This will be an open label study of ruxolitinib topical cream applied to 2 - 20% BSA in patients with active, stable plaque psoriasis.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Ruxolitinib 1.5% cream BID for 28 days
Unnamed facility
Fridley, Minnesota, United States
Unnamed facility
Rochester, New York, United States
Unnamed facility
Austin, Texas, United States
Unnamed facility
College Station, Texas, United States
Number of Treatment of Emergent Adverse Events
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment
Time frame: Approximately 3 months
Pharmacokinetics Parameter : Skin Flux of INCB018424
The INCB018424 skin flux was estimated from the overall mean steady-state plasma concentrations for each subject in this study and the estimated systemic clearance of INCB018424 following oral-dose administration in another study.
Time frame: Days 1, 4, 8, 15, 22, and 28-30
Pharmacokinetics Parameter: Bioavailability of INCB018424
The INCB018424 bioavailability was estimated from the overall mean steady-state plasma concentrations for each subject in this study and the estimated systemic clearance of INCB018424 following oral-dose administration in another study.
Time frame: Approximately one month: Days 1, 4, 8, 15, 22, and 28
Pharmacokinetics Parameter: Plasma Concentrated Steady State (CSS) of INCB018424
All observed INCB018424 plasma concentrations from Days 8, 15, 22, and 28 were averaged to obtain an overall mean exposure for each subject. Samples were taken pre-dose and approximately one hour post-dose.
Time frame: Approximately one month: Days 1, 4, 8, 15, 22, and 28
Psioriatic Lesion Severity: Change in Total Lesion Score for the Target Lesion Compared to Baseline
Changes in total lesion scores were compared to baseline score. Lesions were compared between active treated areas INCB018424 and control areas of the same subject (within-subject comparisons) using one sample t-test. Total lesion score was calculated as the sum of the scores for Thickness (T), erythema (E), and scaling (S) for the target and control lesions. All individual scores use a 5-point scale ranging from 0 (none) to 4 (severe) with increasing score reflecting increased lesion severity. These ratings are then added to create a total score ranging from 0 to 12.
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Time frame: Approximately 2 months (Days 1, 8, 15, 22, 28 and up to an additional 28 day Follow-Up)
Mean Change in Psoriatic Lesion Area
The target and control lesion areas were determined in an objective manner on Day 1 and Day 28 based on a tracing of the perimeter of the lesions on transparency film and measurement of the area.
Time frame: Days 1 and 28
Mean Change in Physicians Global Assessment Score
The PGA was an overall assessment of each participant's plaque psoriasis. The assessment was recorded using a scale that ranged from 0 (clear) to 6 (most severe) in whole-unit increments. Note that, for analysis purposes, the scale was adjusted to range from 1 (clear) to 7 (most severe) to allow for the evaluation of mean scores.
Time frame: Approximately 2 months: Days 1, 8, 15, 22, 28 and follow-up approximately one month later