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

Fougera Pharmaceuticals Inc.

Overview

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

Treatment medication will be administered topically twice daily for 28 days

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Atopic Dermatitis

Interventions

Product 0405DRUG

Product 0405 will be administered topically twice daily for 28 days

Placebo for Product 0405DRUG

Placebo for Product 0405 will be administered topically twice daily for 28 days.

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 17 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Statistically significant superiority of the test Product 0405 to the vehicle

Time frame: 28 days

Secondary Outcomes

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

Time frame: 28 days

Data from ClinicalTrials.gov

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