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

Fougera Pharmaceuticals

Status and phase: Withdrawn; Phase 3

Conditions: Atopic Dermatitis

Treatments: Drug: Placebo for Product 0405; Drug: Product 0405

Study type: Interventional

Funder types: Industry

Identifiers

NCT02176538

0405-01-05

Details and patient eligibility

About

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

Full description

Treatment medication will be administered topically twice daily for 28 days

Sex: All

Ages: 3 months to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Product 0405

Experimental group

Description:

Topical active investigational Product 0405

Treatment:

Drug: Product 0405

Placebo for Product 0405

Placebo Comparator group

Description:

Topical Placebo for Product 0405

Treatment:

Drug: Placebo for Product 0405