Comparison of the Efficacy and Safety of Two Topical Creams for Pediatric Atopic Dermatitis
Information source: Promius Pharma, LLC
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atopic Dermatitis
Intervention: EpiCeram Skin Barrier Emulsion (Device); Desonide Cream 0.05% (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Promius Pharma, LLC Official(s) and/or principal investigator(s):
Joanne Fraser, PhD, Study Director, Affiliation: Promius Pharma, LLC
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.
Clinical Details
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 design: Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change from baseline in three item severity score
Secondary outcome: Change from baseline in SCORADPruritus severity score Sleep disturbance score Investigator global assessment Quality of life index
Eligibility
Minimum age: 3 Months.
Maximum age: 12 Years.
Gender(s): Both.
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
Locations and Contacts
National Jewish Health, Denver, Colorado 80206, United States
Northwestern University, Chicago, Illinois 60611, United States
Wake Forest University Health Sciences, Winston Salem, North Carolina 27157, United States
Dermatology Research Associates, Cincinnati, Ohio 45230, United States
University of Texas, Houston, Texas 77030, United States
Additional Information
Starting date: January 2009
Ending date: September 2009
Last updated: January 27, 2009
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