scale | Standard Deviation 2.277 |
| Ruxolitinib Cream 0.15% QD | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Spreading | Change from Baseline at Week 104 | -4.25 scores on a scale | Standard Deviation 3.196 |
| Ruxolitinib Cream 0.5% QD | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Spreading | Change from Baseline at Week 104 | -4.22 scores on a scale | Standard Deviation 3.667 |
| Ruxolitinib Cream 0.5% QD | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Spreading | Baseline | 1.21 scores on a scale | Standard Deviation 2.607 |
| Ruxolitinib Cream 0.5% QD | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Spreading | Change from Baseline at Week 52 | -3.83 scores on a scale | Standard Deviation 3.538 |
| Ruxolitinib Cream 1.5% QD | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Spreading | Change from Baseline at Week 52 | -3.85 scores on a scale | Standard Deviation 3.211 |
| Ruxolitinib Cream 1.5% QD | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Spreading | Baseline | 2.21 scores on a scale | Standard Deviation 1.968 |
| Ruxolitinib Cream 1.5% QD | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Spreading | Change from Baseline at Week 104 | -5.11 scores on a scale | Standard Deviation 3.371 |
| Ruxolitinib Cream 1.5% BID | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Spreading | Change from Baseline at Week 52 | -3.48 scores on a scale | Standard Deviation 3.622 |
| Ruxolitinib Cream 1.5% BID | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Spreading | Baseline | 1.84 scores on a scale | Standard Deviation 2.238 |
| Ruxolitinib Cream 1.5% BID | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Spreading | Change from Baseline at Week 104 | -3.16 scores on a scale | Standard Deviation 3.516 |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Spreading | Baseline | 1.83 scores on a scale | Standard Deviation 2.102 |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Spreading | Change from Baseline at Week 104 | -3.56 scores on a scale | Standard Deviation 3.034 |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Spreading | Change from Baseline at Week 52 | -3.86 scores on a scale | Standard Deviation 3.395 |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Spreading | Change from Baseline at Week 104 | -3.26 scores on a scale | Standard Deviation 3.034 |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Spreading | Change from Baseline at Week 52 | -3.66 scores on a scale | Standard Deviation 2.742 |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Spreading | Baseline | 1.21 scores on a scale | Standard Deviation 2.233 |
Secondary
Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Staging
The VETF-proposed system combines analysis of extent (0%-100% BSA), stage of disease (staging), and disease progression (spreading); each component is evaluated and reported independently. Staging is based on cutaneous and hair pigmentation in vitiligo patches. Disease is staged 0 to 4 on the largest macule in each of 5 body regions, except hands and feet, which are assessed separately and globally as 1 unique area. Stage 0=normal pigmentation, Stage 1=incomplete pigmentation, Stage 2=complete depigmentation (a few white hairs do not change stage), Stage 3=partial hair whitening (\<30%), Stage 4=complete hair whitening; total score of 0 (less severe disease) to 20 (more severe disease). Disease progression is based on assessing the largest patch in each of 5 body areas: -1=regressive vitiligo (ongoing subclinical repigmentation), 0=similar limits, 1=progressive vitiligo (ongoing subclinical depigmentation); total score of -5 (improving disease) to +5 (more severe disease spread).
Time frame: Baseline; Weeks 52 and 104
Population: ITT Population. Only participants with available data were analyzed. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle Twice Daily (BID) | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Staging | Change from Baseline at Week 104 | -3.44 scores on a scale | Standard Deviation 3.358 |
| Vehicle Twice Daily (BID) | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Staging | Change from Baseline at Week 52 | -3.10 scores on a scale | Standard Deviation 3.247 |
| Vehicle Twice Daily (BID) | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Staging | Baseline | 8.64 scores on a scale | Standard Deviation 2.908 |
| Ruxolitinib Cream 0.15% QD | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Staging | Change from Baseline at Week 52 | -1.29 scores on a scale | Standard Deviation 2.301 |
| Ruxolitinib Cream 0.15% QD | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Staging | Baseline | 8.43 scores on a scale | Standard Deviation 2.901 |
| Ruxolitinib Cream 0.15% QD | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Staging | Change from Baseline at Week 104 | -2.75 scores on a scale | Standard Deviation 3.694 |
| Ruxolitinib Cream 0.5% QD | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Staging | Change from Baseline at Week 104 | -2.22 scores on a scale | Standard Deviation 3.866 |
| Ruxolitinib Cream 0.5% QD | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Staging | Baseline | 11.29 scores on a scale | Standard Deviation 2.128 |
| Ruxolitinib Cream 0.5% QD | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Staging | Change from Baseline at Week 52 | -2.17 scores on a scale | Standard Deviation 3.157 |
| Ruxolitinib Cream 1.5% QD | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Staging | Change from Baseline at Week 52 | -2.62 scores on a scale | Standard Deviation 2.844 |
| Ruxolitinib Cream 1.5% QD | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Staging | Baseline | 10.07 scores on a scale | Standard Deviation 3.668 |
| Ruxolitinib Cream 1.5% QD | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Staging | Change from Baseline at Week 104 | -2.89 scores on a scale | Standard Deviation 1.537 |
| Ruxolitinib Cream 1.5% BID | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Staging | Change from Baseline at Week 52 | -2.41 scores on a scale | Standard Deviation 3.03 |
| Ruxolitinib Cream 1.5% BID | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Staging | Baseline | 10.03 scores on a scale | Standard Deviation 3.945 |
| Ruxolitinib Cream 1.5% BID | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Staging | Change from Baseline at Week 104 | -2.84 scores on a scale | Standard Deviation 2.754 |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Staging | Baseline | 9.97 scores on a scale | Standard Deviation 3 |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Staging | Change from Baseline at Week 104 | -4.00 scores on a scale | Standard Deviation 3.049 |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Staging | Change from Baseline at Week 52 | -3.48 scores on a scale | Standard Deviation 2.96 |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Staging | Change from Baseline at Week 104 | -1.68 scores on a scale | Standard Deviation 2.73 |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Staging | Change from Baseline at Week 52 | -1.38 scores on a scale | Standard Deviation 2.555 |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Staging | Baseline | 8.42 scores on a scale | Standard Deviation 3.464 |
Secondary
Mean Change From Baseline in Vitiligo European Task Force (VETF) Scale Scores at Week 24: Total Spreading
The VETF-proposed system combines analysis of extent (0%-100% BSA), stage of disease (staging), and disease progression (spreading); each component is evaluated and reported independently. Staging is based on cutaneous and hair pigmentation in vitiligo patches. Disease is staged 0 to 4 on the largest macule in each of 5 body regions, except hands and feet, which are assessed separately and globally as 1 unique area. Stage 0=normal pigmentation, Stage 1=incomplete pigmentation, Stage 2=complete depigmentation (a few white hairs do not change stage), Stage 3=partial hair whitening (\<30%), Stage 4=complete hair whitening; total score of 0 (less severe disease) to 20 (more severe disease). Disease progression is based on assessing the largest patch in each of 5 body areas: -1=regressive vitiligo (ongoing subclinical repigmentation), 0=similar limits, 1=progressive vitiligo (ongoing subclinical depigmentation); total score of -5 (improving disease) to +5 (more severe disease spread).
Time frame: Baseline; Week 24
Population: ITT Population. Only participants with available data were analyzed. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle Twice Daily (BID) | Mean Change From Baseline in Vitiligo European Task Force (VETF) Scale Scores at Week 24: Total Spreading | Baseline | 1.78 scores on a scale | Standard Deviation 2.166 |
| Vehicle Twice Daily (BID) | Mean Change From Baseline in Vitiligo European Task Force (VETF) Scale Scores at Week 24: Total Spreading | Change from Baseline at Week 24 | -1.12 scores on a scale | Standard Deviation 2.566 |
| Ruxolitinib Cream 0.15% QD | Mean Change From Baseline in Vitiligo European Task Force (VETF) Scale Scores at Week 24: Total Spreading | Baseline | 2.74 scores on a scale | Standard Deviation 2.422 |
| Ruxolitinib Cream 0.15% QD | Mean Change From Baseline in Vitiligo European Task Force (VETF) Scale Scores at Week 24: Total Spreading | Change from Baseline at Week 24 | -3.15 scores on a scale | Standard Deviation 3.246 |
| Ruxolitinib Cream 0.5% QD | Mean Change From Baseline in Vitiligo European Task Force (VETF) Scale Scores at Week 24: Total Spreading | Baseline | 1.84 scores on a scale | Standard Deviation 2.238 |
| Ruxolitinib Cream 0.5% QD | Mean Change From Baseline in Vitiligo European Task Force (VETF) Scale Scores at Week 24: Total Spreading | Change from Baseline at Week 24 | -3.27 scores on a scale | Standard Deviation 3.532 |
| Ruxolitinib Cream 1.5% QD | Mean Change From Baseline in Vitiligo European Task Force (VETF) Scale Scores at Week 24: Total Spreading | Change from Baseline at Week 24 | -3.12 scores on a scale | Standard Deviation 2.971 |
| Ruxolitinib Cream 1.5% QD | Mean Change From Baseline in Vitiligo European Task Force (VETF) Scale Scores at Week 24: Total Spreading | Baseline | 1.83 scores on a scale | Standard Deviation 2.102 |
| Ruxolitinib Cream 1.5% BID | Mean Change From Baseline in Vitiligo European Task Force (VETF) Scale Scores at Week 24: Total Spreading | Baseline | 1.21 scores on a scale | Standard Deviation 2.233 |
| Ruxolitinib Cream 1.5% BID | Mean Change From Baseline in Vitiligo European Task Force (VETF) Scale Scores at Week 24: Total Spreading | Change from Baseline at Week 24 | -3.58 scores on a scale | Standard Deviation 3.042 |
Secondary
Number of Participants Who Applied Ruxolitinib 1.5% Cream BID Throughout Study Participation With Any TEAE and Any Grade 3 or Higher TEAE
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. A TEAE was an AE reported for the first time or the worsening of a pre-existing event after first application of study drug. The severity of AEs was assessed using CTCAE v4.03 Grades 1 through 4. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent intervention indicated.
Time frame: up to Week 156
Population: Safety Population. Treatment groups for this population were to be determined according to the actual treatment the participant received on Day 1. Analysis was only conducted in participants who received ruxolitinib cream 1.5% BID on Day 1.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Number of Participants Who Applied Ruxolitinib 1.5% Cream BID Throughout Study Participation With Any TEAE and Any Grade 3 or Higher TEAE | Any TEAE | 26 Participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Number of Participants Who Applied Ruxolitinib 1.5% Cream BID Throughout Study Participation With Any TEAE and Any Grade 3 or Higher TEAE | Any Grade 3 or higher TEAE | 1 Participants |
Secondary
Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE From Week 24 to Week 52
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. A TEAE was an AE reported for the first time or the worsening of a pre-existing event after first application of study drug. The severity of AEs was assessed using CTCAE v4.03 Grades 1 through 4. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent intervention indicated.
Time frame: Week 24 to Week 52
Population: Safety Population. Treatment groups for this population were to be determined according to the actual treatment the participant received on Day 1. Analysis was conducted in participants who were randomized to ruxolitinib cream 0.15% QD and vehicle groups in the vehicle-controlled period (Day 1 to Week 24) and then had a dose in the continued double-blind period (Week 24 to Week 52).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vehicle Twice Daily (BID) | Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE From Week 24 to Week 52 | Any TEAE | 9 Participants |
| Vehicle Twice Daily (BID) | Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE From Week 24 to Week 52 | Any Grade 3 or higher TEAE | 0 Participants |
| Ruxolitinib Cream 0.15% QD | Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE From Week 24 to Week 52 | Any Grade 3 or higher TEAE | 0 Participants |
| Ruxolitinib Cream 0.15% QD | Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE From Week 24 to Week 52 | Any TEAE | 6 Participants |
| Ruxolitinib Cream 0.5% QD | Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE From Week 24 to Week 52 | Any TEAE | 5 Participants |
| Ruxolitinib Cream 0.5% QD | Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE From Week 24 to Week 52 | Any Grade 3 or higher TEAE | 0 Participants |
| Ruxolitinib Cream 1.5% QD | Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE From Week 24 to Week 52 | Any TEAE | 9 Participants |
| Ruxolitinib Cream 1.5% QD | Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE From Week 24 to Week 52 | Any Grade 3 or higher TEAE | 0 Participants |
Secondary
Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE From Week 52 to Week 156
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. A TEAE was an AE reported for the first time or the worsening of a pre-existing event after first application of study drug. The severity of AEs was assessed using CTCAE v4.03 Grades 1 through 4. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent intervention indicated.
Time frame: Week 52 to Week 156
Population: Open-label Evaluable Population: all randomized participants who received at least 1 dose of study drug in the Open-label Period
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vehicle Twice Daily (BID) | Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE From Week 52 to Week 156 | Any TEAE | 15 Participants |
| Vehicle Twice Daily (BID) | Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE From Week 52 to Week 156 | Any Grade 3 or higher TEAE | 0 Participants |
| Ruxolitinib Cream 0.15% QD | Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE From Week 52 to Week 156 | Any Grade 3 or higher TEAE | 2 Participants |
| Ruxolitinib Cream 0.15% QD | Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE From Week 52 to Week 156 | Any TEAE | 16 Participants |
| Ruxolitinib Cream 0.5% QD | Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE From Week 52 to Week 156 | Any TEAE | 13 Participants |
| Ruxolitinib Cream 0.5% QD | Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE From Week 52 to Week 156 | Any Grade 3 or higher TEAE | 0 Participants |
| Ruxolitinib Cream 1.5% QD | Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE From Week 52 to Week 156 | Any TEAE | 25 Participants |
| Ruxolitinib Cream 1.5% QD | Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE From Week 52 to Week 156 | Any Grade 3 or higher TEAE | 2 Participants |
Secondary
Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE up to Week 52
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. A TEAE was an AE reported for the first time or the worsening of a pre-existing event after first application of study drug. The severity of AEs was assessed using CTCAE v4.03 Grades 1 through 4. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent intervention indicated.
Time frame: up to 52 weeks
Population: Safety Population. Treatment groups for this population were to be determined according to the actual treatment the participant received on Day 1. Analysis from Day 1 to Week 52 was conducted in participants randomized to receive ruxolitinib cream 0.5% QD, ruxolitinib cream 1.5% QD, or ruxolitinib cream 1.5% BID during the vehicle-controlled period (Day 1 to Week 24).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ruxolitinib Cream 1.5% BID | Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE up to Week 52 | Any TEAE | 26 Participants |
| Ruxolitinib Cream 1.5% BID | Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE up to Week 52 | Any Grade 3 or higher TEAE | 2 Participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE up to Week 52 | Any TEAE | 23 Participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE up to Week 52 | Any Grade 3 or higher TEAE | 1 Participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE up to Week 52 | Any TEAE | 23 Participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE up to Week 52 | Any Grade 3 or higher TEAE | 1 Participants |
Secondary
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Grade 3 or Higher TEAE up to Week 24
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. A TEAE was an AE reported for the first time or the worsening of a pre-existing event after first application of study drug. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grades 1 through 4. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent intervention indicated.
Time frame: up to 24 weeks
Population: Safety Population: all participants who applied at least 1 dose of study drug. Treatment groups for this population were to be determined according to the actual treatment the participant received on Day 1.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vehicle Twice Daily (BID) | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Grade 3 or Higher TEAE up to Week 24 | Any TEAE | 20 Participants |
| Vehicle Twice Daily (BID) | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Grade 3 or Higher TEAE up to Week 24 | Any Grade 3 or higher TEAE | 0 Participants |
| Ruxolitinib Cream 0.15% QD | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Grade 3 or Higher TEAE up to Week 24 | Any TEAE | 20 Participants |
| Ruxolitinib Cream 0.15% QD | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Grade 3 or Higher TEAE up to Week 24 | Any Grade 3 or higher TEAE | 0 Participants |
| Ruxolitinib Cream 0.5% QD | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Grade 3 or Higher TEAE up to Week 24 | Any TEAE | 22 Participants |
| Ruxolitinib Cream 0.5% QD | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Grade 3 or Higher TEAE up to Week 24 | Any Grade 3 or higher TEAE | 0 Participants |
| Ruxolitinib Cream 1.5% QD | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Grade 3 or Higher TEAE up to Week 24 | Any Grade 3 or higher TEAE | 0 Participants |
| Ruxolitinib Cream 1.5% QD | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Grade 3 or Higher TEAE up to Week 24 | Any TEAE | 22 Participants |
| Ruxolitinib Cream 1.5% BID | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Grade 3 or Higher TEAE up to Week 24 | Any TEAE | 20 Participants |
| Ruxolitinib Cream 1.5% BID | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Grade 3 or Higher TEAE up to Week 24 | Any Grade 3 or higher TEAE | 1 Participants |
Secondary
Percentage Change From Baseline in F-BSA Repigmentation at Week 24
F-BSA involvement was the proportion of the facial body surface area with vitiligo. The area Face was defined as including the area on the forehead to the original hairline, on the cheek to the jawline vertically and laterally from the corner of the mouth to the tragus. The area Face did not include the surface area of the lips, scalp, ears, or neck, but included the nose and eyelids. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Percentage change = (\[post-Baseline value minus Baseline value\]/Baseline value) X 100.
Time frame: Baseline; Week 24
Population: ITT Population. Only participants with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle Twice Daily (BID) | Percentage Change From Baseline in F-BSA Repigmentation at Week 24 | 6.49 percent change | Standard Deviation 32.028 |
| Ruxolitinib Cream 0.15% QD | Percentage Change From Baseline in F-BSA Repigmentation at Week 24 | -19.82 percent change | Standard Deviation 24.928 |
| Ruxolitinib Cream 0.5% QD | Percentage Change From Baseline in F-BSA Repigmentation at Week 24 | -17.55 percent change | Standard Deviation 25.453 |
| Ruxolitinib Cream 1.5% QD | Percentage Change From Baseline in F-BSA Repigmentation at Week 24 | -19.53 percent change | Standard Deviation 38.612 |
| Ruxolitinib Cream 1.5% BID | Percentage Change From Baseline in F-BSA Repigmentation at Week 24 | -27.76 percent change | Standard Deviation 30.996 |
Secondary
Percentage Change From Baseline in F-BSA Repigmentation at Weeks 52, 104, and 156
F-BSA involvement was the proportion of the facial body surface area with vitiligo. The area Face was defined as including the area on the forehead to the original hairline, on the cheek to the jawline vertically and laterally from the corner of the mouth to the tragus. The area Face did not include the surface area of the lips, scalp, ears, or neck, but included the nose and eyelids. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Percentage change = (\[post-Baseline value minus Baseline value\]/Baseline value) X 100.
Time frame: Baseline; Weeks 52, 104, and 156
Population: ITT Population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle Twice Daily (BID) | Percentage Change From Baseline in F-BSA Repigmentation at Weeks 52, 104, and 156 | Week 156 | -33.04 percent change | Standard Deviation 6.313 |
| Vehicle Twice Daily (BID) | Percentage Change From Baseline in F-BSA Repigmentation at Weeks 52, 104, and 156 | Week 104 | -42.86 percent change | Standard Deviation 31.282 |
| Vehicle Twice Daily (BID) | Percentage Change From Baseline in F-BSA Repigmentation at Weeks 52, 104, and 156 | Week 52 | -55.18 percent change | Standard Deviation 36.091 |
| Ruxolitinib Cream 0.15% QD | Percentage Change From Baseline in F-BSA Repigmentation at Weeks 52, 104, and 156 | Week 104 | -67.61 percent change | Standard Deviation 29.683 |
| Ruxolitinib Cream 0.15% QD | Percentage Change From Baseline in F-BSA Repigmentation at Weeks 52, 104, and 156 | Week 52 | -37.94 percent change | Standard Deviation 32.569 |
| Ruxolitinib Cream 0.15% QD | Percentage Change From Baseline in F-BSA Repigmentation at Weeks 52, 104, and 156 | Week 156 | -59.17 percent change | Standard Deviation 40.586 |
| Ruxolitinib Cream 0.5% QD | Percentage Change From Baseline in F-BSA Repigmentation at Weeks 52, 104, and 156 | Week 156 | -90.50 percent change | Standard Deviation 16.24 |
| Ruxolitinib Cream 0.5% QD | Percentage Change From Baseline in F-BSA Repigmentation at Weeks 52, 104, and 156 | Week 52 | -33.39 percent change | Standard Deviation 40.095 |
| Ruxolitinib Cream 0.5% QD | Percentage Change From Baseline in F-BSA Repigmentation at Weeks 52, 104, and 156 | Week 104 | -76.57 percent change | Standard Deviation 31.26 |
| Ruxolitinib Cream 1.5% QD | Percentage Change From Baseline in F-BSA Repigmentation at Weeks 52, 104, and 156 | Week 104 | -45.65 percent change | Standard Deviation 59.599 |
| Ruxolitinib Cream 1.5% QD | Percentage Change From Baseline in F-BSA Repigmentation at Weeks 52, 104, and 156 | Week 52 | -15.64 percent change | Standard Deviation 29.733 |
| Ruxolitinib Cream 1.5% QD | Percentage Change From Baseline in F-BSA Repigmentation at Weeks 52, 104, and 156 | Week 156 | -16.89 percent change | Standard Deviation 56.706 |
| Ruxolitinib Cream 1.5% BID | Percentage Change From Baseline in F-BSA Repigmentation at Weeks 52, 104, and 156 | Week 104 | -54.49 percent change | Standard Deviation 34.411 |
| Ruxolitinib Cream 1.5% BID | Percentage Change From Baseline in F-BSA Repigmentation at Weeks 52, 104, and 156 | Week 52 | -34.67 percent change | Standard Deviation 37.769 |
| Ruxolitinib Cream 1.5% BID | Percentage Change From Baseline in F-BSA Repigmentation at Weeks 52, 104, and 156 | Week 156 | -55.80 percent change | Standard Deviation 33.31 |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage Change From Baseline in F-BSA Repigmentation at Weeks 52, 104, and 156 | Week 52 | -38.37 percent change | Standard Deviation 38.66 |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage Change From Baseline in F-BSA Repigmentation at Weeks 52, 104, and 156 | Week 156 | -59.58 percent change | Standard Deviation 27.106 |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage Change From Baseline in F-BSA Repigmentation at Weeks 52, 104, and 156 | Week 104 | -63.56 percent change | Standard Deviation 28.543 |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage Change From Baseline in F-BSA Repigmentation at Weeks 52, 104, and 156 | Week 156 | -72.58 percent change | Standard Deviation 31.024 |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage Change From Baseline in F-BSA Repigmentation at Weeks 52, 104, and 156 | Week 104 | -59.49 percent change | Standard Deviation 38.186 |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage Change From Baseline in F-BSA Repigmentation at Weeks 52, 104, and 156 | Week 52 | -44.29 percent change | Standard Deviation 35.253 |
Secondary
Percentage Change From Baseline in F-VASI Score at Week 24
F-VASI was measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement). Percentage change = (\[post-Baseline value minus Baseline value\]/Baseline value) X 100.
Time frame: Baseline; Week 24
Population: ITT Population. Only participants with available data were analyzed. MMRM model for post-Baseline measures: (response variable = treatment + stratification factor \[age ≤30 versus \>30\] + visit + treatment\*visit). All post-Baseline visits up to Week 24 were included in the model.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Vehicle Twice Daily (BID) | Percentage Change From Baseline in F-VASI Score at Week 24 | 6.02 percent change | Standard Error 7.23 |
| Ruxolitinib Cream 0.15% QD | Percentage Change From Baseline in F-VASI Score at Week 24 | -30.69 percent change | Standard Error 7.39 |
| Ruxolitinib Cream 0.5% QD | Percentage Change From Baseline in F-VASI Score at Week 24 | -29.10 percent change | Standard Error 6.93 |
| Ruxolitinib Cream 1.5% QD | Percentage Change From Baseline in F-VASI Score at Week 24 | -40.00 percent change | Standard Error 7.39 |
| Ruxolitinib Cream 1.5% BID | Percentage Change From Baseline in F-VASI Score at Week 24 | -37.78 percent change | Standard Error 6.89 |
p-value: 0.000595% CI: [-57.15, -16.27]Log Rank
p-value: 0.000695% CI: [-54.91, -15.33]Log Rank
p-value: <0.000195% CI: [-66.47, -25.57]Log Rank
p-value: <0.000195% CI: [-63.52, -24.07]Log Rank
Secondary
Percentage Change From Baseline in F-VASI Score at Weeks 52, 104, and 156
F-VASI was measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement). Percentage change = (\[post-Baseline value minus Baseline value\]/Baseline value) X 100.
Time frame: Baseline; Weeks 52, 104, and 156
Population: ITT Population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle Twice Daily (BID) | Percentage Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Week 156 | -87.95 percent change | Standard Deviation 8.207 |
| Vehicle Twice Daily (BID) | Percentage Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Week 104 | -77.67 percent change | Standard Deviation 22.974 |
| Vehicle Twice Daily (BID) | Percentage Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Week 52 | -72.21 percent change | Standard Deviation 26.837 |
| Ruxolitinib Cream 0.15% QD | Percentage Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Week 104 | -71.12 percent change | Standard Deviation 31.087 |
| Ruxolitinib Cream 0.15% QD | Percentage Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Week 52 | -50.60 percent change | Standard Deviation 34.954 |
| Ruxolitinib Cream 0.15% QD | Percentage Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Week 156 | -66.83 percent change | Standard Deviation 45.106 |
| Ruxolitinib Cream 0.5% QD | Percentage Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Week 156 | -91.25 percent change | Standard Deviation 14.631 |
| Ruxolitinib Cream 0.5% QD | Percentage Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Week 52 | -52.43 percent change | Standard Deviation 36.412 |
| Ruxolitinib Cream 0.5% QD | Percentage Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Week 104 | -82.87 percent change | Standard Deviation 32.756 |
| Ruxolitinib Cream 1.5% QD | Percentage Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Week 104 | -60.28 percent change | Standard Deviation 64.708 |
| Ruxolitinib Cream 1.5% QD | Percentage Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Week 52 | -40.79 percent change | Standard Deviation 37.082 |
| Ruxolitinib Cream 1.5% QD | Percentage Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Week 156 | -59.16 percent change | Standard Deviation 42.627 |
| Ruxolitinib Cream 1.5% BID | Percentage Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Week 104 | -74.89 percent change | Standard Deviation 25.524 |
| Ruxolitinib Cream 1.5% BID | Percentage Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Week 52 | -45.54 percent change | Standard Deviation 35.148 |
| Ruxolitinib Cream 1.5% BID | Percentage Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Week 156 | -76.25 percent change | Standard Deviation 20.126 |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Week 52 | -55.63 percent change | Standard Deviation 42.823 |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Week 156 | -76.76 percent change | Standard Deviation 23.924 |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Week 104 | -77.76 percent change | Standard Deviation 24.086 |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Week 156 | -89.52 percent change | Standard Deviation 14.899 |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Week 104 | -78.78 percent change | Standard Deviation 28.4 |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Week 52 | -57.34 percent change | Standard Deviation 50.115 |
Secondary
Percentage Change From Baseline in T-BSA Repigmentation at Week 24
T-BSA involvement was the proportion of the body surface area with vitiligo. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Percentage change = (\[post-Baseline value minus Baseline value\]/Baseline value) X 100.
Time frame: Baseline; Week 24
Population: ITT Population. Only participants with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle Twice Daily (BID) | Percentage Change From Baseline in T-BSA Repigmentation at Week 24 | 3.35 percent change | Standard Deviation 8.314 |
| Ruxolitinib Cream 0.15% QD | Percentage Change From Baseline in T-BSA Repigmentation at Week 24 | -13.97 percent change | Standard Deviation 25.396 |
| Ruxolitinib Cream 0.5% QD | Percentage Change From Baseline in T-BSA Repigmentation at Week 24 | -10.83 percent change | Standard Deviation 15.646 |
| Ruxolitinib Cream 1.5% QD | Percentage Change From Baseline in T-BSA Repigmentation at Week 24 | -17.19 percent change | Standard Deviation 22.49 |
| Ruxolitinib Cream 1.5% BID | Percentage Change From Baseline in T-BSA Repigmentation at Week 24 | -13.60 percent change | Standard Deviation 20.443 |
Secondary
Percentage Change From Baseline in T-BSA Repigmentation at Weeks 52, 104, and 156
T-BSA involvement was the proportion of the body surface area with vitiligo. Body surface area assessment was performed by the Palmar Method. Body surface area was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Percentage change = (\[post-Baseline value minus Baseline value\]/Baseline value) X 100.
Time frame: Baseline; Weeks 52, 104, and 156
Population: ITT Population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle Twice Daily (BID) | Percentage Change From Baseline in T-BSA Repigmentation at Weeks 52, 104, and 156 | Week 156 | -59.44 percent change | Standard Deviation 51.92 |
| Vehicle Twice Daily (BID) | Percentage Change From Baseline in T-BSA Repigmentation at Weeks 52, 104, and 156 | Week 104 | -42.42 percent change | Standard Deviation 32.208 |
| Vehicle Twice Daily (BID) | Percentage Change From Baseline in T-BSA Repigmentation at Weeks 52, 104, and 156 | Week 52 | -39.53 percent change | Standard Deviation 32.599 |
| Ruxolitinib Cream 0.15% QD | Percentage Change From Baseline in T-BSA Repigmentation at Weeks 52, 104, and 156 | Week 104 | -30.49 percent change | Standard Deviation 36.289 |
| Ruxolitinib Cream 0.15% QD | Percentage Change From Baseline in T-BSA Repigmentation at Weeks 52, 104, and 156 | Week 52 | -8.72 percent change | Standard Deviation 26.01 |
| Ruxolitinib Cream 0.15% QD | Percentage Change From Baseline in T-BSA Repigmentation at Weeks 52, 104, and 156 | Week 156 | -46.58 percent change | Standard Deviation 30.723 |
| Ruxolitinib Cream 0.5% QD | Percentage Change From Baseline in T-BSA Repigmentation at Weeks 52, 104, and 156 | Week 156 | -34.93 percent change | Standard Deviation 35.391 |
| Ruxolitinib Cream 0.5% QD | Percentage Change From Baseline in T-BSA Repigmentation at Weeks 52, 104, and 156 | Week 52 | -2.72 percent change | Standard Deviation 23.014 |
| Ruxolitinib Cream 0.5% QD | Percentage Change From Baseline in T-BSA Repigmentation at Weeks 52, 104, and 156 | Week 104 | -30.08 percent change | Standard Deviation 30.717 |
| Ruxolitinib Cream 1.5% QD | Percentage Change From Baseline in T-BSA Repigmentation at Weeks 52, 104, and 156 | Week 104 | -21.08 percent change | Standard Deviation 30.323 |
| Ruxolitinib Cream 1.5% QD | Percentage Change From Baseline in T-BSA Repigmentation at Weeks 52, 104, and 156 | Week 52 | -8.73 percent change | Standard Deviation 21.63 |
| Ruxolitinib Cream 1.5% QD | Percentage Change From Baseline in T-BSA Repigmentation at Weeks 52, 104, and 156 | Week 156 | -37.95 percent change | Standard Deviation 23.651 |
| Ruxolitinib Cream 1.5% BID | Percentage Change From Baseline in T-BSA Repigmentation at Weeks 52, 104, and 156 | Week 104 | -33.19 percent change | Standard Deviation 30.127 |
| Ruxolitinib Cream 1.5% BID | Percentage Change From Baseline in T-BSA Repigmentation at Weeks 52, 104, and 156 | Week 52 | -15.13 percent change | Standard Deviation 21.296 |
| Ruxolitinib Cream 1.5% BID | Percentage Change From Baseline in T-BSA Repigmentation at Weeks 52, 104, and 156 | Week 156 | -29.59 percent change | Standard Deviation 32.261 |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage Change From Baseline in T-BSA Repigmentation at Weeks 52, 104, and 156 | Week 52 | -27.33 percent change | Standard Deviation 27.568 |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage Change From Baseline in T-BSA Repigmentation at Weeks 52, 104, and 156 | Week 156 | -10.55 percent change | Standard Deviation 53.863 |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage Change From Baseline in T-BSA Repigmentation at Weeks 52, 104, and 156 | Week 104 | -33.94 percent change | Standard Deviation 26.573 |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage Change From Baseline in T-BSA Repigmentation at Weeks 52, 104, and 156 | Week 156 | -46.88 percent change | Standard Deviation 19.304 |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage Change From Baseline in T-BSA Repigmentation at Weeks 52, 104, and 156 | Week 104 | -32.46 percent change | Standard Deviation 33.19 |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage Change From Baseline in T-BSA Repigmentation at Weeks 52, 104, and 156 | Week 52 | -27.59 percent change | Standard Deviation 26.77 |
Secondary
Percentage Change From Baseline in T-VASI Score at Week 24
T-VASI was calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement).
Time frame: Baseline; Week 24
Population: ITT Population. Only participants with available data were analyzed. Percentage change = (\[post-Baseline value minus Baseline value\]/Baseline value) X 100. MMRM model for post-Baseline measures: (response variable = treatment + stratification factor \[age ≤30 versus \>30\] + visit + treatment\*visit). All post-Baseline visits up to Week 24 were included in the model.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Vehicle Twice Daily (BID) | Percentage Change From Baseline in T-VASI Score at Week 24 | 2.65 percent change | Standard Error 4.89 |
| Ruxolitinib Cream 0.15% QD | Percentage Change From Baseline in T-VASI Score at Week 24 | -20.88 percent change | Standard Error 5 |
| Ruxolitinib Cream 0.5% QD | Percentage Change From Baseline in T-VASI Score at Week 24 | -15.82 percent change | Standard Error 4.69 |
| Ruxolitinib Cream 1.5% QD | Percentage Change From Baseline in T-VASI Score at Week 24 | -27.16 percent change | Standard Error 4.99 |
| Ruxolitinib Cream 1.5% BID | Percentage Change From Baseline in T-VASI Score at Week 24 | -22.91 percent change | Standard Error 4.65 |
p-value: 0.00195% CI: [-37.35, -9.71]Log Rank
p-value: 0.007295% CI: [-31.86, -5.08]Log Rank
p-value: <0.000195% CI: [-43.61, -16]Log Rank
p-value: 0.000295% CI: [-38.89, -12.22]Log Rank
Secondary
Percentage Change From Baseline in T-VASI Score at Weeks 52, 104, and 156
T-VASI was calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement).
Time frame: Baseline; Weeks 52, 104, and 156
Population: ITT Population. Only participants with available data were analyzed. Percentage change = (\[post-Baseline value minus Baseline value\]/Baseline value) X 100.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle Twice Daily (BID) | Percentage Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Week 156 | -71.10 percent change | Standard Deviation 31.448 |
| Vehicle Twice Daily (BID) | Percentage Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Week 104 | -60.96 percent change | Standard Deviation 32.259 |
| Vehicle Twice Daily (BID) | Percentage Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Week 52 | -50.71 percent change | Standard Deviation 33.31 |
| Ruxolitinib Cream 0.15% QD | Percentage Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Week 156 | -59.33 percent change | Standard Deviation 40.055 |
| Ruxolitinib Cream 0.15% QD | Percentage Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Week 52 | -25.12 percent change | Standard Deviation 31.556 |
| Ruxolitinib Cream 0.15% QD | Percentage Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Week 104 | -49.35 percent change | Standard Deviation 39.319 |
| Ruxolitinib Cream 0.5% QD | Percentage Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Week 52 | -19.75 percent change | Standard Deviation 26.484 |
| Ruxolitinib Cream 0.5% QD | Percentage Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Week 156 | -47.31 percent change | Standard Deviation 34.61 |
| Ruxolitinib Cream 0.5% QD | Percentage Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Week 104 | -49.07 percent change | Standard Deviation 29.091 |
| Ruxolitinib Cream 1.5% QD | Percentage Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Week 104 | -38.70 percent change | Standard Deviation 38.663 |
| Ruxolitinib Cream 1.5% QD | Percentage Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Week 52 | -20.00 percent change | Standard Deviation 29.264 |
| Ruxolitinib Cream 1.5% QD | Percentage Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Week 156 | -49.96 percent change | Standard Deviation 27.555 |
| Ruxolitinib Cream 1.5% BID | Percentage Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Week 156 | -44.69 percent change | Standard Deviation 30.718 |
| Ruxolitinib Cream 1.5% BID | Percentage Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Week 52 | -24.67 percent change | Standard Deviation 29.649 |
| Ruxolitinib Cream 1.5% BID | Percentage Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Week 104 | -46.44 percent change | Standard Deviation 31.668 |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Week 104 | -52.14 percent change | Standard Deviation 33.559 |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Week 52 | -41.90 percent change | Standard Deviation 35.865 |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Week 156 | -14.97 percent change | Standard Deviation 58.982 |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Week 104 | -50.03 percent change | Standard Deviation 26.905 |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Week 52 | -41.67 percent change | Standard Deviation 26.451 |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Week 156 | -62.80 percent change | Standard Deviation 20.904 |
Secondary
Percentage Change From Baseline in VETF Scale Scores at Week 24: Total Percentage Area
The VETF-proposed system combines analysis of extent (0%-100% BSA), stage of disease (staging), and disease progression (spreading); each component is evaluated and reported independently. Staging is based on cutaneous and hair pigmentation in vitiligo patches. Disease is staged 0 to 4 on the largest macule in each of 5 body regions, except hands and feet, which are assessed separately and globally as 1 unique area. Stage 0=normal pigmentation, Stage 1=incomplete pigmentation, Stage 2=complete depigmentation (a few white hairs do not change stage), Stage 3=partial hair whitening (\<30%), Stage 4=complete hair whitening; total score of 0 (less severe disease) to 20 (more severe disease). Disease progression is based on assessing the largest patch in each of 5 body areas: -1=regressive vitiligo (ongoing subclinical repigmentation), 0=similar limits, 1=progressive vitiligo (ongoing subclinical depigmentation); total score of -5 (improving disease) to +5 (more severe disease spread).
Time frame: Baseline; Week 24
Population: ITT Population. Only participants with available data were analyzed. Percentage change = (\[post-Baseline value minus Baseline value\]/Baseline value) X 100.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle Twice Daily (BID) | Percentage Change From Baseline in VETF Scale Scores at Week 24: Total Percentage Area | 2.61 percent change | Standard Deviation 9.497 |
| Ruxolitinib Cream 0.15% QD | Percentage Change From Baseline in VETF Scale Scores at Week 24: Total Percentage Area | -10.61 percent change | Standard Deviation 29.408 |
| Ruxolitinib Cream 0.5% QD | Percentage Change From Baseline in VETF Scale Scores at Week 24: Total Percentage Area | -13.87 percent change | Standard Deviation 25.296 |
| Ruxolitinib Cream 1.5% QD | Percentage Change From Baseline in VETF Scale Scores at Week 24: Total Percentage Area | -14.09 percent change | Standard Deviation 20.321 |
| Ruxolitinib Cream 1.5% BID | Percentage Change From Baseline in VETF Scale Scores at Week 24: Total Percentage Area | -13.10 percent change | Standard Deviation 17.605 |
Secondary
Percentage Change From Baseline in VETF Scale Scores at Week 24: Total Staging
The VETF-proposed system combines analysis of extent (0%-100% BSA), stage of disease (staging), and disease progression (spreading); each component is evaluated and reported independently. Staging is based on cutaneous and hair pigmentation in vitiligo patches. Disease is staged 0 to 4 on the largest macule in each of 5 body regions, except hands and feet, which are assessed separately and globally as 1 unique area. Stage 0=normal pigmentation, Stage 1=incomplete pigmentation, Stage 2=complete depigmentation (a few white hairs do not change stage), Stage 3=partial hair whitening (\<30%), Stage 4=complete hair whitening; total score of 0 (less severe disease) to 20 (more severe disease). Disease progression is based on assessing the largest patch in each of 5 body areas: -1=regressive vitiligo (ongoing subclinical repigmentation), 0=similar limits, 1=progressive vitiligo (ongoing subclinical depigmentation); total score of -5 (improving disease) to +5 (more severe disease spread).
Time frame: Baseline; Week 24
Population: ITT Population. Only participants with available data were analyzed. Percentage change = (\[post-Baseline value minus Baseline value\]/Baseline value) X 100.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle Twice Daily (BID) | Percentage Change From Baseline in VETF Scale Scores at Week 24: Total Staging | -7.58 percent change | Standard Deviation 18.74 |
| Ruxolitinib Cream 0.15% QD | Percentage Change From Baseline in VETF Scale Scores at Week 24: Total Staging | -17.52 percent change | Standard Deviation 22.267 |
| Ruxolitinib Cream 0.5% QD | Percentage Change From Baseline in VETF Scale Scores at Week 24: Total Staging | -13.55 percent change | Standard Deviation 21.2 |
| Ruxolitinib Cream 1.5% QD | Percentage Change From Baseline in VETF Scale Scores at Week 24: Total Staging | -17.00 percent change | Standard Deviation 31.798 |
| Ruxolitinib Cream 1.5% BID | Percentage Change From Baseline in VETF Scale Scores at Week 24: Total Staging | -4.46 percent change | Standard Deviation 38.916 |
Secondary
Percentage Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Percentage Area
The VETF-proposed system combines analysis of extent (0%-100% BSA), stage of disease (staging), and disease progression (spreading); each component is evaluated and reported independently. Staging is based on cutaneous and hair pigmentation in vitiligo patches. Disease is staged 0 to 4 on the largest macule in each of 5 body regions, except hands and feet, which are assessed separately and globally as 1 unique area. Stage 0=normal pigmentation, Stage 1=incomplete pigmentation, Stage 2=complete depigmentation (a few white hairs do not change stage), Stage 3=partial hair whitening (\<30%), Stage 4=complete hair whitening; total score of 0 (less severe disease) to 20 (more severe disease). Disease progression is based on assessing the largest patch in each of 5 body areas: -1=regressive vitiligo (ongoing subclinical repigmentation), 0=similar limits, 1=progressive vitiligo (ongoing subclinical depigmentation); total score of -5 (improving disease) to +5 (more severe disease spread).
Time frame: Baseline; Weeks 52 and 104
Population: ITT Population. Only participants with available data were analyzed. Percentage change = (\[post-Baseline value minus Baseline value\]/Baseline value) X 100.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle Twice Daily (BID) | Percentage Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Percentage Area | Week 52 | -32.01 percent change | Standard Deviation 35.629 |
| Vehicle Twice Daily (BID) | Percentage Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Percentage Area | Week 104 | -39.30 percent change | Standard Deviation 37.071 |
| Ruxolitinib Cream 0.15% QD | Percentage Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Percentage Area | Week 52 | -7.39 percent change | Standard Deviation 21.571 |
| Ruxolitinib Cream 0.15% QD | Percentage Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Percentage Area | Week 104 | -23.05 percent change | Standard Deviation 29.233 |
| Ruxolitinib Cream 0.5% QD | Percentage Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Percentage Area | Week 52 | -10.57 percent change | Standard Deviation 22.3 |
| Ruxolitinib Cream 0.5% QD | Percentage Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Percentage Area | Week 104 | -34.03 percent change | Standard Deviation 27.992 |
| Ruxolitinib Cream 1.5% QD | Percentage Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Percentage Area | Week 52 | -7.13 percent change | Standard Deviation 25.967 |
| Ruxolitinib Cream 1.5% QD | Percentage Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Percentage Area | Week 104 | -18.49 percent change | Standard Deviation 36.527 |
| Ruxolitinib Cream 1.5% BID | Percentage Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Percentage Area | Week 52 | -19.73 percent change | Standard Deviation 30.73 |
| Ruxolitinib Cream 1.5% BID | Percentage Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Percentage Area | Week 104 | -35.55 percent change | Standard Deviation 34.039 |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Percentage Area | Week 52 | -22.36 percent change | Standard Deviation 23.593 |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Percentage Area | Week 104 | -30.40 percent change | Standard Deviation 22.94 |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Percentage Area | Week 52 | -25.41 percent change | Standard Deviation 24.049 |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Percentage Area | Week 104 | -29.19 percent change | Standard Deviation 39.767 |
Secondary
Percentage Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Staging
The VETF-proposed system combines analysis of extent (0%-100% BSA), stage of disease (staging), and disease progression (spreading); each component is evaluated and reported independently. Staging is based on cutaneous and hair pigmentation in vitiligo patches. Disease is staged 0 to 4 on the largest macule in each of 5 body regions, except hands and feet, which are assessed separately and globally as 1 unique area. Stage 0=normal pigmentation, Stage 1=incomplete pigmentation, Stage 2=complete depigmentation (a few white hairs do not change stage), Stage 3=partial hair whitening (\<30%), Stage 4=complete hair whitening; total score of 0 (less severe disease) to 20 (more severe disease). Disease progression is based on assessing the largest patch in each of 5 body areas: -1=regressive vitiligo (ongoing subclinical repigmentation), 0=similar limits, 1=progressive vitiligo (ongoing subclinical depigmentation); total score of -5 (improving disease) to +5 (more severe disease spread).
Time frame: Baseline; Weeks 52 and 104
Population: ITT Population. Only participants with available data were analyzed. Percentage change = (\[post-Baseline value minus Baseline value\]/Baseline value) X 100.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle Twice Daily (BID) | Percentage Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Staging | Week 52 | -33.48 percent change | Standard Deviation 25.022 |
| Vehicle Twice Daily (BID) | Percentage Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Staging | Week 104 | -37.20 percent change | Standard Deviation 29.132 |
| Ruxolitinib Cream 0.15% QD | Percentage Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Staging | Week 52 | -12.70 percent change | Standard Deviation 24.012 |
| Ruxolitinib Cream 0.15% QD | Percentage Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Staging | Week 104 | -24.29 percent change | Standard Deviation 30.439 |
| Ruxolitinib Cream 0.5% QD | Percentage Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Staging | Week 52 | -17.31 percent change | Standard Deviation 22.623 |
| Ruxolitinib Cream 0.5% QD | Percentage Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Staging | Week 104 | -16.55 percent change | Standard Deviation 27.268 |
| Ruxolitinib Cream 1.5% QD | Percentage Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Staging | Week 52 | -23.88 percent change | Standard Deviation 19.262 |
| Ruxolitinib Cream 1.5% QD | Percentage Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Staging | Week 104 | -32.06 percent change | Standard Deviation 12.311 |
| Ruxolitinib Cream 1.5% BID | Percentage Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Staging | Week 52 | -21.45 percent change | Standard Deviation 24.571 |
| Ruxolitinib Cream 1.5% BID | Percentage Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Staging | Week 104 | -27.76 percent change | Standard Deviation 23.202 |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Staging | Week 52 | -30.00 percent change | Standard Deviation 22.563 |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Staging | Week 104 | -35.20 percent change | Standard Deviation 23.904 |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Staging | Week 52 | -12.99 percent change | Standard Deviation 29.585 |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Staging | Week 104 | -14.09 percent change | Standard Deviation 26.969 |
Secondary
Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156
The severity of vitiligo was assessed by the participant using the PaGVA, which has a 5-point scale. The participant was asked the following: How severe is your vitiligo on your face (or total body) with respect to the area covered by white skin? Responses: 0=no white patches (no vitiligo); 1=mild; 2=moderate; 3=severe; 4=very severe.
Time frame: Weeks 52, 104, and 156
Population: ITT Population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 2 | 22.2 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 4 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 1 | 50.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 1 | 50.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 4 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 2 | 50.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 3 | 10.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 0 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 1 | 66.7 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 4 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 0 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 0 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 3 | 11.1 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 3 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 2 | 40.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 2 | 37.5 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 3 | 12.5 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 1 | 21.4 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 3 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 2 | 28.6 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 2 | 50.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 3 | 50.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 1 | 50.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 1 | 50.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 1 | 22.2 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 0 | 20.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 2 | 55.6 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 3 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 3 | 22.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 3 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 1 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 1 | 16.7 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 2 | 80.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 2 | 83.3 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 2 | 33.3 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 1 | 30.8 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 2 | 46.2 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 3 | 23.1 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 1 | 55.6 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 3 | 11.1 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 1 | 80.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 2 | 20.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 3 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 2 | 36.8 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 1 | 24.1 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 2 | 50.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 3 | 34.5 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 1 | 37.5 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 1 | 42.1 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 2 | 37.9 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 3 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 3 | 15.8 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 0 | 5.3 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 4 | 3.4 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 0 | 12.5 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 4 | 12.5 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 3 | 22.2 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 0 | 5.6 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 4 | 11.1 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 4 | 10.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 3 | 30.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 1 | 37.5 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 2 | 30.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 2 | 50.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 1 | 30.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 3 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 2 | 16.7 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 1 | 44.4 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 2 | 22.2 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 1 | 44.8 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 1 | 36.8 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 0 | 11.1 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 4 | 6.9 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 4 | 5.3 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 0 | 3.4 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 3 | 11.1 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 0 | 5.3 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 2 | 24.1 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 3 | 5.3 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 1 | 44.4 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 4 | 11.1 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 3 | 20.7 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 2 | 47.4 percentage of participants |
Secondary
Percentage of Participants in Each Facial Assessment of the Patient's Global Vitiligo Assessment (F-PaGVA) Category at Week 24
The severity of vitiligo was assessed by the participant using the PaGVA, which has a 5-point scale. The participant was asked the following: How severe is your vitiligo on your face (or total body) with respect to the area covered by white skin? Responses: 0=no white patches (no vitiligo); 1=mild; 2=moderate; 3=severe; 4=very severe.
Time frame: Week 24
Population: ITT Population. Missing post-Baseline values were considered as not having achieved F-PaGVA response for visits up to Week 24.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Facial Assessment of the Patient's Global Vitiligo Assessment (F-PaGVA) Category at Week 24 | 0 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Facial Assessment of the Patient's Global Vitiligo Assessment (F-PaGVA) Category at Week 24 | 1 | 9.4 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Facial Assessment of the Patient's Global Vitiligo Assessment (F-PaGVA) Category at Week 24 | 2 | 31.3 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Facial Assessment of the Patient's Global Vitiligo Assessment (F-PaGVA) Category at Week 24 | 3 | 28.1 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Facial Assessment of the Patient's Global Vitiligo Assessment (F-PaGVA) Category at Week 24 | 4 | 15.6 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Facial Assessment of the Patient's Global Vitiligo Assessment (F-PaGVA) Category at Week 24 | Missing at the visit | 15.6 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Facial Assessment of the Patient's Global Vitiligo Assessment (F-PaGVA) Category at Week 24 | 4 | 3.2 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Facial Assessment of the Patient's Global Vitiligo Assessment (F-PaGVA) Category at Week 24 | Missing at the visit | 16.1 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Facial Assessment of the Patient's Global Vitiligo Assessment (F-PaGVA) Category at Week 24 | 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Facial Assessment of the Patient's Global Vitiligo Assessment (F-PaGVA) Category at Week 24 | 2 | 38.7 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Facial Assessment of the Patient's Global Vitiligo Assessment (F-PaGVA) Category at Week 24 | 3 | 25.8 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Facial Assessment of the Patient's Global Vitiligo Assessment (F-PaGVA) Category at Week 24 | 1 | 16.1 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Facial Assessment of the Patient's Global Vitiligo Assessment (F-PaGVA) Category at Week 24 | 3 | 35.5 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Facial Assessment of the Patient's Global Vitiligo Assessment (F-PaGVA) Category at Week 24 | 4 | 6.5 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Facial Assessment of the Patient's Global Vitiligo Assessment (F-PaGVA) Category at Week 24 | 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Facial Assessment of the Patient's Global Vitiligo Assessment (F-PaGVA) Category at Week 24 | 2 | 41.9 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Facial Assessment of the Patient's Global Vitiligo Assessment (F-PaGVA) Category at Week 24 | 1 | 12.9 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Facial Assessment of the Patient's Global Vitiligo Assessment (F-PaGVA) Category at Week 24 | Missing at the visit | 3.2 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Facial Assessment of the Patient's Global Vitiligo Assessment (F-PaGVA) Category at Week 24 | 3 | 20.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Facial Assessment of the Patient's Global Vitiligo Assessment (F-PaGVA) Category at Week 24 | 1 | 16.7 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Facial Assessment of the Patient's Global Vitiligo Assessment (F-PaGVA) Category at Week 24 | 2 | 40.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Facial Assessment of the Patient's Global Vitiligo Assessment (F-PaGVA) Category at Week 24 | Missing at the visit | 13.3 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Facial Assessment of the Patient's Global Vitiligo Assessment (F-PaGVA) Category at Week 24 | 4 | 10.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Facial Assessment of the Patient's Global Vitiligo Assessment (F-PaGVA) Category at Week 24 | 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Facial Assessment of the Patient's Global Vitiligo Assessment (F-PaGVA) Category at Week 24 | 4 | 9.1 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Facial Assessment of the Patient's Global Vitiligo Assessment (F-PaGVA) Category at Week 24 | 2 | 27.3 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Facial Assessment of the Patient's Global Vitiligo Assessment (F-PaGVA) Category at Week 24 | 1 | 33.3 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Facial Assessment of the Patient's Global Vitiligo Assessment (F-PaGVA) Category at Week 24 | Missing at the visit | 6.1 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Facial Assessment of the Patient's Global Vitiligo Assessment (F-PaGVA) Category at Week 24 | 3 | 24.2 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Facial Assessment of the Patient's Global Vitiligo Assessment (F-PaGVA) Category at Week 24 | 0 | 0.0 percentage of participants |
Secondary
Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156
The severity of vitiligo was assessed by the physician using the PhGVA, which has a 5-point scale. 0=clear, no signs of vitiligo; 1=almost clear, only specks of depigmentation present; 2=mild disease, pigmented and depigmented areas are equal; 3=moderate disease, more or complete depigmentation (may include \< 30% hair whitening); 4=severe disease, complete depigmentation plus \> 30% hair whitening.
Time frame: Weeks 52, 104, and 156
Population: ITT Population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 2 | 33.3 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 4 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 1 | 20.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 1 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 4 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 2 | 100.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 3 | 20.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 0 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 1 | 55.6 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 4 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 0 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 0 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 3 | 11.1 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 3 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 2 | 60.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 2 | 25.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 3 | 25.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 1 | 14.3 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 3 | 50.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 2 | 7.1 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 2 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 3 | 71.4 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 1 | 50.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 4 | 7.1 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 1 | 50.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 4 | 8.3 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 1 | 33.3 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 0 | 60.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 2 | 33.3 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 3 | 20.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 3 | 11.1 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 0 | 11.1 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 3 | 50.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 1 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 1 | 8.3 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 2 | 20.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 2 | 33.3 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 4 | 11.1 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 2 | 22.2 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 1 | 7.7 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 2 | 46.2 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 3 | 46.2 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 0 | 11.1 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 1 | 22.2 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 3 | 44.4 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 1 | 60.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 2 | 20.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 3 | 20.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 2 | 36.8 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 1 | 10.3 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 2 | 50.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 3 | 55.2 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 1 | 12.5 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 1 | 31.6 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 2 | 17.2 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 3 | 12.5 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 3 | 26.3 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 0 | 5.3 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 4 | 10.3 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 0 | 6.9 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 0 | 25.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 3 | 27.8 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 0 | 11.1 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 0 | 4.8 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 4 | 9.5 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 3 | 42.9 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 1 | 37.5 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 2 | 28.6 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 2 | 25.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 1 | 14.3 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 3 | 37.5 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 2 | 27.8 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 1 | 33.3 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 2 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 1 | 24.1 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 1 | 31.6 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 0 | 33.3 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 4 | 6.9 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 4 | 5.3 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 3 | 11.1 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 0 | 15.8 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 2 | 37.9 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 3 | 21.1 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 1 | 55.6 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 3 | 31.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 2 | 26.3 percentage of participants |
Secondary
Percentage of Participants in Each Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) Category at Week 24
The severity of vitiligo was assessed by the physician using the PhGVA, which has a 5-point scale. 0=clear, no signs of vitiligo; 1=almost clear, only specks of depigmentation present; 2=mild disease, pigmented and depigmented areas are equal; 3=moderate disease, more or complete depigmentation (may include \< 30% hair whitening); 4=severe disease, complete depigmentation plus \> 30% hair whitening.
Time frame: Week 24
Population: ITT Population. Missing post-Baseline values were considered as not having achieved F-PhGVA response for visits up to Week 24.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) Category at Week 24 | 0 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) Category at Week 24 | 1 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) Category at Week 24 | 2 | 6.3 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) Category at Week 24 | 3 | 40.6 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) Category at Week 24 | 4 | 34.4 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) Category at Week 24 | Missing at the visit | 18.8 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) Category at Week 24 | 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) Category at Week 24 | Missing at the visit | 16.1 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) Category at Week 24 | 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) Category at Week 24 | 2 | 16.1 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) Category at Week 24 | 3 | 64.5 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) Category at Week 24 | 1 | 3.2 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) Category at Week 24 | 3 | 61.3 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) Category at Week 24 | 4 | 9.7 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) Category at Week 24 | 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) Category at Week 24 | 2 | 16.1 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) Category at Week 24 | 1 | 9.7 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) Category at Week 24 | Missing at the visit | 3.2 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) Category at Week 24 | 3 | 36.7 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) Category at Week 24 | 1 | 13.3 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) Category at Week 24 | 2 | 20.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) Category at Week 24 | Missing at the visit | 13.3 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) Category at Week 24 | 4 | 16.7 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) Category at Week 24 | 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) Category at Week 24 | 4 | 3.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) Category at Week 24 | 2 | 27.3 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) Category at Week 24 | 1 | 9.1 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) Category at Week 24 | Missing at the visit | 6.1 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) Category at Week 24 | 3 | 54.5 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) Category at Week 24 | 0 | 0.0 percentage of participants |
p-value: 0.4936exact logistic regression
p-value: 0.114exact logistic regression
p-value: 0.0501exact logistic regression
p-value: 0.1257exact logistic regression
Secondary
Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156
The PaGIC-V is an assessment of improvement by the participant. It is a 7-point scale comparing the vitiligo areas at Baseline with the participant's treated areas of vitiligo at the study visit. The participant answered the following: Since the start of the treatment you've received in this study, your vitiligo in areas treated with the study drug is: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; and 7, very much worse.
Time frame: Baseline; Weeks 52, 104, and 156
Population: ITT Population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Twice Daily (BID) | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 6 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 7 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 1 | 50.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 3 | 30.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 7 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 4 | 20.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 6 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 5 | 20.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 6 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 1 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 5 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 7 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 1 | 11.1 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 4 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 2 | 33.3 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 2 | 30.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 3 | 22.2 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 3 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 4 | 22.2 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 5 | 11.1 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 2 | 50.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 1 | 7.1 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 7 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 4 | 7.1 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 7 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 1 | 25.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 6 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 6 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 6 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 1 | 25.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 3 | 42.9 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 3 | 62.5 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 5 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 2 | 25.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 5 | 28.6 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 2 | 12.5 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 7 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 2 | 14.3 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 5 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 3 | 50.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 2 | 25.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 6 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 6 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 1 | 20.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 7 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 3 | 33.3 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 4 | 11.1 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 3 | 58.3 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 6 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 5 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 7 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 5 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 1 | 8.3 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 4 | 20.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 2 | 20.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 1 | 11.1 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 4 | 8.3 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 7 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 3 | 40.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 2 | 44.4 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 5 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 2 | 33.3 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 4 | 15.4 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 2 | 60.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 2 | 23.1 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 5 | 7.7 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 1 | 7.7 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 5 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 6 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 4 | 22.2 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 7 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 7 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 4 | 20.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 1 | 22.2 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 5 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 3 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 6 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 1 | 20.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 7 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 3 | 22.2 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 3 | 46.2 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 6 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 3 | 55.2 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 1 | 10.3 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 2 | 20.7 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 4 | 6.9 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 5 | 3.4 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 6 | 3.4 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 7 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 1 | 10.5 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 2 | 36.8 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 3 | 47.4 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 4 | 5.3 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 5 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 6 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 7 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 1 | 12.5 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 2 | 25.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 3 | 62.5 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 5 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 6 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 7 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 2 | 50.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 6 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 3 | 12.5 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 5 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 5 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 3 | 22.2 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 5 | 12.5 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 1 | 22.2 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 4 | 11.1 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 4 | 9.5 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 7 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 3 | 38.1 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 2 | 47.6 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 7 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 1 | 4.8 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 7 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 6 | 5.6 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 6 | 12.5 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 1 | 12.5 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 2 | 38.9 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 1 | 11.1 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 3 | 36.8 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 2 | 31.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 2 | 77.8 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 2 | 36.8 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 1 | 13.8 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 3 | 11.1 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 1 | 21.1 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 7 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 6 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 6 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 5 | 6.9 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 7 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 156, 5 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 4 | 20.7 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 52, 3 | 27.6 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 7 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 6 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156 | Week 104, 5 | 5.3 percentage of participants |
Secondary
Percentage of Participants in Each Patient Global Impression of Change for Vitiligo (PaGIC-V) Category at Week 24
The PaGIC-V is an assessment of improvement by the participant. It is a 7-point scale comparing the vitiligo areas at Baseline with the participant's treated areas of vitiligo at the study visit. The participant answered the following: Since the start of the treatment you've received in this study, your vitiligo in areas treated with the study drug is: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; and 7, very much worse.
Time frame: Baseline; Week 24
Population: ITT Population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Patient Global Impression of Change for Vitiligo (PaGIC-V) Category at Week 24 | 1 | 7.4 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Patient Global Impression of Change for Vitiligo (PaGIC-V) Category at Week 24 | 7 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Patient Global Impression of Change for Vitiligo (PaGIC-V) Category at Week 24 | 6 | 11.1 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Patient Global Impression of Change for Vitiligo (PaGIC-V) Category at Week 24 | 3 | 22.2 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Patient Global Impression of Change for Vitiligo (PaGIC-V) Category at Week 24 | 2 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Patient Global Impression of Change for Vitiligo (PaGIC-V) Category at Week 24 | 4 | 37.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Patient Global Impression of Change for Vitiligo (PaGIC-V) Category at Week 24 | 5 | 22.2 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Patient Global Impression of Change for Vitiligo (PaGIC-V) Category at Week 24 | 5 | 11.5 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Patient Global Impression of Change for Vitiligo (PaGIC-V) Category at Week 24 | 4 | 26.9 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Patient Global Impression of Change for Vitiligo (PaGIC-V) Category at Week 24 | 2 | 19.2 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Patient Global Impression of Change for Vitiligo (PaGIC-V) Category at Week 24 | 1 | 3.8 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Patient Global Impression of Change for Vitiligo (PaGIC-V) Category at Week 24 | 6 | 3.8 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Patient Global Impression of Change for Vitiligo (PaGIC-V) Category at Week 24 | 3 | 34.6 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Patient Global Impression of Change for Vitiligo (PaGIC-V) Category at Week 24 | 7 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Patient Global Impression of Change for Vitiligo (PaGIC-V) Category at Week 24 | 4 | 23.3 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Patient Global Impression of Change for Vitiligo (PaGIC-V) Category at Week 24 | 1 | 6.7 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Patient Global Impression of Change for Vitiligo (PaGIC-V) Category at Week 24 | 2 | 13.3 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Patient Global Impression of Change for Vitiligo (PaGIC-V) Category at Week 24 | 3 | 50.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Patient Global Impression of Change for Vitiligo (PaGIC-V) Category at Week 24 | 5 | 6.7 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Patient Global Impression of Change for Vitiligo (PaGIC-V) Category at Week 24 | 6 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Patient Global Impression of Change for Vitiligo (PaGIC-V) Category at Week 24 | 7 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Patient Global Impression of Change for Vitiligo (PaGIC-V) Category at Week 24 | 3 | 53.8 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Patient Global Impression of Change for Vitiligo (PaGIC-V) Category at Week 24 | 5 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Patient Global Impression of Change for Vitiligo (PaGIC-V) Category at Week 24 | 2 | 19.2 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Patient Global Impression of Change for Vitiligo (PaGIC-V) Category at Week 24 | 7 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Patient Global Impression of Change for Vitiligo (PaGIC-V) Category at Week 24 | 6 | 3.8 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Patient Global Impression of Change for Vitiligo (PaGIC-V) Category at Week 24 | 1 | 11.5 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Patient Global Impression of Change for Vitiligo (PaGIC-V) Category at Week 24 | 4 | 11.5 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Patient Global Impression of Change for Vitiligo (PaGIC-V) Category at Week 24 | 3 | 35.5 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Patient Global Impression of Change for Vitiligo (PaGIC-V) Category at Week 24 | 7 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Patient Global Impression of Change for Vitiligo (PaGIC-V) Category at Week 24 | 6 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Patient Global Impression of Change for Vitiligo (PaGIC-V) Category at Week 24 | 5 | 9.7 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Patient Global Impression of Change for Vitiligo (PaGIC-V) Category at Week 24 | 2 | 22.6 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Patient Global Impression of Change for Vitiligo (PaGIC-V) Category at Week 24 | 1 | 6.5 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Patient Global Impression of Change for Vitiligo (PaGIC-V) Category at Week 24 | 4 | 25.8 percentage of participants |
Secondary
Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Week 24
The severity of vitiligo was assessed by the participant using the PaGVA, which has a 5-point scale. The participant was asked the following: How severe is your vitiligo on your face (or total body) with respect to the area covered by white skin? Responses: 0=no white patches (no vitiligo); 1=mild; 2=moderate; 3=severe; 4=very severe.
Time frame: Week 24
Population: ITT Population. Missing post-Baseline values were considered as not having achieved T-PaGVA response for visits up to Week 24.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Week 24 | 0 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Week 24 | 1 | 6.3 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Week 24 | 2 | 37.5 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Week 24 | 3 | 31.3 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Week 24 | 4 | 9.4 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Week 24 | Missing at the visit | 15.6 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Week 24 | 4 | 6.5 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Week 24 | Missing at the visit | 16.1 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Week 24 | 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Week 24 | 2 | 35.5 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Week 24 | 3 | 29.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Week 24 | 1 | 12.9 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Week 24 | 3 | 35.5 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Week 24 | 4 | 9.7 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Week 24 | 0 | 3.2 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Week 24 | 2 | 38.7 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Week 24 | 1 | 9.7 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Week 24 | Missing at the visit | 3.2 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Week 24 | 3 | 30.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Week 24 | 1 | 16.7 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Week 24 | 2 | 33.3 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Week 24 | Missing at the visit | 13.3 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Week 24 | 4 | 6.7 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Week 24 | 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Week 24 | 4 | 12.1 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Week 24 | 2 | 45.5 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Week 24 | 1 | 15.2 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Week 24 | Missing at the visit | 6.1 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Week 24 | 3 | 21.2 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Week 24 | 0 | 0.0 percentage of participants |
Secondary
Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156
The severity of vitiligo was assessed by the participant using the PaGVA, which has a 5-point scale. The participant was asked the following: How severe is your vitiligo on your face (or total body) with respect to the area covered by white skin? Responses: 0=no white patches (no vitiligo); 1=mild; 2=moderate; 3=severe; 4=very severe.
Time frame: Weeks 52, 104, and 156
Population: ITT Population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 2 | 55.6 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 4 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 1 | 20.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 1 | 50.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 4 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 2 | 50.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 3 | 20.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 0 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 1 | 33.3 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 4 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 0 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 0 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 3 | 11.1 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 3 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 2 | 60.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 2 | 50.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 3 | 25.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 1 | 7.1 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 3 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 2 | 50.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 2 | 75.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 3 | 42.9 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 1 | 25.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 1 | 25.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 1 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 2 | 44.4 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 3 | 40.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 3 | 55.6 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 3 | 50.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 1 | 20.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 1 | 8.3 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 2 | 40.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 2 | 41.7 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 2 | 77.8 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 1 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 2 | 69.2 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 3 | 23.1 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 4 | 7.7 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 1 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 3 | 22.2 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 1 | 20.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 2 | 40.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 3 | 40.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 2 | 42.1 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 1 | 13.8 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 2 | 50.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 4 | 5.3 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 3 | 27.6 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 1 | 37.5 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 1 | 36.8 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 2 | 48.3 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 3 | 12.5 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 3 | 15.8 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 4 | 10.3 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 4 | 25.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 3 | 16.7 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 4 | 16.7 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 4 | 10.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 3 | 25.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 1 | 12.5 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 2 | 40.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 2 | 37.5 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 1 | 25.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 3 | 25.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 2 | 44.4 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 1 | 22.2 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 2 | 55.6 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 1 | 13.8 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 1 | 15.8 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 4 | 13.8 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 4 | 5.3 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 3 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 2 | 62.1 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 3 | 21.1 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 1 | 33.3 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 156, 4 | 11.1 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 52, 3 | 10.3 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156 | Week 104, 2 | 57.9 percentage of participants |
Secondary
Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Week 24
The severity of vitiligo was assessed by the physician using the PhGVA, which has a 5-point scale. 0=clear, no signs of vitiligo; 1=almost clear, only specks of depigmentation present; 2=mild disease, pigmented and depigmented areas are equal; 3=moderate disease, more or complete depigmentation (may include \< 30% hair whitening); 4=severe disease, complete depigmentation plus \> 30% hair whitening.
Time frame: Week 24
Population: ITT Population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Week 24 | 3 | 57.7 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Week 24 | 0 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Week 24 | 4 | 30.8 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Week 24 | 1 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Week 24 | 2 | 11.5 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Week 24 | 3 | 76.9 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Week 24 | 2 | 23.1 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Week 24 | 1 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Week 24 | 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Week 24 | 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Week 24 | 2 | 20.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Week 24 | 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Week 24 | 1 | 3.3 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Week 24 | 3 | 70.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Week 24 | 4 | 6.7 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Week 24 | 4 | 15.4 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Week 24 | 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Week 24 | 3 | 61.5 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Week 24 | 2 | 23.1 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Week 24 | 1 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Week 24 | 2 | 35.5 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Week 24 | 3 | 58.1 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Week 24 | 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Week 24 | 4 | 3.2 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Week 24 | 1 | 3.2 percentage of participants |
Secondary
Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156
The severity of vitiligo was assessed by the physician using the PhGVA, which has a 5-point scale. 0=clear, no signs of vitiligo; 1=almost clear, only specks of depigmentation present; 2=mild disease, pigmented and depigmented areas are equal; 3=moderate disease, more or complete depigmentation (may include \< 30% hair whitening); 4=severe disease, complete depigmentation plus \> 30% hair whitening.
Time frame: Weeks 52, 104, and 156
Population: ITT Population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 2 | 77.8 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 4 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 1 | 10.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 1 | 50.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 4 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 2 | 50.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 3 | 40.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 0 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 1 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 4 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 0 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 0 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 3 | 22.2 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 3 | 0.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 2 | 50.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 2 | 37.5 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 3 | 37.5 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 1 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 3 | 50.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 2 | 35.7 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 2 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 3 | 57.1 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 1 | 50.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 4 | 7.1 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 1 | 25.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 4 | 8.3 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 1 | 11.1 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 2 | 33.3 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 3 | 60.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 3 | 44.4 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 3 | 83.3 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 4 | 20.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 1 | 20.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 1 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 2 | 0.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 2 | 8.3 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 4 | 11.1 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 2 | 33.3 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 1 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 2 | 7.7 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 3 | 84.6 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 4 | 7.7 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 1 | 11.1 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 3 | 55.6 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 1 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 2 | 60.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 3 | 40.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 2 | 68.4 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 1 | 10.3 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 2 | 50.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 3 | 69.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 1 | 25.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 1 | 5.3 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 2 | 13.8 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 3 | 25.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 3 | 26.3 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 4 | 6.9 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 4 | 12.5 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 3 | 27.8 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 4 | 16.7 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 4 | 9.5 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 3 | 61.9 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 1 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 2 | 28.6 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 2 | 62.5 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 1 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 3 | 25.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 2 | 55.6 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 1 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 2 | 66.7 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 1 | 6.9 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 1 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 4 | 6.9 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 3 | 22.2 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 0 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 2 | 55.2 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 3 | 36.8 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 1 | 11.1 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 156, 4 | 0.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 52, 3 | 31.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156 | Week 104, 2 | 63.2 percentage of participants |
Secondary
Percentage of Participants Who Achieved a ≥ 50% Improvement From Baseline in Full Body Assessment of Vitiligo Area and Severity Index (T-VASI) at Week 52
T-VASI was measured by the percentage of vitiligo involvement from all body regions (percentage of BSA; assessed by the Investigator) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was derived by multiplying the vitiligo involvement values by the percentage of affected skin for each body site and summing all values (possible range: 0-100; lower scores indicate increased improvement).
Time frame: Baseline; Week 52
Population: ITT Population. Missing post-Baseline values were considered as not having achieved responses for visits up to Week 52. Only participants with available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vehicle Twice Daily (BID) | Percentage of Participants Who Achieved a ≥ 50% Improvement From Baseline in Full Body Assessment of Vitiligo Area and Severity Index (T-VASI) at Week 52 | 50 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants Who Achieved a ≥ 50% Improvement From Baseline in Full Body Assessment of Vitiligo Area and Severity Index (T-VASI) at Week 52 | 21.4 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants Who Achieved a ≥ 50% Improvement From Baseline in Full Body Assessment of Vitiligo Area and Severity Index (T-VASI) at Week 52 | 16.7 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants Who Achieved a ≥ 50% Improvement From Baseline in Full Body Assessment of Vitiligo Area and Severity Index (T-VASI) at Week 52 | 15.4 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants Who Achieved a ≥ 50% Improvement From Baseline in Full Body Assessment of Vitiligo Area and Severity Index (T-VASI) at Week 52 | 25.8 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants Who Achieved a ≥ 50% Improvement From Baseline in Full Body Assessment of Vitiligo Area and Severity Index (T-VASI) at Week 52 | 30.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants Who Achieved a ≥ 50% Improvement From Baseline in Full Body Assessment of Vitiligo Area and Severity Index (T-VASI) at Week 52 | 36.4 percentage of participants |
p-value: 0.979495% CI: [0.33, 4.33]exact logistic regression
p-value: 0.489395% CI: [0.51, 5.86]exact logistic regression
Secondary
Percentage of Participants Who Achieved a Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) of Clear or Almost Clear
The severity of vitiligo was assessed by the physician using the PhGVA, which has a 5-point scale. 0=clear, no signs of vitiligo; 1=almost clear, only specks of depigmentation present; 2=mild disease, pigmented and depigmented areas are equal; 3=moderate disease, more or complete depigmentation (may include \< 30% hair whitening); 4=severe disease, complete depigmentation plus \> 30% hair whitening.
Time frame: Week 24
Population: ITT Population. Missing post-Baseline values were considered as not having achieved F-PhGVA response for visits up to Week 24.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vehicle Twice Daily (BID) | Percentage of Participants Who Achieved a Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) of Clear or Almost Clear | 0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants Who Achieved a Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) of Clear or Almost Clear | 3.2 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants Who Achieved a Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) of Clear or Almost Clear | 9.7 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants Who Achieved a Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) of Clear or Almost Clear | 13.3 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants Who Achieved a Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) of Clear or Almost Clear | 9.1 percentage of participants |
p-value: 0.4936exact logistic regression
p-value: 0.114exact logistic regression
p-value: 0.0501exact logistic regression
p-value: 0.1257exact logistic regression
Secondary
Percentage of Participants Who Achieved an F-VASI50 at Weeks 52, 104, and 156
An F-VASI50 responder achieved at least 50% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement).
Time frame: Baseline; Weeks 52, 104, and 156
Population: ITT Population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Twice Daily (BID) | Percentage of Participants Who Achieved an F-VASI50 at Weeks 52, 104, and 156 | Week 156 | 100.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants Who Achieved an F-VASI50 at Weeks 52, 104, and 156 | Week 104 | 88.9 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants Who Achieved an F-VASI50 at Weeks 52, 104, and 156 | Week 52 | 90.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants Who Achieved an F-VASI50 at Weeks 52, 104, and 156 | Week 104 | 87.5 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants Who Achieved an F-VASI50 at Weeks 52, 104, and 156 | Week 52 | 64.3 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants Who Achieved an F-VASI50 at Weeks 52, 104, and 156 | Week 156 | 75.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants Who Achieved an F-VASI50 at Weeks 52, 104, and 156 | Week 156 | 100.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants Who Achieved an F-VASI50 at Weeks 52, 104, and 156 | Week 52 | 50.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants Who Achieved an F-VASI50 at Weeks 52, 104, and 156 | Week 104 | 88.9 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants Who Achieved an F-VASI50 at Weeks 52, 104, and 156 | Week 104 | 77.8 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants Who Achieved an F-VASI50 at Weeks 52, 104, and 156 | Week 52 | 38.5 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants Who Achieved an F-VASI50 at Weeks 52, 104, and 156 | Week 156 | 60.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants Who Achieved an F-VASI50 at Weeks 52, 104, and 156 | Week 104 | 78.9 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants Who Achieved an F-VASI50 at Weeks 52, 104, and 156 | Week 52 | 45.2 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants Who Achieved an F-VASI50 at Weeks 52, 104, and 156 | Week 156 | 87.5 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants Who Achieved an F-VASI50 at Weeks 52, 104, and 156 | Week 52 | 43.3 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants Who Achieved an F-VASI50 at Weeks 52, 104, and 156 | Week 156 | 87.5 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants Who Achieved an F-VASI50 at Weeks 52, 104, and 156 | Week 104 | 83.3 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants Who Achieved an F-VASI50 at Weeks 52, 104, and 156 | Week 156 | 100.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants Who Achieved an F-VASI50 at Weeks 52, 104, and 156 | Week 104 | 89.5 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants Who Achieved an F-VASI50 at Weeks 52, 104, and 156 | Week 52 | 57.6 percentage of participants |
Secondary
Percentage of Participants Who Report a PaGIC-V Score of Very Much Improved or Much Improved at Week 24
The PaGIC-V is an assessment of improvement by the participant. It is a 7-point scale comparing the vitiligo areas at Baseline with the participant's treated areas of vitiligo at the study visit. The participant answered the following: Since the start of the treatment you've received in this study, your vitiligo in areas treated with the study drug is: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; and 7, very much worse.
Time frame: Baseline; Week 24
Population: ITT Population. Only participants with available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vehicle Twice Daily (BID) | Percentage of Participants Who Report a PaGIC-V Score of Very Much Improved or Much Improved at Week 24 | 7.4 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants Who Report a PaGIC-V Score of Very Much Improved or Much Improved at Week 24 | 23.1 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants Who Report a PaGIC-V Score of Very Much Improved or Much Improved at Week 24 | 20.0 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants Who Report a PaGIC-V Score of Very Much Improved or Much Improved at Week 24 | 30.8 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants Who Report a PaGIC-V Score of Very Much Improved or Much Improved at Week 24 | 29.0 percentage of participants |
Secondary
Percentage of Participants Who Report a PaGIC-V Score of Very Much Improved or Much Improved at Weeks 52, 104, and 156
The PaGIC-V is an assessment of improvement by the participant. It is a 7-point scale comparing the vitiligo areas at Baseline with the participant's treated areas of vitiligo at the study visit. The participant answered the following: Since the start of the treatment you've received in this study, your vitiligo in areas treated with the study drug is: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; and 7, very much worse.
Time frame: Baseline; Weeks 52, 104, and 156
Population: ITT Population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Twice Daily (BID) | Percentage of Participants Who Report a PaGIC-V Score of Very Much Improved or Much Improved at Weeks 52, 104, and 156 | Week 156 | 100.0 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants Who Report a PaGIC-V Score of Very Much Improved or Much Improved at Weeks 52, 104, and 156 | Week 104 | 44.4 percentage of participants |
| Vehicle Twice Daily (BID) | Percentage of Participants Who Report a PaGIC-V Score of Very Much Improved or Much Improved at Weeks 52, 104, and 156 | Week 52 | 30.0 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants Who Report a PaGIC-V Score of Very Much Improved or Much Improved at Weeks 52, 104, and 156 | Week 104 | 37.5 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants Who Report a PaGIC-V Score of Very Much Improved or Much Improved at Weeks 52, 104, and 156 | Week 52 | 21.4 percentage of participants |
| Ruxolitinib Cream 0.15% QD | Percentage of Participants Who Report a PaGIC-V Score of Very Much Improved or Much Improved at Weeks 52, 104, and 156 | Week 156 | 50.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants Who Report a PaGIC-V Score of Very Much Improved or Much Improved at Weeks 52, 104, and 156 | Week 156 | 40.0 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants Who Report a PaGIC-V Score of Very Much Improved or Much Improved at Weeks 52, 104, and 156 | Week 52 | 33.3 percentage of participants |
| Ruxolitinib Cream 0.5% QD | Percentage of Participants Who Report a PaGIC-V Score of Very Much Improved or Much Improved at Weeks 52, 104, and 156 | Week 104 | 55.6 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants Who Report a PaGIC-V Score of Very Much Improved or Much Improved at Weeks 52, 104, and 156 | Week 104 | 55.6 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants Who Report a PaGIC-V Score of Very Much Improved or Much Improved at Weeks 52, 104, and 156 | Week 52 | 30.8 percentage of participants |
| Ruxolitinib Cream 1.5% QD | Percentage of Participants Who Report a PaGIC-V Score of Very Much Improved or Much Improved at Weeks 52, 104, and 156 | Week 156 | 80.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants Who Report a PaGIC-V Score of Very Much Improved or Much Improved at Weeks 52, 104, and 156 | Week 104 | 47.4 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants Who Report a PaGIC-V Score of Very Much Improved or Much Improved at Weeks 52, 104, and 156 | Week 52 | 31.0 percentage of participants |
| Ruxolitinib Cream 1.5% BID | Percentage of Participants Who Report a PaGIC-V Score of Very Much Improved or Much Improved at Weeks 52, 104, and 156 | Week 156 | 37.5 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants Who Report a PaGIC-V Score of Very Much Improved or Much Improved at Weeks 52, 104, and 156 | Week 52 | 52.4 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants Who Report a PaGIC-V Score of Very Much Improved or Much Improved at Weeks 52, 104, and 156 | Week 156 | 62.5 percentage of participants |
| Ruxolitinib Cream 1.5% QD: 1.5 % BID | Percentage of Participants Who Report a PaGIC-V Score of Very Much Improved or Much Improved at Weeks 52, 104, and 156 | Week 104 | 61.1 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants Who Report a PaGIC-V Score of Very Much Improved or Much Improved at Weeks 52, 104, and 156 | Week 156 | 88.9 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants Who Report a PaGIC-V Score of Very Much Improved or Much Improved at Weeks 52, 104, and 156 | Week 104 | 57.9 percentage of participants |
| Ruxolitinib Cream 1.5% BID: 1.5% BID | Percentage of Participants Who Report a PaGIC-V Score of Very Much Improved or Much Improved at Weeks 52, 104, and 156 | Week 52 | 44.8 percentage of participants |
Secondary
Time to Achieve an F-PhGVA of Clear or Almost Clear
The severity of vitiligo was assessed by the physician using the PhGVA, which has a 5-point scale. 0=clear, no signs of vitiligo; 1=almost clear, only specks of depigmentation present; 2=mild disease, pigmented and depigmented areas are equal; 3=moderate disease, more or complete depigmentation (may include \< 30% hair whitening); 4=severe disease, complete depigmentation plus \> 30% hair whitening. Time to achieve an F-PhGVA response was defined as the number of days from the date of the first application in the Double-Blind Period to the date of the first evaluation at which the participant met the F-PhGVA score.
Time frame: up to 52 weeks
Population: ITT Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vehicle Twice Daily (BID) | Time to Achieve an F-PhGVA of Clear or Almost Clear | NA days |
| Ruxolitinib Cream 0.15% QD | Time to Achieve an F-PhGVA of Clear or Almost Clear | 372.0 days |
| Ruxolitinib Cream 0.5% QD | Time to Achieve an F-PhGVA of Clear or Almost Clear | NA days |
| Ruxolitinib Cream 1.5% QD | Time to Achieve an F-PhGVA of Clear or Almost Clear | NA days |
| Ruxolitinib Cream 1.5% BID | Time to Achieve an F-PhGVA of Clear or Almost Clear | NA days |
Secondary
Time to Achieve an F-VASI50: Number of Days From the Date of the First Application in the Double-Blind Period to the Date of the First Evaluation at Which the Participant Met the F-VASI50 Score
An F-VASI50 responder achieved at least 50% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the nearest 0.1% by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement).
Time frame: up to 52 weeks
Population: ITT Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vehicle Twice Daily (BID) | Time to Achieve an F-VASI50: Number of Days From the Date of the First Application in the Double-Blind Period to the Date of the First Evaluation at Which the Participant Met the F-VASI50 Score | NA days |
| Ruxolitinib Cream 0.15% QD | Time to Achieve an F-VASI50: Number of Days From the Date of the First Application in the Double-Blind Period to the Date of the First Evaluation at Which the Participant Met the F-VASI50 Score | 197.0 days |
| Ruxolitinib Cream 0.5% QD | Time to Achieve an F-VASI50: Number of Days From the Date of the First Application in the Double-Blind Period to the Date of the First Evaluation at Which the Participant Met the F-VASI50 Score | 339.0 days |
| Ruxolitinib Cream 1.5% QD | Time to Achieve an F-VASI50: Number of Days From the Date of the First Application in the Double-Blind Period to the Date of the First Evaluation at Which the Participant Met the F-VASI50 Score | 172.0 days |
| Ruxolitinib Cream 1.5% BID | Time to Achieve an F-VASI50: Number of Days From the Date of the First Application in the Double-Blind Period to the Date of the First Evaluation at Which the Participant Met the F-VASI50 Score | 170.0 days |
Secondary
Time to Achieve an T-PhGVA of Clear or Almost Clear
The severity of vitiligo was assessed by the physician using the PhGVA, which has a 5-point scale. 0=clear, no signs of vitiligo; 1=almost clear, only specks of depigmentation present; 2=mild disease, pigmented and depigmented areas are equal; 3=moderate disease, more or complete depigmentation (may include \< 30% hair whitening); 4=severe disease, complete depigmentation plus \> 30% hair whitening. Time to achieve a T-PhGVA response was defined as the number of days from the date of the first application in the Double-Blind Period to the date of the first evaluation at which the participant met the T-PhGVA score.
Time frame: up to 52 weeks
Population: ITT Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vehicle Twice Daily (BID) | Time to Achieve an T-PhGVA of Clear or Almost Clear | NA days |
| Ruxolitinib Cream 0.15% QD | Time to Achieve an T-PhGVA of Clear or Almost Clear | 372.0 days |
| Ruxolitinib Cream 0.5% QD | Time to Achieve an T-PhGVA of Clear or Almost Clear | NA days |
| Ruxolitinib Cream 1.5% QD | Time to Achieve an T-PhGVA of Clear or Almost Clear | NA days |
| Ruxolitinib Cream 1.5% BID | Time to Achieve an T-PhGVA of Clear or Almost Clear | NA days |
Secondary
Time to Achieve a PaGIC-V of Very Much Improved or Much Improved
The PaGIC-V is an assessment of improvement by the participant. It is a 7-point scale comparing the vitiligo areas at Baseline with the participant's treated areas of vitiligo at the study visit. The participant answered the following: Since the start of the treatment you've received in this study, your vitiligo in areas treated with the study drug is: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; and 7, very much worse. Time to achieve a PaGIC-V response was defined as the number of days from the date of the first application in the Double-Blind Period to the date of the first evaluation at which the participant met the PaGIC-V score.
Time frame: up to 52 weeks
Population: ITT Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vehicle Twice Daily (BID) | Time to Achieve a PaGIC-V of Very Much Improved or Much Improved | NA days |
| Ruxolitinib Cream 0.15% QD | Time to Achieve a PaGIC-V of Very Much Improved or Much Improved | NA days |
| Ruxolitinib Cream 0.5% QD | Time to Achieve a PaGIC-V of Very Much Improved or Much Improved | NA days |
| Ruxolitinib Cream 1.5% QD | Time to Achieve a PaGIC-V of Very Much Improved or Much Improved | 282.0 days |
| Ruxolitinib Cream 1.5% BID | Time to Achieve a PaGIC-V of Very Much Improved or Much Improved | 281.0 days |
Secondary
Time to Achieve a T-VASI50: Number of Days From the Date of the First Application in the Double-Blind Period to the Date of the First Evaluation at Which the Participant Met the T-VASI50 Score
A T-VASI50 responder achieved at least 50% improvement from Baseline in T-VASI. T-VASI was measured by the percentage of vitiligo involvement from all body regions (percentage of BSA; assessed by the Investigator) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was derived by multiplying the vitiligo involvement values by the percentage of affected skin for each body site and summing all values (possible range: 0-100; lower scores indicate increased improvement).
Time frame: up to 52 weeks
Population: ITT Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vehicle Twice Daily (BID) | Time to Achieve a T-VASI50: Number of Days From the Date of the First Application in the Double-Blind Period to the Date of the First Evaluation at Which the Participant Met the T-VASI50 Score | NA days |
| Ruxolitinib Cream 0.15% QD | Time to Achieve a T-VASI50: Number of Days From the Date of the First Application in the Double-Blind Period to the Date of the First Evaluation at Which the Participant Met the T-VASI50 Score | NA days |
| Ruxolitinib Cream 0.5% QD | Time to Achieve a T-VASI50: Number of Days From the Date of the First Application in the Double-Blind Period to the Date of the First Evaluation at Which the Participant Met the T-VASI50 Score | NA days |
| Ruxolitinib Cream 1.5% QD | Time to Achieve a T-VASI50: Number of Days From the Date of the First Application in the Double-Blind Period to the Date of the First Evaluation at Which the Participant Met the T-VASI50 Score | NA days |
| Ruxolitinib Cream 1.5% BID | Time to Achieve a T-VASI50: Number of Days From the Date of the First Application in the Double-Blind Period to the Date of the First Evaluation at Which the Participant Met the T-VASI50 Score | 376.0 days |