0405-01-04: Safety Study Evaluating the Adrenal Suppression Potential of Product 0405 in Pediatric Subjects With Atopic Dermatitis
Sponsor
Fougera Pharmaceuticals Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01232543
Collaborator
(none)
114
1
1
12
9.5
Study Details
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 |
|---|---|---|
|
Phase 2 |
Detailed Description
Treatment medication will be administered topically, twice a day for 4 weeks.
Study Design
Study Type:
Interventional
Actual Enrollment
:
114 participants
Allocation:
N/A
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
:
Nov 1, 2010
Actual Primary Completion Date
:
Aug 1, 2011
Actual Study Completion Date
:
Nov 1, 2011
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
- Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin demonstrating the absence or presence of adrenal suppression. [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. [4 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
3 Months
to 17 Years
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fougera Pharmaceuticals Inc. | Melville | New York | United States | 11747 |
Sponsors and Collaborators
- Fougera Pharmaceuticals Inc.
Investigators
- Study Director: Kathleen Ocasio, CCRA, Fougera Pharmaceuticals Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Fougera Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01232543
Other Study ID Numbers:
- 0405-01-04
First Posted:
Nov 2, 2010
Last Update Posted:
Apr 11, 2012
Last Verified:
Apr 1, 2012
Keywords provided by Fougera Pharmaceuticals Inc.
Additional relevant MeSH terms: