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

This study has been completed.
Sponsor:
Collaborator:
Julius Zorn GmbH, Aichach, Germany
Information provided by:
University Medicine Greifswald
ClinicalTrials.gov Identifier:
NCT00196430
First received: September 12, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Prospective, Controlled Three-Armed Study About Effectiveness and Compatibility of Silver-Containing Textiles for Treatment of Acute Neurodermatitis

Resource links provided by NLM:

MedlinePlus related topics: Steroids
U.S. FDA Resources

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

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
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

No publications provided

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

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

ClinicalTrials.gov processed this record on May 16, 2013