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Withdrawn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: Placebo for Product 0405Drug: Product 0405
- Registration Number
- NCT02176551
- 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
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- WITHDRAWN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 Placebo for Product 0405 Placebo for Product 0405 Topical Placebo for Product 0405 Product 0405 Product 0405 Topical active investigational Product 0405
- Primary Outcome Measures
Name Time Method Statistically significant superiority of the test Product 0405 to the vehicle 28 days Statistically significant superiority of the test Product 0405 to the vehicle
- 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 Incidence of success based on the Investigators Static Global Assessment and the Clinical Signs and Symptoms (erythema, scaling) at the end of treatment.