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 |
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.
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
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