Epiceram Versus Elidel for Treatment of Mild to Moderate Atopic Dermatitis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: Elidel(R) (pimecrolimus 1%)
* Device: EpiCeram(R) -ceramide based barrier repair cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Elidel(r)<br> | Drug: Elidel(R) (pimecrolimus 1%)<br> <br> |
| Experimental: Epiceram(r)<br> | Device: EpiCeram(R) -ceramide based barrier repair cream<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy outcome is the change in mean Eczema Area and Severity Index (EASI) score in both groups. |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of subjects reaching clear or almost clear on Investigator's Global Assessment (IGA) at week 4. |  | 4 weeks | 
| Change in mean capacitance in lesional and nonlesional skin at target site |  | 4 weeks | 
| Change in mean transepidermal water loss (TEWL) in lesional and nonlesional skin at target site |  | 4 weeks | 
| Change in pruritus score measured with a visual analog scale |  | 4 weeks | 
| Comparison of baseline and Week 4 Children's Dermatitis Life Quality Index (CDLQI) |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atopic Dermatitis, eczema, dermatitis, skin barrier, barrier repair, ceramide, physiologic lipid, pruritus, Elidel, Epiceram, topical steroid