Epiceram Versus Elidel for Treatment of Mild to Moderate Atopic Dermatitis

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00460083
Study type	Interventional
Source	Ceragenix Pharmaceuticals
Contact
Status	Completed
Phase	Phase 4
Start date	April 2007
Completion date	February 2008

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See also
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