Safety and Efficacy of AN2728 Topical Ointment, 2% in Children, Adolescents, and Adults (Aged 2 Years and Older) With Atopic Dermatitis

Pfizer

Status and phase

Completed

Phase 3

Conditions

Dermatitis, Atopic

Treatments

Drug: AN2728 Topical Ointment, 2%

Drug: Matching vehicle control

Study type

Interventional

Funder types

Industry

Identifiers

NCT02118792

AN2728-AD-302

Details and patient eligibility

About

The purpose of this study is to investigate the safety and efficacy of AN2728 Topical Ointment, 2% in children, adolescents, and adults (ages 2 years and older) with atopic dermatitis.

Enrollment

764 patients

Sex

All

Ages

2+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Males or females 2 years and older
Has a clinical diagnosis of Atopic Dermatitis (AD) according to the criteria of Hanifin and Rajka
Has AD involvement ≥ 5% Treatable %BSA (excluding the scalp)
Has an ISGA score of Mild (2) or Moderate (3) at Baseline/Day 1
All female subjects of childbearing potential must use acceptable methods of contraception from the Screening Visit continuously until 30 days after stopping study drug

Exclusion criteria

As determined by the study doctor, a medical history that may interfere with study objectives
Unstable AD or any consistent requirement for high potency topical corticosteroids
History of use of biologic therapy (including intravenous immunoglobulin)
Recent or anticipated concomitant use of systemic or topical therapies that might alter the course of AD
Recent or current participation in another research study
Females who are breastfeeding, pregnant, or with plans to get pregnant during the participation in the study
Participation in a previous AN2728 clinical trial