Tofacitinib Ointment For Atopic Dermatitis (Atopic Eczema)

Dermatitis, Atopic Clinical Trial

Official title:

A Phase 2a, Multi-site, Randomized, Double-blind, Vehicle-controlled, Parallel-group Study Of The Pilot Efficacy, Safety, Tolerability, And Pharmacokinetics Of 2% Tofacitinib Ointment In Subjects With Mild To Moderate Atopic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02001181
• Other study ID #: A3921214
• Status: Completed
• Phase: Phase 2
• First received: November 27, 2013
• Last updated: September 16, 2015
• Start date: December 2013
• Est. completion date: September 2014

Study information

• Verified date: September 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Tofacitinib ointment 20mg/g
Tofacitinib ointment 20mg/g twice daily (BID) for 4 weeks
• Placebo ointment (Vehicle)
Placebo ointment (vehicle) twice daily (BID) for 4 weeks

Locations

Country	Name	City	State
Canada	Innovaderm Research Inc.	Montreal	Quebec
Canada	SKiN Centre for Dermatology	Peterborough	Ontario
Canada	Centre de Recherche Dermatologique du Quebec metropolitain	Quebec
Canada	The Centre for Dermatology	Richmond Hill	Ontario
Canada	K. Papp Clinical Research	Waterloo	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (pre-dose on Day 1) and Week 4	No
Secondary	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.	Week 4	No
Secondary	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.	Baseline (pre-dose on Day 1) and Week 4	No
Secondary	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.	Baseline (pre-dose on Day 1) and Week 4	No
Secondary	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.	Baseline (pre-dose on Day 1) and Week 4	No

External Links

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