Comparison of the Efficacy and Safety of Two Topical Creams for Pediatric Atopic Dermatitis
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
1 other identifier
interventional
100
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2009
Shorter than P25 for phase_4
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2009
CompletedFirst Posted
Study publicly available on registry
January 26, 2009
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedResults Posted
Study results publicly available
December 9, 2013
CompletedJanuary 30, 2017
December 1, 2016
5 months
January 21, 2009
September 17, 2013
December 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Three Item Severity Score
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.
Baseline to 6 weeks
Study Arms (2)
1
ACTIVE COMPARATOREpiCeram Skin Barrier Emulsion
2
ACTIVE COMPARATORDesonide Cream 0.05%
Interventions
Eligibility Criteria
You may qualify if:
- at least 3 months of age and less than 13 years of age
- atopic dermatitis of moderate severity
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Joanne Fraser
- Organization
- Promius Pharma
Study Officials
- STUDY DIRECTOR
Joanne Fraser, PhD
Promius Pharma, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2009
First Posted
January 26, 2009
Study Start
March 1, 2009
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
January 30, 2017
Results First Posted
December 9, 2013
Record last verified: 2016-12