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

Completed · Phase 3

Conditions studied: Dermatitis, Atopic

In brief

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.

Key facts

Study ID

NCT02118766

Run by

Pfizer

People needed

763

Starts

2014-03-01

Expected to finish

2015-04-01

Last updated by the study team

2017-03-06

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Anacor Investigational Site — Stockbridge, Georgia, United States

Full record on ClinicalTrials.gov

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