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



Status:Completed
Conditions:Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:2 - Any
Updated:4/21/2016
Start Date:March 2014
End Date:April 2015

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A Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study of the Safety and Efficacy of AN2728 Topical Ointment, 2% in Children, Adolescents, and Adults (Ages 2 Years and Older) With Atopic Dermatitis

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.


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
We found this trial at
1
site
Henrico, Virginia 23294
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Henrico, VA
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