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Elidel-Study: Elidel in Patients With Atopic Dermatitis

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. Identifier: NCT00180141
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : May 9, 2008
Information provided by:
Technische Universität Dresden

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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Elidel-Creme Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
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
Study Start Date : April 2005
Actual Primary Completion Date : March 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00180141

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

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Responsible Party: Roland Aschoff, MD, Technical University Dresden Identifier: NCT00180141    
Other Study ID Numbers: CASM981CDE16
First Posted: September 16, 2005    Key Record Dates
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:
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Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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