Safety Study Evaluating the Adrenal Suppression Potential of Product 0405 in Pediatric Subjects With Atopic Dermatitis

Phase 2

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: Product 0405

• Registration Number: NCT01232543
• Lead Sponsor: Fougera Pharmaceuticals Inc.

Brief Summary

The aim of the trial is to assess Adrenal Suppression potential when pediatric subjects are administered Product 0405 for the treatment of Atopic Dermatitis

Detailed Description

Treatment medication will be administered topically, twice a day for 4 weeks.

Study Timeline

• Study First Submitted: 2010-10-28
• Study Start: 2010-11
• Study First Submitted QC: 2010-11-01
• Study First Posted: 2010-11-02
• Primary Completion: 2011-08
• Study Completion: 2011-11
• Status Verified: 2012-04
• Disposition First Submitted: 2012-04-09
• Disposition First Submitted QC: 2012-04-09
• Last Update Submitted: 2012-04-09
• Disposition First Posted: 2012-04-11
• Last Update Posted: 2012-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Product 0405	Product 0405	Topical Active Investigational Product 0405

Primary Outcome Measures

Name	Time	Method
Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin demonstrating the absence or presence of adrenal suppression.	4 weeks

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.	4 weeks

Trial Locations

Locations (1)

Fougera Pharmaceuticals Inc.; 🇺🇸 Melville, New York, United States