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

February 5, 2008 updated by: Ceragenix Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in the mean Severity Scoring for Atopic Dermatitis (SCORAD)
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

February 5, 2008

First Submitted That Met QC Criteria

February 5, 2008

First Posted (Estimate)

February 15, 2008

Study Record Updates

Last Update Posted (Estimate)

February 15, 2008

Last Update Submitted That Met QC Criteria

February 5, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPI 2006-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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