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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

764 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Dermatitis, Atopic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AN2728 Topical Ointment, 2%

AN2728 Topical Ointment, 2%, applied twice daily for up to 28 days

Group Type EXPERIMENTAL

AN2728 Topical Ointment, 2%

Intervention Type DRUG

Matching vehicle control

Matching vehicle control, applied twice daily for up to 28 days

Group Type PLACEBO_COMPARATOR

Matching vehicle control

Intervention Type DRUG

Interventions

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AN2728 Topical Ointment, 2%

Intervention Type DRUG

Matching vehicle control

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No