Back to resultsEpiceram Versus Elidel for Treatment of Mild to Moderate Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Elidel(R) (pimecrolimus 1%)
EpiCeram(R) -ceramide based barrier repair cream
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic Dermatitis, eczema, dermatitis, skin barrier, barrier repair, ceramide, physiologic lipid, pruritus, Elidel, Epiceram, topical steroid
Eligibility Criteria
Inclusion Criteria:
- Males or females of any race 2 - 12 years of age.
- Diagnosis of atopic dermatitis on the basis of the criteria defined by Hanifin and Rajka (Hanifin, 1980).
- Rajka-Langeland Severity Index score of mild to moderate (Rajka, 1989).
- At least one antecubital or popliteal fossa must be affected at the time of enrollment to serve as a target site.
Exclusion Criteria:
- Subjects with severe AD as determined by the Rajka-Langeland Severity Index (Rajka 1989).
- Disease severity requiring medium-potency topical steroid medication to treat their atopic dermatitis more than 1 week per month.
- Subjects with unstable or uncontrolled medical conditions that could require intensive treatment during the course of the study.
- Subjects who require greater than 2.0 mg/day inhaled or intranasal corticosteroids.
- Subjects who are currently participating in or, within the past 28 days, have participated in another study using an investigational drug.
- Subjects with a history of allergy or hypersensitivity to Epiceram, Elidel, or ingredients therein, including fragrances.
- Active infection of any type at the start of the study.
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
- Subjects must have not used any topical or systemic therapy during the washout periods.
Sites / Locations
- UCSD
- OHSU
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Elidel(r)
Epiceram(r)
Arm Description
Outcomes
Primary Outcome Measures
The primary efficacy outcome is the change in mean Eczema Area and Severity Index (EASI) score in both groups.
Secondary Outcome Measures
Percent of subjects reaching clear or almost clear on Investigator's Global Assessment (IGA) at week 4.
Change in mean capacitance in lesional and nonlesional skin at target site
Change in mean transepidermal water loss (TEWL) in lesional and nonlesional skin at target site
Change in pruritus score measured with a visual analog scale
Comparison of baseline and Week 4 Children's Dermatitis Life Quality Index (CDLQI)
Full Information
NCT ID
NCT00460083
First Posted
April 11, 2007
Last Updated
February 5, 2008
Sponsor
Ceragenix Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00460083
Brief Title
Epiceram Versus Elidel for Treatment of Mild to Moderate Atopic Dermatitis
Official Title
A Randomized, Double-Blinded Study of Epiceram Versus Elidel in Pediatric Subjects With Mild to Moderate Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ceragenix Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Atopic Dermatitis, eczema, dermatitis, skin barrier, barrier repair, ceramide, physiologic lipid, pruritus, Elidel, Epiceram, topical steroid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Elidel(r)
Arm Type
Active Comparator
Arm Title
Epiceram(r)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Elidel(R) (pimecrolimus 1%)
Intervention Type
Device
Intervention Name(s)
EpiCeram(R) -ceramide based barrier repair cream
Primary Outcome Measure Information:
Title
The primary efficacy outcome is the change in mean Eczema Area and Severity Index (EASI) score in both groups.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Percent of subjects reaching clear or almost clear on Investigator's Global Assessment (IGA) at week 4.
Time Frame
4 weeks
Title
Change in mean capacitance in lesional and nonlesional skin at target site
Time Frame
4 weeks
Title
Change in mean transepidermal water loss (TEWL) in lesional and nonlesional skin at target site
Time Frame
4 weeks
Title
Change in pruritus score measured with a visual analog scale
Time Frame
4 weeks
Title
Comparison of baseline and Week 4 Children's Dermatitis Life Quality Index (CDLQI)
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males or females of any race 2 - 12 years of age.
Diagnosis of atopic dermatitis on the basis of the criteria defined by Hanifin and Rajka (Hanifin, 1980).
Rajka-Langeland Severity Index score of mild to moderate (Rajka, 1989).
At least one antecubital or popliteal fossa must be affected at the time of enrollment to serve as a target site.
Exclusion Criteria:
Subjects with severe AD as determined by the Rajka-Langeland Severity Index (Rajka 1989).
Disease severity requiring medium-potency topical steroid medication to treat their atopic dermatitis more than 1 week per month.
Subjects with unstable or uncontrolled medical conditions that could require intensive treatment during the course of the study.
Subjects who require greater than 2.0 mg/day inhaled or intranasal corticosteroids.
Subjects who are currently participating in or, within the past 28 days, have participated in another study using an investigational drug.
Subjects with a history of allergy or hypersensitivity to Epiceram, Elidel, or ingredients therein, including fragrances.
Active infection of any type at the start of the study.
Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
Subjects must have not used any topical or systemic therapy during the washout periods.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Simpson, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD
City
San Diego
State/Province
California
Country
United States
Facility Name
OHSU
City
Portland
State/Province
Oregon
Country
United States
12. IPD Sharing Statement
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Epiceram Versus Elidel for Treatment of Mild to Moderate Atopic Dermatitis
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