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

Sponsored by:	Ceragenix Pharmaceuticals
Information provided by:	Ceragenix Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00616538

Purpose

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	Intervention	Phase
Atopic Dermatitis	Device: Epiceram(r) Drug: Fluticasone Propionate 0.05%	Phase IV

Drug Information available for: Fluticasone Fluticasone propionate Ceramide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment
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

Further study details as provided by Ceragenix Pharmaceuticals:

Primary Outcome Measures:

Change in the mean Severity Scoring for Atopic Dermatitis (SCORAD) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Enrollment:	121
Study Start Date:	December 2006
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Cutivate(r): Active Comparator Topical mid-strength steroid	Drug: Fluticasone Propionate 0.05% Topical mid-strength steroid
EpiCeram(r): Experimental EpiCeram(r) topical barrier repair cream.	Device: Epiceram(r) Topical barrier repair emulsion cream

Eligibility

Ages Eligible for Study:	6 Months to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00616538

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

More Information

Responsible Party:	Ceragenix Pharmaceuticals Inc. ( Sr. Vice President, Research & Development )
Study ID Numbers:	CPI 2006-002
Study First Received:	February 5, 2008
Last Updated:	February 5, 2008
ClinicalTrials.gov Identifier:	NCT00616538
Health Authority:	United States: Institutional Review Board

Keywords provided by Ceragenix Pharmaceuticals:

Atopic
Dermatitis
eczema
skin barrier
ceramide
topical
inflamation

steroid
SCORAD
glucocorticoids
EpiCeram
Cutivate
fluticasone

Study placed in the following topic categories:

Hypersensitivity
Dermatitis, Atopic
Genetic Diseases, Inborn
Skin Diseases
Hypersensitivity, Immediate

Fluticasone
Skin Diseases, Eczematous
Eczema
Skin Diseases, Genetic
Dermatitis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Immune System Diseases
Autonomic Agents
Therapeutic Uses
Physiological Effects of Drugs

Anti-Asthmatic Agents
Anti-Allergic Agents
Peripheral Nervous System Agents
Dermatologic Agents
Bronchodilator Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009