Comparison of the Efficacy and Safety of Two Topical Creams for Pediatric Atopic Dermatitis
This study has been completed.
Sponsor:
Promius Pharma, LLC
Information provided by (Responsible Party):
Promius Pharma, LLC
ClinicalTrials.gov Identifier:
NCT00828412
First received: January 21, 2009
Last updated: October 14, 2013
Last verified: October 2013
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Purpose
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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
atopic dermatitis
MedlinePlus related topics:
Eczema
Drug Information available for:
Desonide
U.S. FDA Resources
Further study details as provided by Promius Pharma, LLC:
Primary Outcome Measures:
- Change From Baseline in Three Item Severity Score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]The average of the sum of scores for erythema, edema/papulation, and excoriation for two target lesions. Scoring on a scale of 0 to 3 (none to severe). Maximum score is 9.
| Enrollment: | 100 |
| Study Start Date: | March 2009 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
EpiCeram Skin Barrier Emulsion
|
Device: EpiCeram Skin Barrier Emulsion
topical cream, twice daily, 6 weeks
|
|
Active Comparator: 2
Desonide Cream 0.05%
|
Drug: Desonide Cream 0.05%
topical cream, twice daily, 6 weeks
|
Eligibility| Ages Eligible for Study: | 3 Months to 12 Years (Child) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- at least 3 months of age and less than 13 years of age
- atopic dermatitis of moderate severity
Exclusion Criteria:
- pregnant or lactating
- treatment of atopic dermatitis with topical product in the 14 days prior to Baseline
- treatment of atopic dermatitis with systemic product in the 30 days prior to Baseline
- serious or uncontrolled medical condition
- active infection
- significant use of inhaled, intranasal, or intraocular corticosteroid
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: NCT00828412
Please refer to this study by its ClinicalTrials.gov identifier: NCT00828412
Locations
| United States, Colorado | |
| National Jewish Health | |
| Denver, Colorado, United States, 80206 | |
| United States, Illinois | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| United States, North Carolina | |
| Wake Forest University Health Sciences | |
| Winston Salem, North Carolina, United States, 27157 | |
| United States, Ohio | |
| Dermatology Research Associates | |
| Cincinnati, Ohio, United States, 45230 | |
| United States, Texas | |
| University of Texas | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
Promius Pharma, LLC
Investigators
| Study Director: | Joanne Fraser, PhD | Promius Pharma, LLC |
More Information
| Responsible Party: | Promius Pharma, LLC |
| ClinicalTrials.gov Identifier: | NCT00828412 History of Changes |
| Other Study ID Numbers: | EPC0801 |
| Study First Received: | January 21, 2009 |
| Results First Received: | September 17, 2013 |
| Last Updated: | October 14, 2013 |
| Health Authority: | United States: Institutional Review Board |
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 Desonide Emollients Decanoic acid Anti-Inflammatory Agents Dermatologic Agents Antifungal Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on September 26, 2016