Status:
COMPLETED
Epiceram Versus Elidel for Treatment of Mild to Moderate Atopic Dermatitis
Lead Sponsor:
Ceragenix Pharmaceuticals
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
2-12 years
Phase:
PHASE4
Brief Summary
Atopic dermatitis (AD) is a common skin disease that has increased in prevalence worldwide two- to threefold over the last 50 years. Epiceram, a newly FDA-approved medical device is a topical barrier ...
Detailed Description
Atopic dermatitis (AD) is a common skin disease that has increased in prevalence worldwide two- to threefold over the last 50 years. Current standard of care for atopic dermatitis includes topical cor...
Eligibility Criteria
Inclusion
- Males or females of any race 2 - 12 years of age.
- Diagnosis of atopic dermatitis on the basis of the criteria defined by Hanifin and Rajka (Hanifin, 1980).
- Rajka-Langeland Severity Index score of mild to moderate (Rajka, 1989).
- At least one antecubital or popliteal fossa must be affected at the time of enrollment to serve as a target site.
Exclusion
- Subjects with severe AD as determined by the Rajka-Langeland Severity Index (Rajka 1989).
- Disease severity requiring medium-potency topical steroid medication to treat their atopic dermatitis more than 1 week per month.
- Subjects with unstable or uncontrolled medical conditions that could require intensive treatment during the course of the study.
- Subjects who require greater than 2.0 mg/day inhaled or intranasal corticosteroids.
- Subjects who are currently participating in or, within the past 28 days, have participated in another study using an investigational drug.
- Subjects with a history of allergy or hypersensitivity to Epiceram, Elidel, or ingredients therein, including fragrances.
- Active infection of any type at the start of the study.
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
- Subjects must have not used any topical or systemic therapy during the washout periods.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00460083
Start Date
April 1 2007
End Date
February 1 2008
Last Update
February 6 2008
Active Locations (2)
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1
UCSD
San Diego, California, United States
2
OHSU
Portland, Oregon, United States