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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fougera Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01232543
First received: October 28, 2010
Last updated: April 9, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention Phase
Atopic Dermatitis
Drug: Product 0405
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Evaluation of the Adrenal Suppression Potential of Product 0405 in the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric Subjects

Further study details as provided by Fougera Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin demonstrating the absence or presence of adrenal suppression. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 114
Study Start Date: November 2010
Study Completion Date: November 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Product 0405
Topical Active Investigational Product 0405
Drug: Product 0405
Product 0405 will be administered topically, twice daily for 28 days.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   3 Months to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01232543

Locations
United States, New York
Fougera Pharmaceuticals Inc.
Melville, New York, United States, 11747
Sponsors and Collaborators
Fougera Pharmaceuticals Inc.
Investigators
Study Director: Kathleen Ocasio, CCRA Fougera Pharmaceuticals Inc.
  More Information

No publications provided

Responsible Party: Fougera Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01232543     History of Changes
Other Study ID Numbers: 0405-01-04
Study First Received: October 28, 2010
Last Updated: April 9, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Fougera Pharmaceuticals Inc.:
Atopic Dermatitis

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014