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

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. Identifier: NCT00616538
Recruitment Status : Completed
First Posted : February 15, 2008
Last Update Posted : February 15, 2008
Information provided by:
Ceragenix Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Device: Epiceram(r) Drug: Fluticasone Propionate 0.05% Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
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
Study Start Date : December 2006
Actual Primary Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change in the mean Severity Scoring for Atopic Dermatitis (SCORAD) [ Time Frame: 4 weeks ]

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

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.

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Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT00616538

Sponsors and Collaborators
Ceragenix Pharmaceuticals
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Principal Investigator: Jeffrey Sugarman, MD University of California, San Francisco, CA
Principal Investigator: Lawrence Parrish, MD Medical College of Thomas Jefferson University, Philadelphia, PA

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Responsible Party: Sr. Vice President, Research & Development, Ceragenix Pharmaceuticals Inc. Identifier: NCT00616538    
Other Study ID Numbers: CPI 2006-002
First Posted: February 15, 2008    Key Record Dates
Last Update Posted: February 15, 2008
Last Verified: February 2008
Keywords provided by Ceragenix Pharmaceuticals:
skin barrier
Additional relevant MeSH terms:
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Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases
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