Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

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

Resource links provided by NLM:

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 ]

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 ]

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.

Ages Eligible for Study:   3 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT01232543

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

Responsible Party: Fougera Pharmaceuticals Inc. Identifier: NCT01232543     History of Changes
Other Study ID Numbers: 0405-01-04
Study First Received: October 28, 2010
Last Updated: April 9, 2012

Keywords provided by Fougera Pharmaceuticals Inc.:
Atopic Dermatitis

Additional relevant MeSH terms:
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases processed this record on May 25, 2017