This study is being conducted to evaluate the efficacy and safety of 3 different application rates of topically applied Crisaborole ointment 2% over vehicle in adults with mild to moderate atopic dermatitis (AD). In each subject four application areas will be identified. Each subject will receive 4 treatments: the 3 different application rates of the active treatment and the vehicle. The areas will be randomly assigned to treatment with topical Crisaborole ointment 2% and vehicle, once daily, for 2 weeks, without occlusion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
31
Crisaborole ointment 2% (application rate A, B, C) for 15 days (double blind)
Placebo ointment (vehicle)
Innovaderm Research Inc.
Montreal, Quebec, Canada
Total Signs Score (TSS)
Change from baseline in TSS in target lesions treated with crisaborole ointment 2% or vehicle at Day 15. Total Signs Score (TSS) of the lesion is the assessment of the severity of erythema, edema/papulation, excoriation, and lichenification. Each of these subscales is scored independently using the 4-point severity scale with a value range from 0 to 3; 0 is the minimum (best) and 3 is the maximum (worst). The total score is computed by the sum of each subscale where the total ranges from the minimum 0 (best) to the maximum 12 (worst).
Time frame: Baseline, Day 15
Total Signs Score (TSS)
Change from baseline in lesion severity as measured by TSS at Day 8 and Day 15 Total Signs Score (TSS) of the lesion is the assessment of the severity of erythema, edema/papulation, excoriation, and lichenification. Each of these subscales is scored independently using the 4-point severity scale with a value range from 0 to 3; 0 is the minimum (best) and 3 is the maximum (worst). The total score is computed by the sum of each subscale where the total ranges from the minimum 0 (best) to the maximum 12 (worst).
Time frame: Baseline, Day 8, Day 15
Target Area Assessment (TAA)
Change from baseline in TAA at Day 8 and Day 15
Time frame: Change from baseline in TAA at Day 8 and Day 15.
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