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Elidel-Study: Elidel in Patients With Atopic Dermatitis

NCT ID: NCT00180141

Last Updated: 2008-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2007-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Atopic Dermatitis

Keywords

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Atopic dermatitis on both lower arm.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Elidel-Creme

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technische Universität Dresden

OTHER

Sponsor Role lead

Responsible Party

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Technical University Dresden

Principal Investigators

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Roland Aschoff, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology. Medical Faculty, Technical University Dresden, Germany

Locations

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Technical University Dresden

Dresden, Saxony, Germany

Site Status

Countries

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Germany

Other Identifiers

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CASM981CDE16

Identifier Type: -

Identifier Source: org_study_id