Safety Study Evaluating the Adrenal Suppression Potential of Product 0405 in Pediatric Subjects With Atopic Dermatitis (0405-01-04)

April 9, 2012 updated by: Fougera Pharmaceuticals Inc.

An Open-Label Evaluation of the Adrenal Suppression Potential of Product 0405 in the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric Subjects

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Melville, New York, United States, 11747
        • Fougera Pharmaceuticals Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Product 0405
Topical Active Investigational Product 0405
Drug: Product 0405
Product 0405 will be administered topically, twice daily for 28 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin demonstrating the absence or presence of adrenal suppression.
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fougera Pharmaceuticals Inc.

Investigators

  • Study Director: Kathleen Ocasio, CCRA, Fougera Pharmaceuticals Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

October 28, 2010

First Submitted That Met QC Criteria

November 1, 2010

First Posted (Estimate)

November 2, 2010

Study Record Updates

Last Update Posted (Estimate)

April 11, 2012

Last Update Submitted That Met QC Criteria

April 9, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0405-01-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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