Epiceram™ Device Versus Mid-Strength Topical Steroid (Fluticasone Propionate 0.05%) for Treatment of Atopic Dermatitis

Study Overview
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Brief Summary
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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 corticosteroids or other anti-inflammatory drugs. The objective of the present study is to demonstrate the safety and efficacy of EpiCeram ™ in the treatment of moderate to severe atopic dermatitis as compared to mid-strength topical steroid cream following twice daily dosing for four weeks in pediatric patients with AD. The potential benefit to patients lies in the potential for EpiCeram ™ to provide restoration of the normal skin barrier as shown in previous studies and eliminate or reduce the requirement for supplemental topical steroid administration.

Official Title
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Prospective, Randomized, Investigator-Blind, Controlled, Pilot Study Comparing Effect of Epiceram™ Device vs Standard of Care Therapy of Mid-Strength Topical Steroid (Fluticasone Propionate 0.05%) in Treatment of Atopic Dermatitis in Pediatric Subjects

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Device: Epiceram(r)
* Drug: Fluticasone Propionate 0.05%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 18 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: Cutivate(r)<br>Topical mid-strength steroid | Drug: Fluticasone Propionate 0.05%<br>* Topical mid-strength steroid<br>|
| Experimental: EpiCeram(r)<br>EpiCeram(r) topical barrier repair cream. | Device: Epiceram(r)<br>* Topical barrier repair emulsion cream<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the mean Severity Scoring for Atopic Dermatitis (SCORAD) |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects reaching clear or almost clear on Investigator's Global Assessment (IGA) |  | 4 weeks | 
| Change in assessments of Pruritus and sleep habits |  | week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atopic, Dermatitis, eczema, skin barrier, ceramide, topical, inflamation, steroid, SCORAD, glucocorticoids, EpiCeram, Cutivate, fluticasone