Epiceram Versus Elidel for Treatment of Mild to Moderate Atopic Dermatitis

February 5, 2008 updated by: Ceragenix Pharmaceuticals

A Randomized, Double-Blinded Study of Epiceram Versus Elidel in Pediatric Subjects With Mild to Moderate Atopic Dermatitis

Atopic dermatitis (AD) is a common skin disease that has increased in prevalence worldwide two- to threefold over the last 50 years. Epiceram, a newly FDA-approved medical device is a topical barrier repair cream designed to deliver special epidermal lipids to the top layers of the skin in order to correct skin barrier abnormalities found in atopic dermatitis. Epiceram does not contain corticosteroids or other conventional anti-inflammatory components and represents a novel class of skin barrier repair therapy for inflammatory skin disease.

The objective of this study is to determine whether Epiceram is a safe and effective therapy for mild to moderate atopic dermatitis and whether it may serve as an alternative to Elidel therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Atopic dermatitis (AD) is a common skin disease that has increased in prevalence worldwide two- to threefold over the last 50 years. Current standard of care for atopic dermatitis includes topical corticosteroids and calcineurin inhibitors, such as Elidel and Protopic. The chronic use of topical corticosteroids is limited by side effects including skin atrophy, striae, and even HPA axis suppression. The long-term effects of skin immunosuppression with calcineurin inhibitors are unknown and although not proven, a theoretical risk of skin cancer exists. Novel therapies for atopic dermatitis that avoid immunosupression are greatly needed.

Epiceram, a newly FDA-approved medical device is a topical barrier repair cream designed to deliver special epidermal lipids to the top layers of the skin in order to correct skin barrier abnormalities found in atopic dermatitis. Epiceram does not contain corticosteroids or other conventional anti-inflammatory components and represents a novel class of skin barrier repair therapy for inflammatory skin disease. The objective of this study is to determine whether Epiceram is a safe and effective therapy for mild to moderate atopic dermatitis and whether it may serve as an alternative to Elidel therapy.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States
        • UCSD
    • Oregon
      • Portland, Oregon, United States
        • OHSU

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

1 year to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Males or females of any race 2 - 12 years of age.
  2. Diagnosis of atopic dermatitis on the basis of the criteria defined by Hanifin and Rajka (Hanifin, 1980).
  3. Rajka-Langeland Severity Index score of mild to moderate (Rajka, 1989).
  4. At least one antecubital or popliteal fossa must be affected at the time of enrollment to serve as a target site.

Exclusion Criteria:

  1. Subjects with severe AD as determined by the Rajka-Langeland Severity Index (Rajka 1989).
  2. Disease severity requiring medium-potency topical steroid medication to treat their atopic dermatitis more than 1 week per month.
  3. Subjects with unstable or uncontrolled medical conditions that could require intensive treatment during the course of the study.
  4. Subjects who require greater than 2.0 mg/day inhaled or intranasal corticosteroids.
  5. Subjects who are currently participating in or, within the past 28 days, have participated in another study using an investigational drug.
  6. Subjects with a history of allergy or hypersensitivity to Epiceram, Elidel, or ingredients therein, including fragrances.
  7. Active infection of any type at the start of the study.
  8. Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
  9. Subjects must have not used any topical or systemic therapy during the washout periods.

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: Elidel(r)
Drug: Elidel(R) (pimecrolimus 1%)
Experimental: Epiceram(r)
Device: EpiCeram(R) -ceramide based barrier repair cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary efficacy outcome is the change in mean Eczema Area and Severity Index (EASI) score in both groups.
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent of subjects reaching clear or almost clear on Investigator's Global Assessment (IGA) at week 4.
Time Frame: 4 weeks
4 weeks
Change in mean capacitance in lesional and nonlesional skin at target site
Time Frame: 4 weeks
4 weeks
Change in mean transepidermal water loss (TEWL) in lesional and nonlesional skin at target site
Time Frame: 4 weeks
4 weeks
Change in pruritus score measured with a visual analog scale
Time Frame: 4 weeks
4 weeks
Comparison of baseline and Week 4 Children's Dermatitis Life Quality Index (CDLQI)
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

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

Sponsor

Ceragenix Pharmaceuticals

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

April 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

April 11, 2007

First Submitted That Met QC Criteria

April 11, 2007

First Posted (Estimate)

April 13, 2007

Study Record Updates

Last Update Posted (Estimate)

February 6, 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

  • CGXP - 060674/ IRB00002569

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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