Back to resultsElidel-Study: Elidel in Patients With Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Elidel-Creme
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic dermatitis on both lower arm.
Eligibility Criteria
Inclusion Criteria: Age > 18 years Atopic dermatitis on both lower arms at least 1% body surface area. Atopic Dermatitis Severity Index (ADSI)-Score >= 6 Investigator Global Assessment (IGA)-Score >= 2 Exclusion Criteria: Systemic therapy with immunosuppressive drugs within the past 24 weeks Phototherapy against atopic dermatitis. Antibiotic therapy against atopic dermatitis. Allergy against Elidel. Pregnancy Nursing Skin cancer
Sites / Locations
- Technical University Dresden
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00180141
First Posted
September 12, 2005
Last Updated
May 6, 2008
Sponsor
Technische Universität Dresden
1. Study Identification
Unique Protocol Identification Number
NCT00180141
Brief Title
Elidel-Study: Elidel in Patients With Atopic Dermatitis
Official Title
Control of Therapy With Elidel vs Placebo in Patients With Atopic Dermatitis Using Bioengineering Methods
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Technische Universität Dresden
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Atopic dermatitis is a common disease. Emollients and Elidel have both shown to be effective to treat this disease. The research question is, whether the effective component (Elidel) is better than the emollient to improve the skin function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Atopic dermatitis on both lower arm.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Elidel-Creme
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 18 years
Atopic dermatitis on both lower arms at least 1% body surface area.
Atopic Dermatitis Severity Index (ADSI)-Score >= 6
Investigator Global Assessment (IGA)-Score >= 2
Exclusion Criteria:
Systemic therapy with immunosuppressive drugs within the past 24 weeks
Phototherapy against atopic dermatitis.
Antibiotic therapy against atopic dermatitis.
Allergy against Elidel.
Pregnancy
Nursing
Skin cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roland Aschoff, MD
Organizational Affiliation
Department of Dermatology. Medical Faculty, Technical University Dresden, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Technical University Dresden
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Elidel-Study: Elidel in Patients With Atopic Dermatitis
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