Study Comparing Product 0405 to a Vehicle Control in the Treatment of Mild to Moderate Atopic Dermatitis in Pediatric Subjects

Phase 3

Withdrawn

• Conditions: Atopic Dermatitis
• Interventions: Drug: Product 0405; Drug: Placebo for Product 0405

• Registration Number: NCT02176538
• Lead Sponsor: Fougera Pharmaceuticals Inc.

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of product 0405 in pediatric subjects with Mild to Moderate Atopic Dermatitis.

Detailed Description

Treatment medication will be administered topically twice daily for 28 days

Study Timeline

• Study Start: 2012-06
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2014-06
• Study First Submitted: 2014-06-17
• Study First Submitted QC: 2014-06-26
• Last Update Submitted: 2014-06-26
• Study First Posted: 2014-06-27
• Last Update Posted: 2014-06-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Clinical diagnosis of Atopic Dermatitis
• Good health with the exception of Atopic Dermatitis
• Percent body surface area minimum requirements

Exclusion Criteria

• Subjects who are pregnant, nursing or planning a pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Product 0405	Product 0405	Topical active investigational Product 0405
Placebo for Product 0405	Placebo for Product 0405	Topical Placebo for Product 0405

Primary Outcome Measures

Name	Time	Method
Statistically significant superiority of the test Product 0405 to the vehicle	28 days

Secondary Outcome Measures

Name	Time	Method
Incidence of success based on the Investigators Static Global Assessment and the Clinical Signs and Symptoms (erythema, scaling) at the end of treatment.	28 days