Official Title: “A Randomized, Double-Blinded Study of Epiceram Versus Elidel in Pediatric Subjects With Mild to Moderate Atopic Dermatitis”

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 repair cream designed to deliver special epidermal lipids to the top layers of the skin in order to correct skin barrier abnormalities found in atopic dermatitis. Epiceram does not contain corticosteroids or other conventional anti-inflammatory components and represents a novel class of skin barrier repair therapy for inflammatory skin disease.

The objective of this study is to determine whether Epiceram is a safe and effective therapy for mild to moderate atopic dermatitis and whether it may serve as an alternative to Elidel therapy.

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2007

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 corticosteroids and calcineurin inhibitors, such as Elidel and Protopic. The chronic use of topical corticosteroids is limited by side effects including skin atrophy, striae, and even HPA axis suppression. The long-term effects of skin immunosuppression with calcineurin inhibitors are unknown and although not proven, a theoretical risk of skin cancer exists. Novel therapies for atopic dermatitis that avoid immunosupression are greatly needed.

Epiceram, a newly FDA-approved medical device is a topical barrier repair cream designed to deliver special epidermal lipids to the top layers of the skin in order to correct skin barrier abnormalities found in atopic dermatitis. Epiceram does not contain corticosteroids or other conventional anti-inflammatory components and represents a novel class of skin barrier repair therapy for inflammatory skin disease. The objective of this study is to determine whether Epiceram is a safe and effective therapy for mild to moderate atopic dermatitis and whether it may serve as an alternative to Elidel therapy.

Intervention(s) in this Clinical Trial

• Drug: Elidel(R) (pimecrolimus 1%)
• Device: EpiCeram(R) -ceramide based barrier repair cream

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Elidel(r)
• Experimental: Epiceram(r)

Primary Measures

• The primary efficacy outcome is the change in mean Eczema Area and Severity Index (EASI) score in both groups.
  • Time Frame: 4 weeks
    Safety Issue?: No

Secondary Measures

• Percent of subjects reaching clear or almost clear on Investigator's Global Assessment (IGA) at week 4.
  • Time Frame: 4 weeks
    Safety Issue?: No
• Change in mean capacitance in lesional and nonlesional skin at target site
  • Time Frame: 4 weeks
    Safety Issue?: No
• Change in mean transepidermal water loss (TEWL) in lesional and nonlesional skin at target site
  • Time Frame: 4 weeks
    Safety Issue?: No
• Change in pruritus score measured with a visual analog scale
  • Time Frame: 4 weeks
    Safety Issue?: No
• Comparison of baseline and Week 4 Children's Dermatitis Life Quality Index (CDLQI)
  • Time Frame: 4 weeks
    Safety Issue?: No

Inclusion Criteria:

• 1. Males or females of any race 2 - 12 years of age.
• 2. Diagnosis of atopic dermatitis on the basis of the criteria defined by Hanifin and Rajka (Hanifin, 1980).
• 3. Rajka-Langeland Severity Index score of mild to moderate (Rajka, 1989).
• 4. At least one antecubital or popliteal fossa must be affected at the time of enrollment to serve as a target site.

Exclusion Criteria:

• 1. Subjects with severe AD as determined by the Rajka-Langeland Severity Index (Rajka 1989).
• 2. Disease severity requiring medium-potency topical steroid medication to treat their atopic dermatitis more than 1 week per month.
• 3. Subjects with unstable or uncontrolled medical conditions that could require intensive treatment during the course of the study.
• 4. Subjects who require greater than 2.0 mg/day inhaled or intranasal corticosteroids.
• 5. Subjects who are currently participating in or, within the past 28 days, have participated in another study using an investigational drug.
• 6. Subjects with a history of allergy or hypersensitivity to Epiceram, Elidel, or ingredients therein, including fragrances.
• 7. Active infection of any type at the start of the study.
• 8. Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
• 9. Subjects must have not used any topical or systemic therapy during the washout periods.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 2 Years

Maximum Age for this Clinical Trial: 12 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Ceragenix Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Eric Simpson, MD Principal Investigator Oregon Health and Science University  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00460083

Study ID Number: CGXP - 060674/ IRB00002569

ClinicalTrials.gov Identifier: NCT00460083

Health Authority: United States: Institutional Review Board