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

Phase 4

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: Fluticasone Propionate 0.05%; Device: Epiceram(r)

• Registration Number: NCT00616538
• Lead Sponsor: Ceragenix Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Primary Completion: 2007-04
• Status Verified: 2008-02
• Study First Submitted: 2008-02-05
• Study First Submitted QC: 2008-02-05
• Last Update Submitted: 2008-02-05
• Study First Posted: 2008-02-15
• Last Update Posted: 2008-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cutivate(r)	Fluticasone Propionate 0.05%	Topical mid-strength steroid
EpiCeram(r)	Epiceram(r)	EpiCeram(r) topical barrier repair cream.

Primary Outcome Measures

Name	Time	Method
Change in the mean Severity Scoring for Atopic Dermatitis (SCORAD)	4 weeks

Secondary Outcome Measures

Name	Time	Method
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