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Elidel-Study: Elidel in Patients With Atopic Dermatitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00180141
First Posted: September 16, 2005
Last Update Posted: May 9, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Technische Universität Dresden
  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
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Roland Aschoff, MD, Technical University Dresden
ClinicalTrials.gov Identifier: NCT00180141     History of Changes
Other Study ID Numbers: CASM981CDE16
First Submitted: September 12, 2005
First Posted: September 16, 2005
Last Update Posted: May 9, 2008
Last Verified: May 2008

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

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pimecrolimus
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action