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

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

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.

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.