Epiceram™ Device Versus Mid-Strength Topical Steroid (Fluticasone Propionate 0.05%) for Treatment of Atopic Dermatitis
This study has been completed.
Sponsor:
Ceragenix Pharmaceuticals
Information provided by:
Ceragenix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00616538
First received: February 5, 2008
Last updated: NA
Last verified: February 2008
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Atopic Dermatitis |
Device: Epiceram(r) Drug: Fluticasone Propionate 0.05% |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Ceragenix Pharmaceuticals:
Primary Outcome Measures:
- Change in the mean Severity Scoring for Atopic Dermatitis (SCORAD) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Percentage of subjects reaching clear or almost clear on Investigator's Global Assessment (IGA) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Change in assessments of Pruritus and sleep habits [ Time Frame: week 4 ] [ Designated as safety issue: No ]
| Enrollment: | 121 |
| Study Start Date: | December 2006 |
| Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Cutivate(r)
Topical mid-strength steroid
|
Drug: Fluticasone Propionate 0.05%
Topical mid-strength steroid
|
|
Experimental: EpiCeram(r)
EpiCeram(r) topical barrier repair cream.
|
Device: Epiceram(r)
Topical barrier repair emulsion cream
|
Eligibility| Ages Eligible for Study: | 6 Months to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00616538
Sponsors and Collaborators
Ceragenix Pharmaceuticals
Investigators
| Principal Investigator: | Jeffrey Sugarman, MD | University of California, San Francisco, CA |
| Principal Investigator: | Lawrence Parrish, MD | Medical College of Thomas Jefferson University, Philadelphia, PA |
More Information
No publications provided
| Responsible Party: | Sr. Vice President, Research & Development, Ceragenix Pharmaceuticals Inc. |
| ClinicalTrials.gov Identifier: | NCT00616538 History of Changes |
| Other Study ID Numbers: | CPI 2006-002 |
| Study First Received: | February 5, 2008 |
| Last Updated: | February 5, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Ceragenix Pharmaceuticals:
|
Atopic Dermatitis eczema skin barrier ceramide topical inflamation |
steroid SCORAD glucocorticoids EpiCeram Cutivate fluticasone |
Additional relevant MeSH terms:
|
Dermatitis Dermatitis, Atopic Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Decanoic acid Fluticasone Antifungal Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Dermatologic Agents Anti-Allergic Agents Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 16, 2013