Epiceram Versus Elidel for Treatment of Mild to Moderate Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00460083
• Other study ID #: CGXP - 060674/ IRB00002569
• Status: Completed
• Phase: Phase 4
• First received: April 11, 2007
• Last updated: February 5, 2008
• Start date: April 2007
• Est. completion date: February 2008

Study information

• Verified date: February 2008
• Source: Ceragenix Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: February 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 12 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Elidel(R) (pimecrolimus 1%)

Device:
• EpiCeram(R) -ceramide based barrier repair cream

Locations

Country	Name	City	State
United States	OHSU	Portland	Oregon
United States	UCSD	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Ceragenix Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy outcome is the change in mean Eczema Area and Severity Index (EASI) score in both groups.		4 weeks	No
Secondary	Percent of subjects reaching clear or almost clear on Investigator's Global Assessment (IGA) at week 4.		4 weeks	No
Secondary	Change in mean capacitance in lesional and nonlesional skin at target site		4 weeks	No
Secondary	Change in mean transepidermal water loss (TEWL) in lesional and nonlesional skin at target site		4 weeks	No
Secondary	Change in pruritus score measured with a visual analog scale		4 weeks	No
Secondary	Comparison of baseline and Week 4 Children's Dermatitis Life Quality Index (CDLQI)		4 weeks	No