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

September 12, 2005 updated by: University Medicine Greifswald

Prospective, Controlled Three-Armed Study About Effectiveness and Compatibility of Silver-Containing Textiles for Treatment of Acute Neurodermatitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

32

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medicine Greifswald

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Study Completion

August 1, 2004

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

September 20, 2005

Last Update Submitted That Met QC Criteria

September 12, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • III PV 08/03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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