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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00616538
First Posted: February 15, 2008
Last Update Posted: February 15, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ceragenix Pharmaceuticals
  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 (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 ]

Secondary Outcome Measures:
  • Percentage of subjects reaching clear or almost clear on Investigator's Global Assessment (IGA) [ Time Frame: 4 weeks ]
  • Change in assessments of Pruritus and sleep habits [ Time Frame: week 4 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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: Sr. Vice President, Research & Development, Ceragenix Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00616538     History of Changes
Other Study ID Numbers: CPI 2006-002
First Submitted: February 5, 2008
First Posted: February 15, 2008
Last Update Posted: February 15, 2008
Last Verified: February 2008

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
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Decanoic acid
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Antifungal Agents
Anti-Infective Agents