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Sponsored by: |
Ceragenix Pharmaceuticals |
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Information provided by: | Ceragenix Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00616538 |
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
Condition | Intervention | Phase |
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Atopic Dermatitis |
Device: Epiceram(r) Drug: Fluticasone Propionate 0.05% |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment |
Official Title: | 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 |
Enrollment: | 121 |
Study Start Date: | December 2006 |
Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Cutivate(r): Active Comparator
Topical mid-strength steroid
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Drug: Fluticasone Propionate 0.05%
Topical mid-strength steroid
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EpiCeram(r): Experimental
EpiCeram(r) topical barrier repair cream.
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Device: Epiceram(r)
Topical barrier repair emulsion cream
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Ages Eligible for Study: | 6 Months to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Jeffrey Sugarman, MD | University of California, San Francisco, CA |
Principal Investigator: | Lawrence Parrish, MD | Medical College of Thomas Jefferson University, Philadelphia, PA |
Responsible Party: | Ceragenix Pharmaceuticals Inc. ( Sr. Vice President, Research & Development ) |
Study ID Numbers: | CPI 2006-002 |
Study First Received: | February 5, 2008 |
Last Updated: | February 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00616538 History of Changes |
Health Authority: | United States: Institutional Review Board |
Atopic Dermatitis eczema skin barrier ceramide topical inflamation |
steroid SCORAD glucocorticoids EpiCeram Cutivate fluticasone |
Anti-Inflammatory Agents Dermatitis, Atopic Skin Diseases Anti-Asthmatic Agents Anti-Allergic Agents Eczema Glucocorticoids Hypersensitivity |
Genetic Diseases, Inborn Hypersensitivity, Immediate Skin Diseases, Eczematous Fluticasone Peripheral Nervous System Agents Skin Diseases, Genetic Bronchodilator Agents Dermatitis |
Anti-Inflammatory Agents Respiratory System Agents Dermatitis, Atopic Skin Diseases Immune System Diseases Physiological Effects of Drugs Anti-Asthmatic Agents Anti-Allergic Agents Pharmacologic Actions Hypersensitivity Genetic Diseases, Inborn |
Autonomic Agents Therapeutic Uses Hypersensitivity, Immediate Skin Diseases, Eczematous Fluticasone Peripheral Nervous System Agents Dermatologic Agents Skin Diseases, Genetic Bronchodilator Agents Dermatitis |