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Sponsored by: |
Ceragenix Pharmaceuticals |
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Information provided by: | Ceragenix Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00460083 |
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.
Condition | Intervention | Phase |
---|---|---|
Atopic Dermatitis |
Drug: Elidel(R) (pimecrolimus 1%) Device: EpiCeram(R) -ceramide based barrier repair cream |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blinded Study of Epiceram Versus Elidel in Pediatric Subjects With Mild to Moderate Atopic Dermatitis |
Enrollment: | 35 |
Study Start Date: | April 2007 |
Study Completion Date: | February 2008 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Elidel(r): Active Comparator | Drug: Elidel(R) (pimecrolimus 1%) |
Epiceram(r): Experimental | Device: EpiCeram(R) -ceramide based barrier repair cream |
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.
Ages Eligible for Study: | 2 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
UCSD | |
San Diego, California, United States | |
United States, Oregon | |
OHSU | |
Portland, Oregon, United States |
Principal Investigator: | Eric Simpson, MD | Oregon Health and Science University |
Responsible Party: | Ceragenix Pharmaceuticals Inc. ( Sr. Vice President, Research & Development ) |
Study ID Numbers: | CGXP - 060674/ IRB00002569 |
Study First Received: | April 11, 2007 |
Last Updated: | February 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00460083 History of Changes |
Health Authority: | United States: Institutional Review Board |
Atopic Dermatitis eczema dermatitis skin barrier barrier repair ceramide |
physiologic lipid pruritus Elidel Epiceram topical steroid |
Pruritus Anti-Inflammatory Agents Dermatitis, Atopic Immunologic Factors Skin Diseases Pimecrolimus Eczema Immunosuppressive Agents Hypersensitivity Genetic Diseases, Inborn |
Analgesics, Non-Narcotic Hypersensitivity, Immediate Skin Diseases, Eczematous Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Skin Diseases, Genetic Dermatitis |
Anti-Inflammatory Agents Dermatitis, Atopic Immunologic Factors Skin Diseases Immune System Diseases Physiological Effects of Drugs Pimecrolimus Immunosuppressive Agents Pharmacologic Actions Hypersensitivity Genetic Diseases, Inborn Sensory System Agents |
Analgesics, Non-Narcotic Therapeutic Uses Hypersensitivity, Immediate Skin Diseases, Eczematous Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Central Nervous System Agents Dermatologic Agents Skin Diseases, Genetic Dermatitis |