Study About Effectiveness of Silver-Containing Textiles for Treatment of Acute Neurodermatitis

This study has been completed.

Sponsors and Collaborators:	Ernst Moritz Arndt University of Greifswald Julius Zorn GmbH, Aichach, Germany
Information provided by:	Ernst Moritz Arndt University of Greifswald
ClinicalTrials.gov Identifier:	NCT00196430

Purpose

The purpose of this study is to investigate whether the treatment of acute neurodermitis with silver-contained textiles is equivalent or more effective to the conservative exogenous treatment with a corticosteroid. Secondary aim is to define skin comfortability of the textiles.

Condition	Intervention	Phase
Neurodermatitis	Device: silver-contained textiles Drug: corticosteroid	Phase III

Drug Information available for: Corticosteroids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Prospective, Controlled Three-Armed Study About Effectiveness and Compatibility of Silver-Containing Textiles for Treatment of Acute Neurodermatitis

Further study details as provided by Ernst Moritz Arndt University of Greifswald:

Primary Outcome Measures:

SCORAD at days -3,0,7,14,28,56 for every group

Secondary Outcome Measures:

Influence of silver containing textiles in reducing bacterial skin colonization (especially Staph. aureus)
Consumption of corticosteroids at days 0-28
Consumption of corticosteroids at days 28-56
Pruritus under textiles
Evaluation of quality of life

Estimated Enrollment:	32
Study Start Date:	January 2004
Estimated Study Completion Date:	August 2004

Eligibility

Ages Eligible for Study:	2 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of acute Neurodermitis
Age: 2-70 years
Patients are mobile
Patient's information and willingness to participate

Exclusion Criteria:

Acute viral infection (herpes zoster, eczema herpeticum)
Acute staphylodermas
Other skin-diseases affecting outcomes of intervention (e.g. psoriasis)
Current UV-Treatment
Current other immunosuppressive or immunomodulated Therapy
Current antimicrobial Therapy (e.g. antibiotics)
Severe general diseases (e.g. melanoma, renal insufficiency, autoimmune diseases)
Pregnancy
Fertile females without effective contraception

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00196430

Locations

Germany, Fleischmannstr. 42-44
Clinic and Polyclinic of Dermatology, Ernst-Moritz-Arndt-University of Greifswald
Greifswald, Fleischmannstr. 42-44, Germany, 17475

Sponsors and Collaborators

Ernst Moritz Arndt University of Greifswald

Julius Zorn GmbH, Aichach, Germany

Investigators

Principal Investigator:	Michael Jünger, Prof. Dr.	Clinic and Polyclinic of Dermatology, University of Greifswald
Study Chair:	Andrea Ladwig	Clinic and Polyclinic of Dermatology, University of Greifswald

More Information

Study ID Numbers:	III PV 08/03
Study First Received:	September 12, 2005
Last Updated:	September 12, 2005
ClinicalTrials.gov Identifier:	NCT00196430
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Skin Diseases
Skin Diseases, Eczematous
Neurodermatitis
Dermatitis

ClinicalTrials.gov processed this record on January 16, 2009