Comparison of the Efficacy and Safety of Two Topical Creams for Pediatric Atopic Dermatitis
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ClinicalTrials.gov Identifier: NCT00828412 |
Recruitment Status :
Completed
First Posted : January 26, 2009
Results First Posted : December 9, 2013
Last Update Posted : January 30, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Atopic Dermatitis | Device: EpiCeram Skin Barrier Emulsion Drug: Desonide Cream 0.05% | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (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 |
Study Start Date : | March 2009 |
Actual Primary Completion Date : | August 2009 |
Actual Study Completion Date : | August 2009 |

Arm | Intervention/treatment |
---|---|
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 |
- Change From Baseline in Three Item Severity Score [ Time Frame: Baseline to 6 weeks ]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.

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Ages Eligible for Study: | 3 Months to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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): NCT00828412
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 |
Study Director: | Joanne Fraser, PhD | Promius Pharma, LLC |
Responsible Party: | Promius Pharma, LLC |
ClinicalTrials.gov Identifier: | NCT00828412 |
Other Study ID Numbers: |
EPC0801 |
First Posted: | January 26, 2009 Key Record Dates |
Results First Posted: | December 9, 2013 |
Last Update Posted: | January 30, 2017 |
Last Verified: | December 2016 |
Dermatitis, Atopic Dermatitis Eczema Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn |
Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Desonide Anti-Inflammatory Agents |