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

This study has been completed.
Sponsor:
Information provided by:
Ceragenix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00616538
First received: February 5, 2008
Last updated: NA
Last verified: February 2008
History: No changes posted
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


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
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

  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

No publications provided

Responsible Party: Sr. Vice President, Research & Development, Ceragenix Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00616538     History of Changes
Other Study ID Numbers: CPI 2006-002
Study First Received: February 5, 2008
Last Updated: February 5, 2008
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

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Decanoic acid
Fluticasone
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 17, 2014