This study is a single-blind, intraindividual study to evaluate the efficacy of ruxolitinib 1.5 % cream in adult subjects with discoid lupus erythematosus.
This study is being conducted to evaluate the efficacy, safety and tolerability of ruxolitinib 1.5 % cream in adult subjects with discoid lupus erythematosus. Approximately 20 subjects with discoid lupus erythematosus will apply ruxolitinib 1.5% cream, twice daily on active lesions identified at Day 1 and any new lesions that appear, for 24 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
Topical application of Ruxolitinib 1.5% cream
Apply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion without occlusion on Area 1.
Apply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion under occlusion at night on Area 2.
INNO-6051 Site 03
Fredericton, New Brunswick, Canada
RECRUITINGInnovaderm Research Inc.
Montreal, Quebec, Canada
RECRUITINGChange from baseline in target lesion CLASI-A score
The CLASI-A (Cutaneous Lupus Area and Severity Index - Activity) quantifies disease activity based on scoring of erythema, scale/hypertrophy, mucous membrane involvement, acute hair loss, and non scarring alopecia. Change from baseline in target lesion CLASI-A score at Week 24 for the target DLE lesion treated with occlusion The CLASI-A score ranges from 0 to 70, with higher scores indicating more severe skin disease.
Time frame: Week 24
Change from baseline in target lesion CLASI-A score
The CLASI-A (Cutaneous Lupus Area and Severity Index - Activity) quantifies disease activity based on scoring of erythema, scale/hypertrophy, mucous membrane involvement, acute hair loss, and non scarring alopecia. Change from baseline in target lesion CLASI-A score at Week 24 for the target DLE lesion treated without occlusion. The CLASI-A score ranges from 0 to 70, with higher scores indicating more severe skin disease.
Time frame: Week 12, Week 24
Proportion of subjects with an erythema score of 0 (absent)
Proportion of subjects with an erythema score of 0 (absent) in 50% of all DLE lesions. Erythema will be assessed for each DLE lesion identified on Day 1 using the erythema component of the CLASI-A scale. The severity of erythema is scored on a 4-point scale ranging from 0 (absent) to 3.
Time frame: Week 24
Change from baseline in target lesion SADDLE-A
Change from baseline in target lesion SADDLE-A at Week 24 for the target DLE lesion treated with and without occlusion. Change from baseline in target lesion SADDLE-A score at Week 12 for the untreated target DLE lesion and the target DLE lesion treated with and without occlusion
Time frame: Week 12, Week 24
Proportion of subjects with a target lesion CLA-IGA score of 0 (clear) or 1 (almost clear)
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Apply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion under occlusion at night on Area 1.
Apply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion without occlusion on Area 2.
Proportion of subjects with a CLA-IGA score of 0 (clear) or 1 (almost clear) for all DLE lesions. The CLA-IGA is a 5 point scale that evaluates the severity of signs of the overall disease activity based on erythema, scale, edema/ infiltration, follicular involvement, and secondary changes.
Time frame: Week 24