Epiceram Versus Elidel for Treatment of Mild to Moderate Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by:
Ceragenix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00460083
First received: April 11, 2007
Last updated: February 5, 2008
Last verified: February 2008
  Purpose

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.


Condition Intervention Phase
Atopic Dermatitis
Drug: Elidel(R) (pimecrolimus 1%)
Device: EpiCeram(R) -ceramide based barrier repair cream
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blinded Study of Epiceram Versus Elidel in Pediatric Subjects With Mild to Moderate Atopic Dermatitis

Resource links provided by NLM:


Further study details as provided by Ceragenix Pharmaceuticals:

Primary Outcome Measures:
  • The primary efficacy outcome is the change in mean Eczema Area and Severity Index (EASI) score in both groups. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent of subjects reaching clear or almost clear on Investigator's Global Assessment (IGA) at week 4. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change in mean capacitance in lesional and nonlesional skin at target site [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change in mean transepidermal water loss (TEWL) in lesional and nonlesional skin at target site [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change in pruritus score measured with a visual analog scale [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Comparison of baseline and Week 4 Children's Dermatitis Life Quality Index (CDLQI) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: April 2007
Study Completion Date: February 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Elidel(r) Drug: Elidel(R) (pimecrolimus 1%)
Experimental: Epiceram(r) Device: EpiCeram(R) -ceramide based barrier repair cream

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.

  Eligibility

Ages Eligible for Study:   2 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00460083

Locations
United States, California
UCSD
San Diego, California, United States
United States, Oregon
OHSU
Portland, Oregon, United States
Sponsors and Collaborators
Ceragenix Pharmaceuticals
Investigators
Principal Investigator: Eric Simpson, MD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Sr. Vice President, Research & Development, Ceragenix Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00460083     History of Changes
Other Study ID Numbers: CGXP - 060674/ IRB00002569
Study First Received: April 11, 2007
Last Updated: February 5, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Ceragenix Pharmaceuticals:
Atopic Dermatitis
eczema
dermatitis
skin barrier
barrier repair
ceramide
physiologic lipid
pruritus
Elidel
Epiceram
topical steroid

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Genetic Diseases, Inborn
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic
Decanoic acid
Pimecrolimus
Analgesics
Analgesics, Non-Narcotic
Anti-Infective Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antifungal Agents
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents
Immunologic Factors
Immunosuppressive Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014