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Epiceram Versus Elidel for Treatment of Mild to Moderate Atopic Dermatitis

NCT00460083 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2008-02-06

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Elidel(R) (pimecrolimus 1%)

DEVICE

EpiCeram(R) -ceramide based barrier repair cream

Sponsors & Collaborators

  • Ceragenix Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Eric Simpson, MD · Oregon Health and Science University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2007-12-31
Completion
2008-02-29

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00460083 on ClinicalTrials.gov