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NCT00180141 Clinical Trial

Elidel-Study: Elidel in Patients With Atopic Dermatitis

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00180141
Other study ID # CASM981CDE16
Secondary ID
Status Completed
Phase Phase 4
First received September 12, 2005
Last updated May 6, 2008
Start date April 2005
Est. completion date June 2007

Study information
Verified date May 2008
Source Technische Universität Dresden
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date June 2007
Est. primary completion date March 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Elidel-Creme

Locations
Country Name City State
Germany Technical University Dresden Dresden Sachsen

Sponsors (1)
Lead Sponsor Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

See also
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