Status:
COMPLETED
Epiceram™ Device Versus Mid-Strength Topical Steroid (Fluticasone Propionate 0.05%) for Treatment of Atopic Dermatitis
Lead Sponsor:
Ceragenix Pharmaceuticals
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
6-18 years
Phase:
PHASE4
Brief Summary
Novel therapies for AD that avoid immunosuppression and potential carcinogensis are needed. EpiCeram™ , a topical cream, represents a novel class of therapy for skin disorders that does not contain co...
Eligibility Criteria
Inclusion
- Subjects willing to provide written informed consent (i.e. assent with parental/guardian consent for ages \> 7 to 18 years and parental consent for ages 6 months to 7 years) to participate in the study
- Males or Females
- Age: 6 months to 18 years
- Diagnosis of Moderate to Severe Atopic Dermatitis (AD) on the basis of criteria defined by the Rajka-Langland Severity Index
Exclusion
- Subjects with mild AD as defined by the Rajka-Laneland Severity Index.
- Subjects having greater than 20% BSA as measured by SCORAD "Extent" (A) score (total amount of body surface area requiring application of either Cutivate® or EpiCeram® exceeds 20%)
- Subjects with unstable or uncontrolled medical conditions that could require intensive treatment during the course of the study.
- Subjects who require greater than 2mg per day of inhaled or intranasal steroids.
- Subjects who are currently participating in, or have participated in another investigational drug/device trial within the past month.
- Subjects with known allergy to or hypersensitivity to EpiCeram™ or Fluticasone or Cetaphil.
- Active infection of any type at the start of the study.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT00616538
Start Date
December 1 2006
Last Update
February 15 2008
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.