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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 21, 2014