Elidel-Study: Elidel in Patients With Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by:
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT00180141
First received: September 12, 2005
Last updated: May 6, 2008
Last verified: May 2008
  Purpose

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.


Condition Intervention Phase
Atopic Dermatitis
Drug: Elidel-Creme
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Control of Therapy With Elidel vs Placebo in Patients With Atopic Dermatitis Using Bioengineering Methods

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

Estimated Enrollment: 24
Study Start Date: April 2005
Study Completion Date: June 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT00180141

Locations
Germany
Technical University Dresden
Dresden, Sachsen, Germany, 01307
Sponsors and Collaborators
Technische Universität Dresden
Investigators
Principal Investigator: Roland Aschoff, MD Department of Dermatology. Medical Faculty, Technical University Dresden, Germany
  More Information

No publications provided

Responsible Party: Roland Aschoff, MD, Technical University Dresden
ClinicalTrials.gov Identifier: NCT00180141     History of Changes
Other Study ID Numbers: CASM981CDE16
Study First Received: September 12, 2005
Last Updated: May 6, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Technische Universität Dresden:
Atopic dermatitis on both lower arm.

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Genetic Diseases, Inborn
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic

ClinicalTrials.gov processed this record on October 23, 2014