Stasis Dermatitis
Conditions
Keywords
Stasis Dermatitis, venous hypertension, venous insufficiency
Brief summary
This is a Phase 2a, randomized, double blind, vehicle controlled, parallel group, proof of concept study that will include participants with stasis dermatitis without active skin ulceration, who will receive crisaborole ointment 2% or vehicle twice daily for 6 weeks.
Detailed description
Study C3291038 is a Phase 2a, randomized, double-blind, vehicle-controlled, parallel-group, proof of concept study to evaluate the efficacy, safety, and local tolerability of 6 weeks of treatment with crisaborole in adult participants with SD without active skin ulceration. Approximately 70 eligible participants will be randomized into the double blind treatment period in a 1:1 ratio to receive crisaborole ointment, 2% or vehicle twice daily for 6 weeks. The study will recruit male and female participants aged ≥ 45 years with a clinical diagnosis of SD. The total duration of participation in the study will be up to 14 weeks, including up to 4 weeks for screening, a 6 week double blind treatment period, and a follow-up period of 4 weeks after treatment completion. Study enrollment and management will be de centralized, where participants do not visit an investigator or a clinic for clinical assessment. The participants will participate in the study at home. The sponsor (or designee) will provide home visits by qualified home visit practitioners (HVP), remote contact by telemedicine (or telephone), and clinical database electronic case report forms (eCRFs), eDiary, and other electronic data entries from 3rd party vendors for study data collection.
Interventions
crisaborole ointment
OTHERvehicle ointment
vehicle ointment
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants who are ≥45 years of age and in generally stable health * Participants who are in generally stable health and have a known diagnosis of Stasis Dermatitis or newly diagnosed Stasis Dermatitis * Participants whose mental and physical status allows them to be able to mostly perform their activities of daily living with minimal assistance
Exclusion criteria
* Participants with clinically significant active or potentially recurrent dermatitis conditions and known genetic dermatological conditions that are not Stasis Dermatitis or overlap with Stasis Dermatitis * Participants with active venous stasis ulceration on either lower extremity. * Participants with current infection or suspected infection of any Stasis Dermatitis lesions * Women of child bearing potential (WOCBP) are not eligible for this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Total Sign Score (TSS) at Week 6: In-person Assessment | Baseline, Week 6 | TSS assesses severity of stasis dermatitis lesions. There were following 4 clinical signs of all treatable stasis dermatitis lesions: erythema, papulation/elevation, superficial erosion/denudation, and scaling. Each of 4 signs were rated on a scale of 0 to 3 (0= none, 1= mild, 2= moderate, 3= severe). TSS = sum of scores from all clinical signs; ranging from 0 (none) to 12 (most severe), where higher score indicated greater severity. The assessment was completed in person by the home visit practitioner. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 1, 2, 3, 4, 5 and 6 | ISGA: global assessment of stasis dermatitis lesions severity based on erythema, papulation/elevation, superficial erosion/denudation, and scaling, excluding scalp. ISGA score ranged from 0 to 4; 0 = clear (minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores = greater severity. Treatment success: ISGA score of clear/almost clear with at least a 2-grade improvement from baseline. Participants acquired static digital images of the lesions using sponsor-provisioned digital imaging equipment. Images were reviewed by central readers. |
| Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Week 6: In-person Assessment | Week 6 | ISGA is a global assessment of stasis dermatitis lesions severity based on erythema, papulation/elevation, superficial erosion/denudation, and scaling. ISGA excludes scalp from scoring and assessment. ISGA score ranged from 0 to 4; where 0 = clear (minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores indicated greater severity. The assessment was completed in person by the home visit practitioner. |
| Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 1, 2, 3, 4, 5 and 6 | ISGA is a global assessment of stasis dermatitis lesions severity based on erythema, papulation/elevation, superficial erosion/denudation, and scaling. ISGA excludes scalp from scoring and assessment. ISGA score ranged from 0 to 4; where 0 = clear (minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores indicated greater severity. Participants acquired static digital images of the lesions using sponsor-provisioned digital imaging equipment. Images were reviewed by central readers. |
| Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Week 6: In-person Assessment | Week 6 | ISGA is a global assessment of stasis dermatitis lesions severity based on erythema, papulation/elevation, superficial erosion/denudation, and scaling. ISGA excludes scalp from scoring and assessment. ISGA score ranged from 0 to 4; where 0 = clear (minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores indicated greater severity. The assessment was completed in person by the home visit practitioner. Treatment success was defined as ISGA score of clear/almost clear with at least a 2-grade improvement from baseline. |
| Percent Change From Baseline in Stasis Dermatitis Lesional Percent Body Surface Area (BSA) at Week 6: In-person Assessment | Baseline, Week 6 | Stasis dermatitis lesional BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area was counted. One handprint represented approximately 1% of lesional BSA. Percent BSA for a body region = total number of handprints in a body region \* % surface area equivalent to 1 handprint. Higher % BSA indicated greater severity. The assessment was completed in person by the home visit practitioner. |
| Percent Change From Baseline in Percent Body Surface Area (BSA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Baseline, Week 1, 2, 3, 4, 5 and 6 | Stasis dermatitis lesional BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area was counted. One handprint represented approximately 1% of lesional BSA. Percent BSA for a body region = total number of handprints in a body region \* % surface area equivalent to 1 handprint. Higher % BSA indicated greater severity. Participants acquired static digital images of the lesions using sponsor-provisioned digital imaging equipment. Images were reviewed by central readers. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks) | An adverse event (AE) was any untoward medical occurrence attributed to a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug and up to 4 weeks after last dose that were absent before treatment or that worsened relative to pre-treatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs included both SAEs and all non-SAEs. |
| Percent Change From Baseline in Total Sign Score (TSS) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Baseline, Week 1, 2, 3, 4, 5 and 6 | TSS assesses severity of stasis dermatitis lesions. There were following 4 clinical signs of all treatable stasis dermatitis lesions: erythema, papulation/elevation, superficial erosion/denudation, and scaling. Each of 4 signs were rated on a scale of 0 to 3 (0= none, 1= mild, 2= moderate, 3= severe). TSS = sum of scores from all clinical signs; ranging from 0 (none) to 12 (most severe), where higher score indicated greater severity. Participants acquired static digital images of the lesions using sponsor-provisioned digital imaging equipment. Images were reviewed by central readers. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vehicle Ointment Participants applied vehicle ointment topically BID to the stasis dermatitis affected lower extremities (knees to feet) for 6 weeks. Participants were followed-up for 4 weeks after treatment completion. | 32 |
| Crisaborole 2% Ointment Participants applied crisaborole ointment 2% topically BID to the stasis dermatitis affected lower extremities (knees to feet) for 6 weeks. Participants were followed-up for 4 weeks after treatment completion. | 33 |
| Total | 65 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 4 |
| Overall Study | Not treated | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 2 |
Baseline characteristics
| Characteristic | Crisaborole 2% Ointment | Total | Vehicle Ointment |
|---|---|---|---|
| Age, Continuous | 66.0 Years STANDARD_DEVIATION 8.64 | 67.4 Years STANDARD_DEVIATION 9.28 | 68.9 Years STANDARD_DEVIATION 9.81 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants | 61 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) White | 29 Participants | 60 Participants | 31 Participants |
| Sex: Female, Male Female | 16 Participants | 30 Participants | 14 Participants |
| Sex: Female, Male Male | 17 Participants | 35 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 33 |
| other Total, other adverse events | 13 / 32 | 13 / 33 |
| serious Total, serious adverse events | 4 / 32 | 1 / 33 |
Outcome results
Primary
Percent Change From Baseline in Total Sign Score (TSS) at Week 6: In-person Assessment
TSS assesses severity of stasis dermatitis lesions. There were following 4 clinical signs of all treatable stasis dermatitis lesions: erythema, papulation/elevation, superficial erosion/denudation, and scaling. Each of 4 signs were rated on a scale of 0 to 3 (0= none, 1= mild, 2= moderate, 3= severe). TSS = sum of scores from all clinical signs; ranging from 0 (none) to 12 (most severe), where higher score indicated greater severity. The assessment was completed in person by the home visit practitioner.
Time frame: Baseline, Week 6
Population: Full analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention. Participants were analyzed according to the intervention they were randomized. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Vehicle Ointment | Percent Change From Baseline in Total Sign Score (TSS) at Week 6: In-person Assessment | -18.07 Percent change | Standard Error 5.47 |
| Crisaborole 2% Ointment | Percent Change From Baseline in Total Sign Score (TSS) at Week 6: In-person Assessment | -32.44 Percent change | Standard Error 5.09 |
p-value: 0.029990% CI: [-26.87, -1.86]ANOVA
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An adverse event (AE) was any untoward medical occurrence attributed to a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug and up to 4 weeks after last dose that were absent before treatment or that worsened relative to pre-treatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs included both SAEs and all non-SAEs.
Time frame: Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Population: Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vehicle Ointment | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs | 14 Participants |
| Vehicle Ointment | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 4 Participants |
| Crisaborole 2% Ointment | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs | 13 Participants |
| Crisaborole 2% Ointment | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 1 Participants |
Secondary
Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment
ISGA: global assessment of stasis dermatitis lesions severity based on erythema, papulation/elevation, superficial erosion/denudation, and scaling, excluding scalp. ISGA score ranged from 0 to 4; 0 = clear (minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores = greater severity. Treatment success: ISGA score of clear/almost clear with at least a 2-grade improvement from baseline. Participants acquired static digital images of the lesions using sponsor-provisioned digital imaging equipment. Images were reviewed by central readers.
Time frame: Week 1, 2, 3, 4, 5 and 6
Population: Full analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention. Participants were analyzed according to the intervention they were randomized.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Ointment | Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 1 | 3.13 Percentage of participants |
| Vehicle Ointment | Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 2 | 15.63 Percentage of participants |
| Vehicle Ointment | Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 3 | 12.50 Percentage of participants |
| Vehicle Ointment | Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 4 | 12.50 Percentage of participants |
| Vehicle Ointment | Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 5 | 6.25 Percentage of participants |
| Vehicle Ointment | Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 6 | 0 Percentage of participants |
| Crisaborole 2% Ointment | Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 5 | 15.15 Percentage of participants |
| Crisaborole 2% Ointment | Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 1 | 12.12 Percentage of participants |
| Crisaborole 2% Ointment | Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 4 | 12.12 Percentage of participants |
| Crisaborole 2% Ointment | Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 2 | 15.15 Percentage of participants |
| Crisaborole 2% Ointment | Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 6 | 18.18 Percentage of participants |
| Crisaborole 2% Ointment | Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 3 | 12.12 Percentage of participants |
Comparison: Week 1p-value: 0.081990% CI: [-1.63, 19.62]Normal approximation test
Comparison: Week 2p-value: 0.478990% CI: [-15.2, 14.25]Normal approximation test
Comparison: Week 3p-value: 0.481590% CI: [-13.79, 13.03]Normal approximation test
Comparison: Week 4p-value: 0.481590% CI: [-13.79, 13.03]Normal approximation test
Comparison: Week 5p-value: 0.119790% CI: [-3.55, 21.35]Normal approximation test
Comparison: Week 6p-value: 0.003490% CI: [7.14, 29.23]Normal approximation test
Secondary
Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Week 6: In-person Assessment
ISGA is a global assessment of stasis dermatitis lesions severity based on erythema, papulation/elevation, superficial erosion/denudation, and scaling. ISGA excludes scalp from scoring and assessment. ISGA score ranged from 0 to 4; where 0 = clear (minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores indicated greater severity. The assessment was completed in person by the home visit practitioner. Treatment success was defined as ISGA score of clear/almost clear with at least a 2-grade improvement from baseline.
Time frame: Week 6
Population: Full analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention. Participants were analyzed according to the intervention they were randomized. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vehicle Ointment | Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Week 6: In-person Assessment | 0 Percentage of participants |
| Crisaborole 2% Ointment | Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Week 6: In-person Assessment | 3.33 Percentage of participants |
p-value: 0.154690% CI: [-2.06, 8.72]Normal approximation test
Secondary
Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment
ISGA is a global assessment of stasis dermatitis lesions severity based on erythema, papulation/elevation, superficial erosion/denudation, and scaling. ISGA excludes scalp from scoring and assessment. ISGA score ranged from 0 to 4; where 0 = clear (minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores indicated greater severity. Participants acquired static digital images of the lesions using sponsor-provisioned digital imaging equipment. Images were reviewed by central readers.
Time frame: Week 1, 2, 3, 4, 5 and 6
Population: Full analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention. Participants were analyzed according to the intervention they were randomized.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Ointment | Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 1 | 43.75 Percentage of participants |
| Vehicle Ointment | Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 2 | 37.50 Percentage of participants |
| Vehicle Ointment | Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 3 | 43.75 Percentage of participants |
| Vehicle Ointment | Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 4 | 43.75 Percentage of participants |
| Vehicle Ointment | Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 5 | 25.00 Percentage of participants |
| Vehicle Ointment | Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 6 | 21.88 Percentage of participants |
| Crisaborole 2% Ointment | Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 5 | 45.45 Percentage of participants |
| Crisaborole 2% Ointment | Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 1 | 51.52 Percentage of participants |
| Crisaborole 2% Ointment | Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 4 | 45.45 Percentage of participants |
| Crisaborole 2% Ointment | Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 2 | 54.55 Percentage of participants |
| Crisaborole 2% Ointment | Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 6 | 51.52 Percentage of participants |
| Crisaborole 2% Ointment | Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 3 | 45.45 Percentage of participants |
Comparison: Week 1p-value: 0.264890% CI: [-12.55, 28.08]Normal approximation test
Comparison: Week 2p-value: 0.080990% CI: [-2.99, 37.08]Normal approximation test
Comparison: Week 3p-value: 0.44590% CI: [-18.58, 21.99]Normal approximation test
Comparison: Week 4p-value: 0.44590% CI: [-18.58, 21.99]Normal approximation test
Comparison: Week 5p-value: 0.038590% CI: [1.43, 39.48]Normal approximation test
Comparison: Week 6p-value: 0.004590% CI: [10.95, 48.33]Normal approximation test
Secondary
Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Week 6: In-person Assessment
ISGA is a global assessment of stasis dermatitis lesions severity based on erythema, papulation/elevation, superficial erosion/denudation, and scaling. ISGA excludes scalp from scoring and assessment. ISGA score ranged from 0 to 4; where 0 = clear (minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores indicated greater severity. The assessment was completed in person by the home visit practitioner.
Time frame: Week 6
Population: Full analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention. Participants were analyzed according to the intervention they were randomized. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vehicle Ointment | Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Week 6: In-person Assessment | 11.54 Percentage of participants |
| Crisaborole 2% Ointment | Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Week 6: In-person Assessment | 16.67 Percentage of participants |
p-value: 0.289690% CI: [-10.09, 20.34]Normal approximation test
Secondary
Percent Change From Baseline in Percent Body Surface Area (BSA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment
Stasis dermatitis lesional BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area was counted. One handprint represented approximately 1% of lesional BSA. Percent BSA for a body region = total number of handprints in a body region \* % surface area equivalent to 1 handprint. Higher % BSA indicated greater severity. Participants acquired static digital images of the lesions using sponsor-provisioned digital imaging equipment. Images were reviewed by central readers.
Time frame: Baseline, Week 1, 2, 3, 4, 5 and 6
Population: Full analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention. Participants were analyzed according to the intervention they were randomized. Here, number analyzed signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle Ointment | Percent Change From Baseline in Percent Body Surface Area (BSA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 1 | 10.28 Percent change | Standard Error 14.73 |
| Vehicle Ointment | Percent Change From Baseline in Percent Body Surface Area (BSA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 2 | -13.21 Percent change | Standard Error 13.07 |
| Vehicle Ointment | Percent Change From Baseline in Percent Body Surface Area (BSA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 3 | -31.58 Percent change | Standard Error 10.85 |
| Vehicle Ointment | Percent Change From Baseline in Percent Body Surface Area (BSA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 4 | -2.34 Percent change | Standard Error 15.8 |
| Vehicle Ointment | Percent Change From Baseline in Percent Body Surface Area (BSA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 5 | -6.05 Percent change | Standard Error 13.87 |
| Vehicle Ointment | Percent Change From Baseline in Percent Body Surface Area (BSA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 6 | 18.67 Percent change | Standard Error 21.26 |
| Crisaborole 2% Ointment | Percent Change From Baseline in Percent Body Surface Area (BSA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 5 | -19.06 Percent change | Standard Error 13.91 |
| Crisaborole 2% Ointment | Percent Change From Baseline in Percent Body Surface Area (BSA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 1 | -19.67 Percent change | Standard Error 14.98 |
| Crisaborole 2% Ointment | Percent Change From Baseline in Percent Body Surface Area (BSA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 4 | -18.35 Percent change | Standard Error 15.93 |
| Crisaborole 2% Ointment | Percent Change From Baseline in Percent Body Surface Area (BSA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 2 | -27.59 Percent change | Standard Error 13.5 |
| Crisaborole 2% Ointment | Percent Change From Baseline in Percent Body Surface Area (BSA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 6 | -34.34 Percent change | Standard Error 21.23 |
| Crisaborole 2% Ointment | Percent Change From Baseline in Percent Body Surface Area (BSA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 3 | -41.52 Percent change | Standard Error 10.44 |
Comparison: Week 1p-value: 0.079790% CI: [-65.09, 5.18]Normal approximation test
Comparison: Week 2p-value: 0.223690% CI: [-45.81, 17.04]Normal approximation test
Comparison: Week 3p-value: 0.255990% CI: [-35.12, 15.24]Normal approximation test
Comparison: Week 4p-value: 0.239290% CI: [-53.54, 21.52]Normal approximation test
Comparison: Week 5p-value: 0.255390% CI: [-45.87, 19.85]Normal approximation test
Comparison: Week 6p-value: 0.041690% CI: [-103.26, -2.75]Normal approximation test
Secondary
Percent Change From Baseline in Stasis Dermatitis Lesional Percent Body Surface Area (BSA) at Week 6: In-person Assessment
Stasis dermatitis lesional BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area was counted. One handprint represented approximately 1% of lesional BSA. Percent BSA for a body region = total number of handprints in a body region \* % surface area equivalent to 1 handprint. Higher % BSA indicated greater severity. The assessment was completed in person by the home visit practitioner.
Time frame: Baseline, Week 6
Population: Full analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention. Participants were analyzed according to the intervention they were randomized. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Vehicle Ointment | Percent Change From Baseline in Stasis Dermatitis Lesional Percent Body Surface Area (BSA) at Week 6: In-person Assessment | -10.72 Percent change | Standard Error 7.06 |
| Crisaborole 2% Ointment | Percent Change From Baseline in Stasis Dermatitis Lesional Percent Body Surface Area (BSA) at Week 6: In-person Assessment | -3.80 Percent change | Standard Error 6.57 |
p-value: 0.238390% CI: [-9.23, 23.06]ANOVA
Secondary
Percent Change From Baseline in Total Sign Score (TSS) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment
TSS assesses severity of stasis dermatitis lesions. There were following 4 clinical signs of all treatable stasis dermatitis lesions: erythema, papulation/elevation, superficial erosion/denudation, and scaling. Each of 4 signs were rated on a scale of 0 to 3 (0= none, 1= mild, 2= moderate, 3= severe). TSS = sum of scores from all clinical signs; ranging from 0 (none) to 12 (most severe), where higher score indicated greater severity. Participants acquired static digital images of the lesions using sponsor-provisioned digital imaging equipment. Images were reviewed by central readers.
Time frame: Baseline, Week 1, 2, 3, 4, 5 and 6
Population: Full analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention. Participants were analyzed according to the intervention they were randomized. Here, number analyzed signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle Ointment | Percent Change From Baseline in Total Sign Score (TSS) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 1 | -20.35 Percent change | Standard Error 9.55 |
| Vehicle Ointment | Percent Change From Baseline in Total Sign Score (TSS) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 2 | -35.94 Percent change | Standard Error 8.14 |
| Vehicle Ointment | Percent Change From Baseline in Total Sign Score (TSS) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 3 | -34.86 Percent change | Standard Error 10.26 |
| Vehicle Ointment | Percent Change From Baseline in Total Sign Score (TSS) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 4 | -39.38 Percent change | Standard Error 11.14 |
| Vehicle Ointment | Percent Change From Baseline in Total Sign Score (TSS) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 5 | -27.23 Percent change | Standard Error 10.41 |
| Vehicle Ointment | Percent Change From Baseline in Total Sign Score (TSS) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 6 | -10.29 Percent change | Standard Error 8.6 |
| Crisaborole 2% Ointment | Percent Change From Baseline in Total Sign Score (TSS) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 5 | -28.89 Percent change | Standard Error 10.18 |
| Crisaborole 2% Ointment | Percent Change From Baseline in Total Sign Score (TSS) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 1 | -16.48 Percent change | Standard Error 9.52 |
| Crisaborole 2% Ointment | Percent Change From Baseline in Total Sign Score (TSS) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 4 | -4.64 Percent change | Standard Error 11.12 |
| Crisaborole 2% Ointment | Percent Change From Baseline in Total Sign Score (TSS) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 2 | -40.41 Percent change | Standard Error 8.26 |
| Crisaborole 2% Ointment | Percent Change From Baseline in Total Sign Score (TSS) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 6 | -52.48 Percent change | Standard Error 8.35 |
| Crisaborole 2% Ointment | Percent Change From Baseline in Total Sign Score (TSS) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Week 3 | -25.05 Percent change | Standard Error 9.85 |
Comparison: Week 1p-value: 0.387490% CI: [-18.67, 26.43]Normal approximation test
Comparison: Week 2p-value: 0.350690% CI: [-23.85, 14.91]Normal approximation test
Comparison: Week 3p-value: 0.246690% CI: [-13.97, 33.6]Normal approximation test
Comparison: Week 4p-value: 0.015790% CI: [8.43, 61.05]Normal approximation test
Comparison: Week 5p-value: 0.454890% CI: [-25.99, 22.68]Normal approximation test
Comparison: Week 6p-value: 0.000490% CI: [-62.24, -22.15]Normal approximation test