Elidel-Study: Elidel in Patients With Atopic Dermatitis - Full Text View

Elidel-Study: Elidel in Patients With Atopic Dermatitis

This study has been completed.

Sponsored by:	Dresden University of Technology
Information provided by:	Dresden University of Technology
ClinicalTrials.gov Identifier:	NCT00180141

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 IV

Drug Information available for:

Pimecrolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Official Title:	Control of Therapy With Elidel vs Placebo in Patients With Atopic Dermatitis Using Bioengineering Methods

Further study details as provided by Dresden University of Technology:

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00180141

Locations


Germany, Sachsen
	Technical University Dresden
	Dresden, Sachsen, Germany, 01307

Sponsors and Collaborators

Dresden University of Technology

Investigators


Principal Investigator:	Roland Aschoff, MD	Department of Dermatology. Medical Faculty, Technical University Dresden, Germany

More Information

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

Keywords provided by Dresden University of Technology:

Atopic dermatitis on both lower arm.

Study placed in the following topic categories:

Hypersensitivity

Dermatitis, Atopic

Genetic Diseases, Inborn

Skin Diseases

Hypersensitivity, Immediate

Skin Diseases, Eczematous

Pimecrolimus

Skin Diseases, Genetic

Dermatitis

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Immunologic Factors

Immune System Diseases

Physiological Effects of Drugs

Immunosuppressive Agents

Pharmacologic Actions

Analgesics, Non-Narcotic

Sensory System Agents

Therapeutic Uses

Anti-Inflammatory Agents, Non-Steroidal

Analgesics

Peripheral Nervous System Agents

Antirheumatic Agents

Central Nervous System Agents

Dermatologic Agents

ClinicalTrials.gov processed this record on October 27, 2008