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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01232543
Recruitment Status : Completed
First Posted : November 2, 2010
Last Update Posted : April 11, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Product 0405 Phase 2

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2010
Primary Completion Date : August 2011
Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

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

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Fougera Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01232543     History of Changes
Other Study ID Numbers: 0405-01-04
First Posted: November 2, 2010    Key Record Dates
Last Update Posted: April 11, 2012
Last Verified: April 2012

Keywords provided by Fougera Pharmaceuticals Inc.:
Atopic Dermatitis

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