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

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer

Criteria

Inclusion Criteria:

• Males or females 2 years and older

• Has a clinical diagnosis of 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