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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00196430
First Posted: September 20, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Julius Zorn GmbH, Aichach, Germany
Information provided by:
University Medicine Greifswald
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment
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 University Medicine 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

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00196430


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

ClinicalTrials.gov Identifier: NCT00196430     History of Changes
Other Study ID Numbers: III PV 08/03
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2005

Additional relevant MeSH terms:
Neurodermatitis
Dermatitis
Skin Diseases
Skin Diseases, Eczematous