The study is being conducted to evaluate the efficacy, safety and tolerability of 2% tofacitinib ointment (20 mg/g) BID (twice daily) in subjects with mild to moderate atopic dermatitis compared to placebo (vehicle) BID for 4 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
69
Tofacitinib ointment 20mg/g twice daily (BID) for 4 weeks
Placebo ointment (vehicle) twice daily (BID) for 4 weeks
SKiN Centre for Dermatology
Peterborough, Ontario, Canada
The Centre for Dermatology
Richmond Hill, Ontario, Canada
K. Papp Clinical Research
Waterloo, Ontario, Canada
Innovaderm Research Inc.
Montreal, Quebec, Canada
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 4
The EASI quantifies the severity of a participant's atopic dermatitis based on both lesion severity and the percent of BSA affected. The EASI is a composite scoring by the atopic dermatitis clinical evaluator of the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of 4 body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of atopic dermatitis. What is reported is the percent change from baseline in EASI scores.
Time frame: Baseline (pre-dose on Day 1) and Week 4
Proportion of Participants Achieving Physician's Global Assessment (PGA) Response of Clear or Almost Clear at Week 4
The PGA score assesses the overall severity of atopic dermatitis. Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate, and severe, respectively) based on morphological descriptors.
Time frame: Week 4
Proportion of Participants With Response of Clear or Almost Clear and Greater Than or Equal to (>=) 2 Grade/Point Improvement From Baseline at Week 4
The PGA score assesses the overall severity of atopic dermatitis. Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate, and severe, respectively) based on morphological descriptors.
Time frame: Baseline (pre-dose on Day 1) and Week 4
Percent Change From Baseline in Body Surface Area (BSA) Efficacy at Week 4
The percent BSA with atopic dermatitis in a body region was determined by the number of handprints of atopic dermatitis skin in that region: head and neck, upper limbs, trunk including axillae, lower limbs including buttocks. In the handprint method, the full palmar hand of the participant (i.e., the participant's fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. What is reported is the percent change from baseline in BSA affected.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Centre de Recherche Dermatologique du Quebec metropolitain
Québec, Quebec, Canada
Time frame: Baseline (pre-dose on Day 1) and Week 4
Change From Baseline in the EASI Clinical Signs Severity Sum Score at Week 4
The EASI Clinical Signs Severity Sum Score was derived from the EASI. The Clinical Signs Severity Scores on the 4-point scale for dermatitis lesions were summed in each EASI body region. The sum of the Clinical Signs Severity Score in each EASI body region was then totaled across the 4 EASI body regions to provide an EASI Clinical Signs Severity Sum Score, which ranged from 0 to 48, with higher scores representing greater severity of atopic dermatitis.
Time frame: Baseline (pre-dose on Day 1) and Week 4