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Sponsored by: |
Promius Pharma, LLC |
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Information provided by: | Promius Pharma, LLC |
ClinicalTrials.gov Identifier: | NCT00828412 |
This study compares the effectiveness of two topical creams for atopic dermatitis in pediatric subjects. Subjects will be randomly assigned to use one of the two creams twice daily for 6 weeks or until clear.
Condition | Intervention | Phase |
---|---|---|
Atopic Dermatitis |
Device: EpiCeram Skin Barrier Emulsion Drug: Desonide Cream 0.05% |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Investigator-Blind, Six-Week, Parallel Group, Multicenter Pilot Study to Compare the Safety and Efficacy of EpiCeram Skin Barrier Emulsion and Desonide Cream 0.05% in the Twice Daily Treatment of Pediatric Subjects With Moderate Atopic Dermatitis |
Estimated Enrollment: | 100 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
EpiCeram Skin Barrier Emulsion
|
Device: EpiCeram Skin Barrier Emulsion
topical cream, twice daily, 6 weeks
|
2: Active Comparator
Desonide Cream 0.05%
|
Drug: Desonide Cream 0.05%
topical cream, twice daily, 6 weeks
|
Ages Eligible for Study: | 3 Months to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Colorado | |
National Jewish Health | Recruiting |
Denver, Colorado, United States, 80206 | |
Contact: Susan Leung 303-398-1549 | |
Principal Investigator: Mark Boguniewicz, MD | |
United States, Illinois | |
Northwestern University | Recruiting |
Chicago, Illinois, United States, 60611 | |
Contact: Sapna Patel, MD 773-327-3346 spatel@childrensmemorial.org | |
Principal Investigator: Amy Paller, MD | |
United States, North Carolina | |
Wake Forest University Health Sciences | Recruiting |
Winston Salem, North Carolina, United States, 27157 | |
Contact: Adele Clark 336-716-3775 | |
Principal Investigator: Joseph L Jorizzo, MD | |
United States, Ohio | |
Dermatology Research Associates | Recruiting |
Cincinnati, Ohio, United States, 45230 | |
Contact: Charlotte Clifton 513-232-2750 | |
Principal Investigator: Anne Lucky, MD | |
United States, Texas | |
University of Texas | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Maria Lopez 713-500-8266 | |
Principal Investigator: Adelaide Hebert, MD |
Study Director: | Joanne Fraser, PhD | Promius Pharma, LLC |
Responsible Party: | Promius Pharma, LLC ( Director Clinical Operations ) |
Study ID Numbers: | EPC0801 |
Study First Received: | January 21, 2009 |
Last Updated: | March 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00828412 History of Changes |
Health Authority: | United States: Institutional Review Board |
Anti-Inflammatory Agents Hypersensitivity Dermatitis, Atopic Genetic Diseases, Inborn Skin Diseases |
Hypersensitivity, Immediate Skin Diseases, Eczematous Desonide Skin Diseases, Genetic Dermatitis |
Anti-Inflammatory Agents Dermatitis, Atopic Skin Diseases Immune System Diseases Desonide Pharmacologic Actions Hypersensitivity |
Genetic Diseases, Inborn Therapeutic Uses Hypersensitivity, Immediate Skin Diseases, Eczematous Skin Diseases, Genetic Dermatitis |