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

NCT00616538 | Completed Phase 4

• 1 other identifier: CPI 2006-002
• Study Type: interventional
• Target: 121
• Locations: 0 countries
• Sites: N/A

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

Keywords

Atopic; Dermatitis; eczema; skin barrier; ceramide; topical; inflamation; steroid; SCORAD; glucocorticoids; EpiCeram; Cutivate; fluticasone

Outcome Measures

Primary Outcomes (1)

• Change in the mean Severity Scoring for Atopic Dermatitis (SCORAD)

  4 weeks

Secondary Outcomes (2)

• 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

Study Arms (2)

Cutivate(r)

ACTIVE COMPARATOR

Topical mid-strength steroid

Drug: Fluticasone Propionate 0.05%

EpiCeram(r)

EXPERIMENTAL

EpiCeram(r) topical barrier repair cream.

Device: Epiceram(r)

Interventions

Epiceram(r) DEVICE

Topical barrier repair emulsion cream

EpiCeram(r)

Fluticasone Propionate 0.05% DRUG

Topical mid-strength steroid

Cutivate(r)

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ceragenix Pharmaceuticals: lead

MeSH Terms

Conditions

Dermatitis, Atopic; Dermatitis; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Jeffrey Sugarman, MD

  University of California, San Francisco, CA

  PRINCIPAL INVESTIGATOR

• Lawrence Parrish, MD

  Medical College of Thomas Jefferson University, Philadelphia, PA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 5, 2008
• First Posted: February 15, 2008
• Study Start: December 1, 2006
• Primary Completion: April 1, 2007
• Last Updated: February 15, 2008

Record last verified: 2008-02