Atopic Dermatitis (AD)
Conditions
Keywords
atopic dermatitis (AD), adolescents, pruritus, eczema, topical therapy, JAK inhibitor
Brief summary
The purpose of this study is to evaluate the long-term safety and tolerability of ruxolitinib cream in adolescents with Atopic Dermatitis (AD).
Detailed description
The study comprises of a 8 week continuous treatment period followed by 44 week Long Term Safety (LTS) period and 30 days safety follow up period. During Continuous treatment period all lesions identified at baseline will be treated and during LTS period only active lesions will be treated.
Interventions
DRUGRuxolitinib Cream
Ruxolitinib cream 1.5% twice daily (BID) during the continuous and LTS treatment period.
Sponsors
Incyte Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* A diagnosis of Atopic Dermatitis (AD) as defined by the Hanifin and Rajka (1980) criteria. * Duration of AD of at least 2 years. * Total IGA score of 2 to 3 at the screening and baseline visits. * Percent BSA (excluding the scalp) with AD involvement of 3% to 20% at the screening and baseline visits. * Atopic dermatitis not adequately controlled with other topical prescription therapies or when those therapies are not advisable. * Agree to discontinue all agents used to treat AD from screening through the final follow up visit. * Willingness to avoid pregnancy or fathering children.
Exclusion criteria
* An unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to baseline. * Concurrent conditions and history of other diseases * Any current and/or history of serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including application of study cream and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data. For example: * Clinically significant or uncontrolled cardiovascular disease, including unstable angina, acute myocardial infarction or stroke within 6 months from Day 1 of study cream application, New York Heart Association Class III or IV congestive heart failure, and arrhythmia requiring therapy or uncontrolled hypertension (blood pressure \> 150/90 mm Hg) unless approved by the medical monitor/sponsor. * Current and/or history of malignancy in the 5 years preceding the baseline visit, except for adequately treated, nonmetastatic nonmelanoma skin cancer. * Current and/or history of arterial or venous thrombosis, including DVT and PE. * Current and/or history of active tuberculosis or current and/or history of latent tuberculosis unless adequately treated. * Any of the following clinical laboratory test results at screening: 1. Hemoglobin \< 100 g/L (\< 10 g/dL) 2. Liver function tests: * AST or ALT ≥ 2.5 × ULN * Total bilirubin \> 1.5 × ULN with the exception of Gilbert disease. c. Estimated glomerular filtration rate \< 30 mL/min/1.73 m2 (using the CKD Epidemiology Collaboration equation). d. Positive serology test results for HIV antibody. e. Any other clinically significant laboratory result that, in the opinion of the investigator, poses a significant risk to the participant. * Use of any of the following treatments within the indicated washout period before baseline: 1. 5 half-lives or 12 weeks, whichever is longer - biologic agents (eg, dupilumab). 2. 4 weeks - systemic corticosteroids or adrenocorticotropic hormone analogues, cyclosporine, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (eg, mycophenolate or tacrolimus). 3. 2 weeks - immunizations with live-attenuated vaccines; sedating antihistamines, unless on long-term stable regimen (nonsedating antihistamines are permitted). Note: Live-attenuated vaccines are not recommended during the CT period. Note: COVID-19 vaccination is allowed. 4. 1 week - use of other topical treatments for AD (other than bland emollients, eg, Aveeno® creams, ointments, sprays, soap substitutes), such as topical antipruritics (eg, doxepin cream), corticosteroids, calcineurin inhibitors, PDE4 inhibitors, coal tar (shampoo), antibiotics, or antibacterial cleansing body wash/soap. Note: Diluted sodium hypochlorite bleach baths are allowed as long as they do not exceed 2 baths per week and their frequency remains the same throughout the study. * Previously received systemic or topical JAK inhibitors (eg, ruxolitinib, tofacitinib, baricitinib, filgotinib, lestaurtinib, pacritinib). * Ultraviolet light therapy or prolonged exposure to natural or artificial sources of UV radiation (eg, sunlight or tanning booth) within 2 weeks prior to the baseline visit and/or intention to have such exposure during the study, which is thought by the investigator to potentially impact the participant's AD. * Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before baseline with another investigational medication or current enrollment in another investigational drug protocol. * Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before baseline with a strong CYP3A4 inhibitor. * Inability to draw blood for PK analysis from any nonlesional areas. * Known allergy or reaction to any component of the study cream formulation. * In the opinion of the investigator unable or unlikely to comply with the administration schedule and study evaluations. Further
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | up to 462 days | An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study cream. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first application of study cream and up to 30 days after the last application of study cream. |
| Number of Participants With ≥Grade 3 TEAEs | up to 462 days | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was drug related. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first application of study cream and up to 30 days after the last application of study cream. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment 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 treatment indicated. Grade 5: fatal. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CT Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing | up to Week 8 | Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Erythrocyte mean corpuscular volume and mean platelet volume were measured in femtoliters. |
| CT Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Value of Low, Normal, High, Low and High, and Missing | up to Week 8 | Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Erythrocytes were measured in 10\^12/Liter. |
| CT Period: Number of Participants With a Worst Abnormal Post-Baseline Hematocrit Value of Low, Normal, High, Low and High, and Missing | up to Week 8 | Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Hematocrit was measured in liters of red blood cells per liter of blood (L/L). |
| CT Period: Number of Participants With a Worst Abnormal Post-Baseline Hemoglobin Value of Low, Normal, High, Low and High, and Missing | up to Week 8 | Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Hemoglobin was measured in grams per liter. |
| LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Hemoglobin Value of Low, Normal, High, Low and High, and Missing | from Week 9 up to Week 52 (44 weeks) | Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Hemoglobin was measured in grams per liter. |
| LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | from Week 9 up to Week 52 (44 weeks) | Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils, and platelets were measured in 10\^9 cells per liter. |
| LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | from Week 9 up to Week 52 (44 weeks) | Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Basophils (baso)/leukocytes (leuko), eosinophils (eosino)/leukocytes, lymphocytes/leukocytes, monocytes/leukocytes, and neutrophils (neutro)/leukocytes were measured as a percentage. |
| LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing | from Week 9 up to Week 52 (44 weeks) | Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Erythrocyte mean corpuscular volume and mean platelet volume were measured in femtoliters. |
| LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Value of Low, Normal, High, Low and High, and Missing | from Week 9 up to Week 52 (44 weeks) | Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Erythrocytes were measured in 10\^12/Liter. |
| LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Hematocrit Value of Low, Normal, High, Low and High, and Missing | from Week 9 up to Week 52 (44 weeks) | Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Hematocrit was measured in liters of red blood cells per liter of blood (L/L). |
| CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | up to Week 8 | Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST), creatine kinase (CK), and lactate dehydrogenase (LDH) were measured in units per liter. |
| CT Period: Number of Participants With a Worst Abnormal Post-Baseline Albumin Value of Low, Normal, High, Low and High, and Missing | up to Week 8 | Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Albumin was measured in grams per liter. |
| CT Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing | up to Week 8 | Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Bilirubin, creatinine, and direct bilirubin were measured in micromoles per liter (µmol/L). |
| CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | up to Week 8 | Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils, and platelets were measured in 10\^9 cells per liter. |
| CT Period: Number of Participants With a Worst Abnormal Post-Baseline Creatinine Clearance Value of Low, Normal, High, Low and High, and Missing | up to Week 8 | Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Creatinine clearance was measured in milliliters per minute per 1.73 square meters of body surface area (mL/min/1.73 m\^2). |
| LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | from Week 9 up to Week 52 (44 weeks) | Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. ALT, ALP, AST, CK, and LDH were measured in units per liter. |
| LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Albumin Value of Low, Normal, High, Low and High, and Missing | from Week 9 up to Week 52 (44 weeks) | Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Albumin was measured in grams per liter. |
| LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing | from Week 9 up to Week 52 (44 weeks) | Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Bilirubin, creatinine, and direct bilirubin were measured in micromoles per liter (µmol/L). |
| LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | from Week 9 up to Week 52 (44 weeks) | Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Calcium, chloride, glucose, phosphate, potassium, sodium, and urea nitrogen were measured in millimoles per liter (mmol/L). |
| LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Creatinine Clearance Value of Low, Normal, High, Low and High, and Missing | from Week 9 up to Week 52 (44 weeks) | Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Creatinine clearance was measured in milliliters per minute per 1.73 square meters of body surface area (mL/min/1.73 m\^2). |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 8, 44, and 52 | Baseline; Weeks 8, 44, and 52 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Change From Baseline in Pulse at Weeks 8, 44, and 52 | Baseline; Weeks 8, 44, and 52 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Change From Baseline in Respiration Rate at Weeks 8, 44, and 52 | Baseline; Weeks 8, 44, and 52 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Change From Baseline in Body Temperature at Weeks 8, 44, and 52 | Baseline; Weeks 8, 44, and 52 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Change From Baseline in Height at Weeks 8 and 52 | Baseline; Weeks 8 and 52 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Change From Baseline in Weight at Weeks 8 and 52 | Baseline; Weeks 8 and 52 | Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Plasma Concentration of Ruxolitinib | prior to study cream application at Weeks 2 and 4 | Blood samples were drawn to assess plasma concentration. |
| CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | up to Week 8 | Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Calcium, chloride, glucose, phosphate, potassium, sodium, and urea nitrogen were measured in millimoles per liter (mmol/L). |
| CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | up to Week 8 | Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Basophils (baso)/leukocytes (leuk), eosinophils (eosino)/leukocytes, lymphocytes/leukocytes, monocytes/leukocytes, and neutrophils (neutro)/leukocytes were measured as a percentage. |
Countries
Canada, Poland, United States
Participant flow
Pre-assignment details
This study was conducted at 25 study centers in the United States and Canada.
Participants by arm
| Arm | Count |
|---|---|
| Ruxolitinib 1.5% Cream BID Participants applied ruxolitinib 1.5% cream twice daily (BID) to all areas identified for treatment at Baseline regardless of whether or not the lesion(s) improved for 8 weeks (Continuous Treatment Period). Participants who completed the Week 8 assessments with no safety concerns and with a percentage of body surface area (%BSA) affected by atopic dermatitis of no greater than 20% continued into the Long-term Safety (LTS) Period. During the 44 weeks of the LTS Period, the treatment regimen continued to be ruxolitinib 1.5% cream BID; however, participants only treated active atopic dermatitis lesions. | 103 |
| Total | 103 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 44-week Long-term Safety Period | Lack of Efficacy | 1 |
| 44-week Long-term Safety Period | Lost to Follow-up | 12 |
| 44-week Long-term Safety Period | Physician Decision | 2 |
| 44-week Long-term Safety Period | Protocol-specified Withdrawal Criterion Met | 1 |
| 44-week Long-term Safety Period | Unable to Attend the Follow-up Visit | 1 |
| 44-week Long-term Safety Period | Withdrawal by Sponsor | 2 |
| 44-week Long-term Safety Period | Withdrawal by Subject | 12 |
| 8-week Continuous Treatment (CT) Period | Lack of Efficacy | 2 |
| 8-week Continuous Treatment (CT) Period | Lost to Follow-up | 5 |
| 8-week Continuous Treatment (CT) Period | Protocol-specified Withdrawal Criterion Met | 1 |
| 8-week Continuous Treatment (CT) Period | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Ruxolitinib 1.5% Cream BID |
|---|---|
| Age, Continuous | 14.3 years STANDARD_DEVIATION 1.64 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 23 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 80 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized Asian | 18 Participants |
| Race/Ethnicity, Customized Asian, Dominican, Cuban | 1 Participants |
| Race/Ethnicity, Customized Asian/White | 1 Participants |
| Race/Ethnicity, Customized Black/African-American | 31 Participants |
| Race/Ethnicity, Customized East Indian | 1 Participants |
| Race/Ethnicity, Customized Middle Eastern (Arab) | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian/Pacific Islander | 2 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants |
| Race/Ethnicity, Customized White/Black | 1 Participants |
| Race/Ethnicity, Customized White/Caucasian | 46 Participants |
| Sex: Female, Male Female | 56 Participants |
| Sex: Female, Male Male | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 103 |
| other Total, other adverse events | 20 / 103 |
| serious Total, serious adverse events | 2 / 103 |
Outcome results
Primary
Number of Participants With ≥Grade 3 TEAEs
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was drug related. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first application of study cream and up to 30 days after the last application of study cream. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment 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 treatment indicated. Grade 5: fatal.
Time frame: up to 462 days
Population: Full Analysis Set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ruxolitinib 1.5% Cream BID | Number of Participants With ≥Grade 3 TEAEs | 3 Participants |
Primary
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study cream. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first application of study cream and up to 30 days after the last application of study cream.
Time frame: up to 462 days
Population: Full Analysis Set: all participants who applied ruxolitinib cream at least once
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ruxolitinib 1.5% Cream BID | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 42 Participants |
Secondary
Change From Baseline in Body Temperature at Weeks 8, 44, and 52
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline; Weeks 8, 44, and 52
Population: Full Analysis Set. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | Change From Baseline in Body Temperature at Weeks 8, 44, and 52 | Baseline | 36.5 degrees Celsius | Standard Deviation 0.42 |
| Ruxolitinib 1.5% Cream BID | Change From Baseline in Body Temperature at Weeks 8, 44, and 52 | Change from Baseline at Week 8 | 0.0 degrees Celsius | Standard Deviation 0.4 |
| Ruxolitinib 1.5% Cream BID | Change From Baseline in Body Temperature at Weeks 8, 44, and 52 | Change from Baseline at Week 44 | 0.1 degrees Celsius | Standard Deviation 0.43 |
| Ruxolitinib 1.5% Cream BID | Change From Baseline in Body Temperature at Weeks 8, 44, and 52 | Change from Baseline at Week 52 | 0.1 degrees Celsius | Standard Deviation 0.44 |
Secondary
Change From Baseline in Height at Weeks 8 and 52
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline; Weeks 8 and 52
Population: Full Analysis Set. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | Change From Baseline in Height at Weeks 8 and 52 | Baseline | 165.1 centimeters | Standard Deviation 9.88 |
| Ruxolitinib 1.5% Cream BID | Change From Baseline in Height at Weeks 8 and 52 | Change from Baseline at Week 8 | 0.7 centimeters | Standard Deviation 1.2 |
| Ruxolitinib 1.5% Cream BID | Change From Baseline in Height at Weeks 8 and 52 | Change from Baseline at Week 52 | 3.1 centimeters | Standard Deviation 3.31 |
Secondary
Change From Baseline in Pulse at Weeks 8, 44, and 52
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline; Weeks 8, 44, and 52
Population: Full Analysis Set. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | Change From Baseline in Pulse at Weeks 8, 44, and 52 | Baseline | 78.8 beats per minute | Standard Deviation 12.71 |
| Ruxolitinib 1.5% Cream BID | Change From Baseline in Pulse at Weeks 8, 44, and 52 | Change from Baseline at Week 8 | 0.5 beats per minute | Standard Deviation 11.23 |
| Ruxolitinib 1.5% Cream BID | Change From Baseline in Pulse at Weeks 8, 44, and 52 | Change from Baseline at Week 44 | -0.6 beats per minute | Standard Deviation 11.69 |
| Ruxolitinib 1.5% Cream BID | Change From Baseline in Pulse at Weeks 8, 44, and 52 | Change from Baseline at Week 52 | -0.4 beats per minute | Standard Deviation 12.18 |
Secondary
Change From Baseline in Respiration Rate at Weeks 8, 44, and 52
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline; Weeks 8, 44, and 52
Population: Full Analysis Set. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | Change From Baseline in Respiration Rate at Weeks 8, 44, and 52 | Baseline | 16.1 breaths per minute | Standard Deviation 2.5 |
| Ruxolitinib 1.5% Cream BID | Change From Baseline in Respiration Rate at Weeks 8, 44, and 52 | Change from Baseline at Week 8 | 0.7 breaths per minute | Standard Deviation 6.91 |
| Ruxolitinib 1.5% Cream BID | Change From Baseline in Respiration Rate at Weeks 8, 44, and 52 | Change from Baseline at Week 44 | -0.5 breaths per minute | Standard Deviation 1.91 |
| Ruxolitinib 1.5% Cream BID | Change From Baseline in Respiration Rate at Weeks 8, 44, and 52 | Change from Baseline at Week 52 | -0.1 breaths per minute | Standard Deviation 1.88 |
Secondary
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 8, 44, and 52
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline; Weeks 8, 44, and 52
Population: Full Analysis Set. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 8, 44, and 52 | Baseline, SBP | 112.7 millimeters of mercury (mmHg) | Standard Deviation 11.14 |
| Ruxolitinib 1.5% Cream BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 8, 44, and 52 | Change from Baseline at Week 8, SBP | 0.6 millimeters of mercury (mmHg) | Standard Deviation 10.01 |
| Ruxolitinib 1.5% Cream BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 8, 44, and 52 | Change from Baseline at Week 44, SBP | -1.4 millimeters of mercury (mmHg) | Standard Deviation 11.1 |
| Ruxolitinib 1.5% Cream BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 8, 44, and 52 | Change from Baseline at Week 52, SBP | 1.0 millimeters of mercury (mmHg) | Standard Deviation 10.77 |
| Ruxolitinib 1.5% Cream BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 8, 44, and 52 | Baseline, DBP | 71.0 millimeters of mercury (mmHg) | Standard Deviation 8.03 |
| Ruxolitinib 1.5% Cream BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 8, 44, and 52 | Change from Baseline at Week 8, DBP | 0.2 millimeters of mercury (mmHg) | Standard Deviation 8.35 |
| Ruxolitinib 1.5% Cream BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 8, 44, and 52 | Change from Baseline at Week 44, DBP | 0.1 millimeters of mercury (mmHg) | Standard Deviation 9.31 |
| Ruxolitinib 1.5% Cream BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 8, 44, and 52 | Change from Baseline at Week 52, DBP | 1.0 millimeters of mercury (mmHg) | Standard Deviation 8.04 |
Secondary
Change From Baseline in Weight at Weeks 8 and 52
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline; Weeks 8 and 52
Population: Full Analysis Set. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | Change From Baseline in Weight at Weeks 8 and 52 | Baseline | 65.0 kilograms | Standard Deviation 18.25 |
| Ruxolitinib 1.5% Cream BID | Change From Baseline in Weight at Weeks 8 and 52 | Change from Baseline at Week 8 | 0.9 kilograms | Standard Deviation 3.11 |
| Ruxolitinib 1.5% Cream BID | Change From Baseline in Weight at Weeks 8 and 52 | Change from Baseline at Week 52 | 3.8 kilograms | Standard Deviation 7.01 |
Secondary
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Albumin Value of Low, Normal, High, Low and High, and Missing
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Albumin was measured in grams per liter.
Time frame: up to Week 8
Population: Full Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Albumin Value of Low, Normal, High, Low and High, and Missing | Low | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Albumin Value of Low, Normal, High, Low and High, and Missing | Normal | 23 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Albumin Value of Low, Normal, High, Low and High, and Missing | High | 80 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Albumin Value of Low, Normal, High, Low and High, and Missing | Low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Albumin Value of Low, Normal, High, Low and High, and Missing | Missing | 0 Participants |
Secondary
CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST), creatine kinase (CK), and lactate dehydrogenase (LDH) were measured in units per liter.
Time frame: up to Week 8
Population: Full Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | ALT, low | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | ALT, normal | 100 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | ALT, high | 3 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | ALT, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | ALT, missing | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | ALP, low | 14 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | ALP, normal | 89 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | ALP, high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | ALP, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | ALP, missing | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | AST, low | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | AST, normal | 102 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | AST, high | 1 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | AST, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | AST, missing | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | CK, low | 3 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | CK, normal | 77 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | CK, high | 22 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | CK, low and high | 1 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | CK, missing | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | LDH, low | 7 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | LDH, normal | 91 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | LDH, high | 5 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | LDH, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | LDH, missing | 0 Participants |
Secondary
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Basophils (baso)/leukocytes (leuk), eosinophils (eosino)/leukocytes, lymphocytes/leukocytes, monocytes/leukocytes, and neutrophils (neutro)/leukocytes were measured as a percentage.
Time frame: up to Week 8
Population: Full Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Basophils/leukocytes, low | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Basophils/leukocytes, normal | 84 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Basophils/leukocytes, high | 18 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Basophils/leukocytes, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Basophils/leukocytes, missing | 1 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Eosinophils/leukocytes, low | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Eosinophils/leukocytes, normal | 73 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Eosinophils/leukocytes, high | 29 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Eosinophils/leukocytes, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Eosinophils/leukocytes, missing | 1 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Lymphocytes/leukocytes, low | 29 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Lymphocytes/leukocytes, normal | 47 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Lymphocytes/leukocytes, high | 22 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Lymphocytes/leukocytes, low and high | 4 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Lymphocytes/leukocytes, missing | 1 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Monocytes/leukocytes, low | 3 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Monocytes/leukocytes, normal | 94 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Monocytes/leukocytes, high | 5 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Monocytes/leukocytes, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Monocytes/leukocytes, missing | 1 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Neutrophils/leukocytes, low | 6 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Neutrophils/leukocytes, normal | 66 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Neutrophils/leukocytes, high | 30 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Neutrophils/leukocytes, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Neutrophils/leukocytes, missing | 1 Participants |
Secondary
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils, and platelets were measured in 10\^9 cells per liter.
Time frame: up to Week 8
Population: Full Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Basophils, normal | 94 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Basophils, high | 1 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Basophils, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Basophils, missing | 8 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Eosinophils, low | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Eosinophils, normal | 83 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Eosinophils, high | 19 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Eosinophils, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Eosinophils, missing | 1 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Leukocytes, low | 18 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Leukocytes, normal | 83 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Leukocytes, high | 1 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Leukocytes, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Leukocytes, missing | 1 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Lymphocytes, low | 7 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Lymphocytes, normal | 95 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Lymphocytes, high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Lymphocytes, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Lymphocytes, missing | 1 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Monocytes, low | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Monocytes, normal | 92 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Monocytes, high | 10 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Monocytes, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Monocytes, missing | 1 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Neutrophils, low | 13 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Neutrophils, normal | 87 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Neutrophils, high | 2 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Neutrophils, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Neutrophils, missing | 1 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Platelets, low | 5 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Platelets, normal | 75 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Platelets, high | 21 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Platelets, low and high | 1 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Platelets, missing | 1 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Basophils, low | 0 Participants |
Secondary
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Bilirubin, creatinine, and direct bilirubin were measured in micromoles per liter (µmol/L).
Time frame: up to Week 8
Population: Full Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing | Bilirubin, low | 31 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing | Bilirubin, normal | 68 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing | Bilirubin, high | 4 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing | Bilirubin, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing | Bilirubin, missing | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing | Creatinine, low | 54 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing | Creatinine, normal | 49 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing | Creatinine, high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing | Creatinine, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing | Creatinine, missing | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing | Direct bilirubin, low | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing | Direct bilirubin, normal | 4 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing | Direct bilirubin, high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing | Direct bilirubin, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing | Direct bilirubin, missing | 99 Participants |
Secondary
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Calcium, chloride, glucose, phosphate, potassium, sodium, and urea nitrogen were measured in millimoles per liter (mmol/L).
Time frame: up to Week 8
Population: Full Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Calcium, low | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Calcium, normal | 84 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Calcium, high | 19 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Calcium, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Calcium, missing | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Chloride, low | 52 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Chloride, normal | 51 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Chloride, high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Chloride, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Chloride, missing | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Glucose, low | 13 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Glucose, normal | 86 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Glucose, high | 4 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Glucose, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Glucose, missing | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Phosphate, low | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Phosphate, normal | 82 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Phosphate, high | 21 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Phosphate, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Phosphate, missing | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Potassium, low | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Potassium, normal | 80 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Potassium, high | 23 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Potassium, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Potassium, missing | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Sodium, low | 8 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Sodium, normal | 93 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Sodium, high | 1 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Sodium, low and high | 1 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Sodium, missing | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Urea nitrogen, low | 2 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Urea nitrogen, normal | 86 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Urea nitrogen, high | 15 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Urea nitrogen, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Urea nitrogen, missing | 0 Participants |
Secondary
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Creatinine Clearance Value of Low, Normal, High, Low and High, and Missing
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Creatinine clearance was measured in milliliters per minute per 1.73 square meters of body surface area (mL/min/1.73 m\^2).
Time frame: up to Week 8
Population: Full Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Creatinine Clearance Value of Low, Normal, High, Low and High, and Missing | Low | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Creatinine Clearance Value of Low, Normal, High, Low and High, and Missing | Normal | 2 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Creatinine Clearance Value of Low, Normal, High, Low and High, and Missing | High | 4 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Creatinine Clearance Value of Low, Normal, High, Low and High, and Missing | Low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Creatinine Clearance Value of Low, Normal, High, Low and High, and Missing | Missing | 97 Participants |
Secondary
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Erythrocyte mean corpuscular volume and mean platelet volume were measured in femtoliters.
Time frame: up to Week 8
Population: Full Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing | Erythrocyte mean corpuscular volume, low | 3 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing | Erythrocyte mean corpuscular volume, normal | 88 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing | Erythrocyte mean corpuscular volume, high | 11 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing | Erythrocyte mean corpuscular volume, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing | Erythrocyte mean corpuscular volume, missing | 1 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing | Mean platelet volume, low | 5 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing | Mean platelet volume, normal | 97 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing | Mean platelet volume, high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing | Mean platelet volume, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing | Mean platelet volume, missing | 1 Participants |
Secondary
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Value of Low, Normal, High, Low and High, and Missing
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Erythrocytes were measured in 10\^12/Liter.
Time frame: up to Week 8
Population: Full Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Value of Low, Normal, High, Low and High, and Missing | Low | 14 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Value of Low, Normal, High, Low and High, and Missing | Normal | 66 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Value of Low, Normal, High, Low and High, and Missing | High | 22 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Value of Low, Normal, High, Low and High, and Missing | Low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Value of Low, Normal, High, Low and High, and Missing | Missing | 1 Participants |
Secondary
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Hematocrit Value of Low, Normal, High, Low and High, and Missing
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Hematocrit was measured in liters of red blood cells per liter of blood (L/L).
Time frame: up to Week 8
Population: Full Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Hematocrit Value of Low, Normal, High, Low and High, and Missing | Low | 2 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Hematocrit Value of Low, Normal, High, Low and High, and Missing | Normal | 88 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Hematocrit Value of Low, Normal, High, Low and High, and Missing | High | 12 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Hematocrit Value of Low, Normal, High, Low and High, and Missing | Low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Hematocrit Value of Low, Normal, High, Low and High, and Missing | Missing | 1 Participants |
Secondary
CT Period: Number of Participants With a Worst Abnormal Post-Baseline Hemoglobin Value of Low, Normal, High, Low and High, and Missing
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Hemoglobin was measured in grams per liter.
Time frame: up to Week 8
Population: Full Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Hemoglobin Value of Low, Normal, High, Low and High, and Missing | Low | 19 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Hemoglobin Value of Low, Normal, High, Low and High, and Missing | Normal | 79 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Hemoglobin Value of Low, Normal, High, Low and High, and Missing | High | 4 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Hemoglobin Value of Low, Normal, High, Low and High, and Missing | Low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | CT Period: Number of Participants With a Worst Abnormal Post-Baseline Hemoglobin Value of Low, Normal, High, Low and High, and Missing | Missing | 1 Participants |
Secondary
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Albumin Value of Low, Normal, High, Low and High, and Missing
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Albumin was measured in grams per liter.
Time frame: from Week 9 up to Week 52 (44 weeks)
Population: LTS Evaluable Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Albumin Value of Low, Normal, High, Low and High, and Missing | Low | 0 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Albumin Value of Low, Normal, High, Low and High, and Missing | Normal | 19 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Albumin Value of Low, Normal, High, Low and High, and Missing | High | 69 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Albumin Value of Low, Normal, High, Low and High, and Missing | Low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Albumin Value of Low, Normal, High, Low and High, and Missing | Missing | 4 Participants |
Secondary
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. ALT, ALP, AST, CK, and LDH were measured in units per liter.
Time frame: from Week 9 up to Week 52 (44 weeks)
Population: LTS Evaluable Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | ALT, low | 5 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | ALT, normal | 78 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | ALT, high | 5 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | ALT, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | ALT, missing | 4 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | ALP, low | 14 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | ALP, normal | 69 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | ALP, high | 5 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | ALP, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | ALP, missing | 4 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | AST, low | 2 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | AST, normal | 82 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | AST, high | 4 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | AST, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | AST, missing | 4 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | CK, low | 5 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | CK, normal | 56 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | CK, high | 27 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | CK, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | CK, missing | 4 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | LDH, low | 9 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | LDH, normal | 72 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | LDH, high | 7 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | LDH, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline ALT, ALP, AST, CL, and LDH Value of Low, Normal, High, Low and High, and Missing | LDH, missing | 4 Participants |
Secondary
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Basophils (baso)/leukocytes (leuko), eosinophils (eosino)/leukocytes, lymphocytes/leukocytes, monocytes/leukocytes, and neutrophils (neutro)/leukocytes were measured as a percentage.
Time frame: from Week 9 up to Week 52 (44 weeks)
Population: LTS Evaluable Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Lymphocytes/leukocytes, normal | 29 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Basophils/leukocytes, low | 0 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Basophils/leukocytes, normal | 67 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Basophils/leukocytes, high | 21 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Basophils/leukocytes, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Basophils/leukocytes, missing | 4 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Eosinophils/leukocytes, low | 0 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Eosinophils/leukocytes, normal | 49 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Eosinophils/leukocytes, high | 39 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Eosinophils/leukocytes, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Eosinophils/leukocytes, missing | 4 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Lymphocytes/leukocytes, low | 39 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Lymphocytes/leukocytes, high | 18 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Lymphocytes/leukocytes, low and high | 2 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Lymphocytes/leukocytes, missing | 4 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Monocytes/leukocytes, low | 13 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Monocytes/leukocytes, normal | 68 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Monocytes/leukocytes, high | 7 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Monocytes/leukocytes, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Monocytes/leukocytes, missing | 4 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Neutrophils/leukocytes, low | 8 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Neutrophils/leukocytes, normal | 43 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Neutrophils/leukocytes, high | 37 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Neutrophils/leukocytes, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Baso/Leuko, Eosino/Leuko, Lymphocyte/Leuko, Monocyte/Leuko, and Neutro/Leuko Value of Low, Normal, High, Low and High, and Missing | Neutrophils/leukocytes, missing | 4 Participants |
Secondary
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils, and platelets were measured in 10\^9 cells per liter.
Time frame: from Week 9 up to Week 52 (44 weeks)
Population: Long-term Safety (LTS) Evaluable Population: all participants who applied ruxolitinib cream at least once during the LTS Period
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Basophils, low | 0 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Basophils, normal | 85 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Basophils, high | 2 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Basophils, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Basophils, missing | 5 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Eosinophils, low | 0 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Eosinophils, normal | 63 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Eosinophils, high | 25 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Eosinophils, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Eosinophils, missing | 4 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Leukocytes, low | 20 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Leukocytes, normal | 62 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Leukocytes, high | 6 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Leukocytes, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Leukocytes, missing | 4 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Lymphocytes, low | 5 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Lymphocytes, normal | 82 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Lymphocytes, high | 1 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Lymphocytes, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Lymphocytes, missing | 4 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Monocytes, low | 0 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Monocytes, normal | 75 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Monocytes, high | 13 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Monocytes, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Monocytes, missing | 4 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Neutrophils, low | 12 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Neutrophils, normal | 66 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Neutrophils, high | 10 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Neutrophils, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Neutrophils, missing | 4 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Platelets, low | 3 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Platelets, normal | 60 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Platelets, high | 25 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Platelets, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Basophil, Eosinophil, Leukocyte, Lymphocyte, Monocyte, Neutrophil, and Platelet Value of Low, Normal, High, Low and High, and Missing | Platelets, missing | 4 Participants |
Secondary
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Bilirubin, creatinine, and direct bilirubin were measured in micromoles per liter (µmol/L).
Time frame: from Week 9 up to Week 52 (44 weeks)
Population: LTS Evaluable Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing | Bilirubin, low | 40 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing | Bilirubin, normal | 43 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing | Bilirubin, high | 5 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing | Bilirubin, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing | Bilirubin, missing | 4 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing | Creatinine, low | 58 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing | Creatinine, normal | 30 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing | Creatinine, high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing | Creatinine, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing | Creatinine, missing | 4 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing | Direct bilirubin, low | 0 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing | Direct bilirubin, normal | 4 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing | Direct bilirubin, high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing | Direct bilirubin, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Bilirubin, Creatinine, and Direct Bilirubin Value of Low, Normal, High, Low and High, and Missing | Direct bilirubin, missing | 88 Participants |
Secondary
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Calcium, chloride, glucose, phosphate, potassium, sodium, and urea nitrogen were measured in millimoles per liter (mmol/L).
Time frame: from Week 9 up to Week 52 (44 weeks)
Population: LTS Evaluable Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Calcium, low | 2 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Calcium, normal | 72 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Calcium, high | 14 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Calcium, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Calcium, missing | 4 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Chloride, low | 54 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Chloride, normal | 34 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Chloride, high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Chloride, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Chloride, missing | 4 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Glucose, low | 12 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Glucose, normal | 72 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Glucose, high | 4 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Glucose, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Glucose, missing | 4 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Phosphate, low | 1 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Phosphate, normal | 62 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Phosphate, high | 25 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Phosphate, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Phosphate, missing | 4 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Potassium, low | 1 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Potassium, normal | 66 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Potassium, high | 21 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Potassium, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Potassium, missing | 4 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Sodium, low | 17 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Sodium, normal | 70 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Sodium, high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Sodium, low and high | 1 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Sodium, missing | 4 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Urea nitrogen, low | 4 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Urea nitrogen, normal | 65 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Urea nitrogen, high | 19 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Urea nitrogen, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Calcium, Chloride, Glucose, Phosphate, Potassium, Sodium, and Urea Nitrogen Value of Low, Normal, High, Low and High, and Missing | Urea nitrogen, missing | 4 Participants |
Secondary
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Creatinine Clearance Value of Low, Normal, High, Low and High, and Missing
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Creatinine clearance was measured in milliliters per minute per 1.73 square meters of body surface area (mL/min/1.73 m\^2).
Time frame: from Week 9 up to Week 52 (44 weeks)
Population: LTS Evaluable Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Creatinine Clearance Value of Low, Normal, High, Low and High, and Missing | Low | 0 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Creatinine Clearance Value of Low, Normal, High, Low and High, and Missing | Normal | 10 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Creatinine Clearance Value of Low, Normal, High, Low and High, and Missing | High | 11 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Creatinine Clearance Value of Low, Normal, High, Low and High, and Missing | Low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Creatinine Clearance Value of Low, Normal, High, Low and High, and Missing | Missing | 71 Participants |
Secondary
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Erythrocyte mean corpuscular volume and mean platelet volume were measured in femtoliters.
Time frame: from Week 9 up to Week 52 (44 weeks)
Population: LTS Evaluable Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing | Erythrocyte mean corpuscular volume, low | 4 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing | Erythrocyte mean corpuscular volume, normal | 56 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing | Erythrocyte mean corpuscular volume, high | 28 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing | Erythrocyte mean corpuscular volume, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing | Erythrocyte mean corpuscular volume, missing | 4 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing | Mean platelet volume, low | 11 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing | Mean platelet volume, normal | 77 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing | Mean platelet volume, high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing | Mean platelet volume, low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Mean Corpuscular Volume and Mean Platelet Volume Value of Low, Normal, High, Low and High, and Missing | Mean platelet volume, missing | 4 Participants |
Secondary
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Value of Low, Normal, High, Low and High, and Missing
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Erythrocytes were measured in 10\^12/Liter.
Time frame: from Week 9 up to Week 52 (44 weeks)
Population: LTS Evaluable Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Value of Low, Normal, High, Low and High, and Missing | Low | 19 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Value of Low, Normal, High, Low and High, and Missing | Normal | 42 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Value of Low, Normal, High, Low and High, and Missing | High | 26 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Value of Low, Normal, High, Low and High, and Missing | Low and high | 1 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Erythrocyte Value of Low, Normal, High, Low and High, and Missing | Missing | 4 Participants |
Secondary
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Hematocrit Value of Low, Normal, High, Low and High, and Missing
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Hematocrit was measured in liters of red blood cells per liter of blood (L/L).
Time frame: from Week 9 up to Week 52 (44 weeks)
Population: LTS Evaluable Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Hematocrit Value of Low, Normal, High, Low and High, and Missing | Low | 2 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Hematocrit Value of Low, Normal, High, Low and High, and Missing | Normal | 49 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Hematocrit Value of Low, Normal, High, Low and High, and Missing | High | 37 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Hematocrit Value of Low, Normal, High, Low and High, and Missing | Low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Hematocrit Value of Low, Normal, High, Low and High, and Missing | Missing | 4 Participants |
Secondary
LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Hemoglobin Value of Low, Normal, High, Low and High, and Missing
Low: participants with ≥1 low value but not any high values. High: participants with ≥1 high value but not any low values. Normal: participants without any low or high values. Low and high: participants with both low and high values. Hemoglobin was measured in grams per liter.
Time frame: from Week 9 up to Week 52 (44 weeks)
Population: LTS Evaluable Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Hemoglobin Value of Low, Normal, High, Low and High, and Missing | Low | 26 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Hemoglobin Value of Low, Normal, High, Low and High, and Missing | Normal | 55 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Hemoglobin Value of Low, Normal, High, Low and High, and Missing | High | 7 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Hemoglobin Value of Low, Normal, High, Low and High, and Missing | Low and high | 0 Participants |
| Ruxolitinib 1.5% Cream BID | LTS Period: Number of Participants With a Worst Abnormal Post-Baseline Hemoglobin Value of Low, Normal, High, Low and High, and Missing | Missing | 4 Participants |
Secondary
Plasma Concentration of Ruxolitinib
Blood samples were drawn to assess plasma concentration.
Time frame: prior to study cream application at Weeks 2 and 4
Population: Pharmacokinetic (PK) Population: all participants who applied ruxolitinib cream at least once and provided at least 1 postbaseline PK sample (1 PK measurement). Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ruxolitinib 1.5% Cream BID | Plasma Concentration of Ruxolitinib | Week 2 | 21.4 nanomoles per liter (nM) | Standard Deviation 27.7 |
| Ruxolitinib 1.5% Cream BID | Plasma Concentration of Ruxolitinib | Week 4 | 24.6 nanomoles per liter (nM) | Standard Deviation 38.2 |