Tofacitinib Ointment For Atopic Dermatitis (Atopic Eczema)

Pfizer

Status and phase

Completed

Phase 2

Conditions

Dermatitis, Atopic

Treatments

Drug: Tofacitinib ointment 20mg/g

Drug: Placebo ointment (Vehicle)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02001181

A3921214

Details and patient eligibility

About

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.

Enrollment

69 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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