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

NCT ID: NCT00616538

Last Updated: 2008-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cutivate(r)

Topical mid-strength steroid

Group Type: ACTIVE_COMPARATOR

Fluticasone Propionate 0.05%

Intervention Type: DRUG

Topical mid-strength steroid

EpiCeram(r)

EpiCeram(r) topical barrier repair cream.

Group Type: EXPERIMENTAL

Epiceram(r)

Intervention Type: DEVICE

Topical barrier repair emulsion cream

Interventions

Epiceram(r)

Topical barrier repair emulsion cream

Intervention Type: DEVICE

Fluticasone Propionate 0.05%

Topical mid-strength steroid

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ceragenix Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Ceragenix Pharmaceuticals Inc.

Principal Investigators

Jeffrey Sugarman, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco, CA

Lawrence Parrish, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Thomas Jefferson University, Philadelphia, PA

Other Identifiers

CPI 2006-002

Identifier Type: -

Identifier Source: org_study_id