| February 5, 2008 |
| February 5, 2008 |
| December 2006 |
| April 2007 (final data collection date for primary outcome measure) |
| Change in the mean Severity Scoring for Atopic Dermatitis (SCORAD) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ] |
| Same as current |
| No Changes Posted |
- 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 ]
|
| Same as current |
| |
| 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. |
| |
| Phase IV |
| Interventional |
| Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment |
| Atopic Dermatitis |
- Device: Epiceram(r)
- Drug: Fluticasone Propionate 0.05%
|
- Active Comparator: Topical mid-strength steroid
- Experimental: EpiCeram(r) topical barrier repair cream.
|
| |
| |
| Completed |
| 121 |
|
| April 2007 (final data collection date for primary outcome measure) |
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.
|
| Both |
| 6 Months to 18 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
|
| |
| NCT00616538 |
| Sr. Vice President, Research & Development, Ceragenix Pharmaceuticals Inc. |
| CPI 2006-002 |
| Ceragenix Pharmaceuticals |
|
| Principal Investigator: |
Jeffrey Sugarman, MD |
University of California, San Francisco, CA |
|
| Principal Investigator: |
Lawrence Parrish, MD |
Medical College of Thomas Jefferson University, Philadelphia, PA |
|
|
| Ceragenix Pharmaceuticals |
| February 2008 |
