Tofacitinib Ointment For Atopic Dermatitis (Atopic Eczema)

Phase 2

Completed

Conditions: Dermatitis, Atopic

Interventions: Drug: Tofacitinib ointment 20mg/g
Drug: Placebo ointment (Vehicle)

Registration Number: NCT02001181

Lead Sponsor: Pfizer

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 69

Inclusion Criteria

Have a clinical diagnosis of atopic dermatitis (also known as atopic eczema) for at least 6 months prior to Day 1 that has been clinically stable for at least 1 month prior to Day 1 and is confirmed to be atopic dermatitis according to the criteria of Hanifin and Rajka.
Have a PGA score of 2 (mild) or 3 (moderate) at Day 1.
Have atopic dermatitis on the head (including face, but excluding hair bearing scalp), neck, trunk (excluding groin and genitals), or limbs including palms and soles covering at least 2% of total body surface area (BSA) and up to and including 20% of total BSA at Day 1. At least 2% of the total BSA will need to be on the head (including face, but excluding hair bearing scalp), neck, trunk (excluding groin and genitals), or limbs (excluding palms and soles).

Exclusion Criteria

Evidence of certain skin conditions/infections at baseline
Currently have atopic dermatitis on groin, genitals, palm or soles
Have certain laboratory abnormalities at baseline
Females who are pregnant, breastfeeding, or are of childbearing potential not using highly effective contraception

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group A	Tofacitinib ointment 20mg/g	-
Treatment B	Placebo ointment (Vehicle)	-

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 4	Baseline (pre-dose on Day 1) and 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.

Secondary Outcome Measures

Name	Time	Method
Proportion of Participants Achieving Physician's Global Assessment (PGA) Response of Clear or Almost Clear at Week 4	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.
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	Baseline (pre-dose on Day 1) and 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.
Change From Baseline in the EASI Clinical Signs Severity Sum Score at Week 4	Baseline (pre-dose on Day 1) and 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.
Percent Change From Baseline in Body Surface Area (BSA) Efficacy at Week 4	Baseline (pre-dose on Day 1) and 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.

Trial Locations

Locations (5): K. Papp Clinical Research
🇨🇦
Waterloo, Ontario, Canada
SKiN Centre for Dermatology
🇨🇦
Peterborough, Ontario, Canada
Innovaderm Research Inc.
🇨🇦
Montreal, Quebec, Canada
Centre de Recherche Dermatologique du Quebec metropolitain
🇨🇦
Quebec, Canada
The Centre for Dermatology
🇨🇦
Richmond Hill, Ontario, Canada