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...
Date First Received: September 12, 2005
Last Updated: May 6, 2008
Verified by: Dresden University of Technology, May 2008
Clinical Trial Phase: Phase 4 | Start Date: April 2005
Overall Status: Completed
Estimated Enrollment: 24
Brief Summary
Official Title: “Control of Therapy With Elidel vs Placebo in Patients With Atopic Dermatitis Using Bioengineering Methods”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Study Primary Completion Date: March 2007
Intervention(s) in this Clinical Trial
- Drug: Elidel-Creme
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Dresden University of Technology
Overall Clinical Trial Officials and Contacts
Roland Aschoff, MD Principal Investigator Department of Dermatology. Medical Faculty, Technical University Dresden, Germany
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00180141
Study ID Number: CASM981CDE16
ClinicalTrials.gov Identifier: NCT00180141
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Clinical Trials Authorship and Review
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