Epiceram™ Device Versus Mid-Strength Topical Steroid (Fluticasone Propionate 0.05%) for Treatment of Atopic Dermatitis

Sponsor

Ceragenix Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00616538

Collaborator

(none)

121

Enrollment

Arms

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Atopic Dermatitis	Device: Epiceram(r) Drug: Fluticasone Propionate 0.05%	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

121 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (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

Study Start Date :

Dec 1, 2006

Actual Primary Completion Date :

Apr 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Change in the mean Severity Scoring for Atopic Dermatitis (SCORAD) [4 weeks]

Secondary Outcome Measures

Percentage of subjects reaching clear or almost clear on Investigator's Global Assessment (IGA) [4 weeks]
Change in assessments of Pruritus and sleep habits [week 4]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

No locations specified.

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