The study was double-blind, randomized, vehicle-controlled study with application of Ruxolitinib phosphate cream or vehicle cream in participants with stable plaque psoriasis applied once daily for 12 weeks without occlusive dressings. There were 4 treatment groups anticipated to have 50 participants in each.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
199
Cream with no active drug
Ruxolitinib phosphate cream
Unnamed facility
Hot Springs, Arkansas, United States
Unnamed facility
Absolute Change From Baseline in Total Lesion Score for All Treatable Psoriatic Lesions to Day 84
Total Lesion Score is calculated as the sum of component scores for erythema (E), scaling (S), and thickness (T) of the study-treated lesions taken together. Each component consists of ratings of 0=none, 1=mild, 2=moderate, 3=marked, and 4=severe such that total lesion score can vary in value from 0 to 12. A negative change from Baseline indicates improvement.
Time frame: From Baseline (Day 1) to Day 84
Absolute Change From Baseline in the Individual Lesion Scores for Lesion Thickness
Lesion thickness was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. A negative change from Baseline indicates improvement.
Time frame: From Baseline (Day 1) to Day 84
Absolute Change From Baseline in the Individual Lesion Scores for Lesion Erythema
Lesion erythema was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. A negative change from Baseline indicates improvement.
Time frame: From Baseline (Day 1) to Day 84
Absolute Change From Baseline in the Individual Lesion Scores for Lesion Scaling
Lesion scaling was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. A negative change from Baseline indicates improvement.
Time frame: From Baseline (Day 1) to Day 84
Percent Change From Baseline in the Individual Lesion Scores of Lesion Thickness
Lesion thickness was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. A negative percent change from Baseline indicates improvement in lesion.
Time frame: From Baseline (Day 1) to Day 84
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Los Angeles, California, United States
Unnamed facility
San Diego, California, United States
Unnamed facility
Santa Monica, California, United States
Unnamed facility
Vallejo, California, United States
Unnamed facility
New Haven, Connecticut, United States
Unnamed facility
Miami, Florida, United States
Unnamed facility
Ormond Beach, Florida, United States
Unnamed facility
Naperville, Illinois, United States
Unnamed facility
Wheaton, Illinois, United States
...and 18 more locations
Percent Change From Baseline in the Individual Lesion Scores of Lesion Erythema
Lesion erythema was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. A negative percent change from Baseline indicates improvement in lesion.
Time frame: From Baseline (Day 1) to Day 84
Percent Change From Baseline in the Individual Lesion Scores of Lesion Scaling
Lesion scaling was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. A negative percent change from Baseline indicates improvement in lesion.
Time frame: From Baseline (Day 1) to Day 84
Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Thickness at Day 84
Lesion thickness was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. Participants with individual lesion scores 0 (none) and 1 (mild) are reported in this outcome measure.
Time frame: Day 84
Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Erythema at Day 84
The individual lesion scores were calculated individually for thickness, erythema, and scaling. Lesion erythema was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. Participants with individual lesion scores 0 (none) and 1 (mild) are reported in this outcome measure. The LOCF method was used for analysis.
Time frame: Day 84
Percentage of Participants Achieving None (Score=0) and Mild (Score=1) in Lesion Scaling at Day 84
The individual lesion scores were calculated individually for thickness, erythema, and scaling. Lesion scaling was scored using a 5-point scale ranging from 0 to 4 where 0 is none or absent and 4 is severe lesion. Participants with individual lesion scores 0 (none) and 1 (mild) are reported in this outcome measure. The LOCF method was used for analysis.
Time frame: Day 84
Absolute Change From Baseline in the Percent Treatable Body Surface Area (BSA)
The lesion areas were estimated based on the Rule of Nines method for the entire skin surface; psoriatic disease activity and the percent BSA were calculated for the treatable areas (i.e., areas that excluded the scalp, face, and intertriginous areas). The BSA is calculated as follows: BSA (m\^²)=(\[Height(cm) x Weight(kg)\]/3600 )\^½. A negative change from Baseline indicates improvement.
Time frame: Baseline (Day 1) to Day 84
Absolute Change From Baseline in the Physician's Global Assessment (PGA) Score
The overall disease activity in the participants, a measure of the overall quality (erythema, scaling, and thickness) and extent (BSA) of plaques, was measured using the PGA. The PGA was an overall assessment of each participant's plaque psoriasis. The assessment was recorded using a 6-point scale ranging from 0 to 5 where 0 is 'Clear' (no evidence of disease) and 5 is 'very Severe' lesion. A negative change from Baseline indicates improvement. The ANCOVA method was used for analyses.
Time frame: Baseline (Day 1) to Day 84
Percent Change From Baseline in the PGA Score
The overall disease activity in the participants, a measure of the overall quality (erythema, scaling, and thickness) and extent (BSA) of plaques, was measured using the PGA. The PGA was an overall assessment of each participant's plaque psoriasis. The assessment was recorded using a 6-point scale ranging from 0 to 5 where 0 indicates 'Clear' (no evidence of disease) and 5 indicates 'very Severe' lesion. A negative percent change indicates improvement. The ANCOVA method was used for analyses.
Time frame: Baseline (Day 1) to Day 84
Percentage of Participants Achieving Clear (Score=0) and Almost Clear (Score=1) on the PGA
The overall disease activity in the participants, a measure of the overall quality (erythema, scaling, and thickness) and extent (BSA) of plaques, was measured using the PGA. The PGA was an overall assessment of each participant's plaque psoriasis. The assessment was recorded using a 6-point scale ranging from 0 to 5 where 0 indicates 'Clear' (no evidence of disease) and 5 indicates 'very Severe' lesion. Participants with individual lesion scores 0 (clear) and 1 (almost clear) are reported in this outcome measure.
Time frame: Day 84
Absolute Change From Baseline in the Psoriasis Area and Severity Index (PASI) Score
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring \[lower extremities, trunk (including stomach, chest, back), upper extremities, head\]; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by scale 0 (none) to 4 (severe). Final PASI is the sum of severity score for each area multiplied coverage for each section multiplied by area score weight of section (lower extremities: 0.4, trunk: 0.3, upper extremities: 0.2, head: 0.1). A negative change from baseline indicates improvement. The ANCOVA method was used for analyses.
Time frame: Baseline (Day 1) to Day 84
Percent Change From Baseline in the PASI Score
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring \[lower extremities, trunk (including stomach, chest, back), upper extremities, head\]; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by scale 0 (none) to 4 (severe). Final PASI is the sum of severity score for each area multiplied by coverage for each section multiplied by area score weight of section (lower extremities: 0.4, trunk: 0.3, upper extremities: 0.2, head: 0.1). A percent negative change from baseline indicates improvement in disease. The ANCOVA method was used for analyses.
Time frame: Baseline (Day 1) to Day 84
Percentage of Participants With Treatable Percent BSA ≥10% Achieving PASI 50%, PASI 75%, And PASI 90% Improvements From Baseline to Each Time Point
PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring \[lower extremities, trunk (including stomach, chest, back), upper extremities, head\]; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by scale 0 (none) to 4 (severe). Final PASI is the sum of severity score for each area\* multiplied by coverage for each section\* multiplied by area score weight of section (lower extremities: 0.4, trunk: 0.3, upper extremities: 0.2, head: 0.1). A negative percent change from Baseline indicates improvement. Data for Day 84 was imputed using the LOCF method.
Time frame: Baseline (Day 1) and Days 15, 28, 56, 84, and 112
Trough Plasma Concentrations [Minimum Concentration at Steady-state (Css,Min)] of Ruxolitinib Phosphate Prior to Study Drug Application at Steady State
Time frame: Pre-application on Days 1, 15, 28, 56, and 84