Comparison of the Efficacy and Safety of Two Topical Creams for Pediatric Atopic Dermatitis
Phase 4
Completed
- Conditions
- Atopic Dermatitis
- Interventions
- Device: EpiCeram Skin Barrier Emulsion
- Registration Number
- NCT00828412
- Lead Sponsor
- Promius Pharma, LLC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 EpiCeram Skin Barrier Emulsion EpiCeram Skin Barrier Emulsion 2 Desonide Cream 0.05% Desonide Cream 0.05%
- Primary Outcome Measures
Name Time Method Change From Baseline in Three Item Severity Score 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Wake Forest University Health Sciences
🇺🇸Winston Salem, North Carolina, United States
Dermatology Research Associates
🇺🇸Cincinnati, Ohio, United States
University of Texas
🇺🇸Houston, Texas, United States
National Jewish Health
🇺🇸Denver, Colorado, United States
Northwestern University
🇺🇸Chicago, Illinois, United States