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Completed

NCT Number: NCT00196430

Study About Effectiveness 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.

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Key information

Conditions

Neurodermatitis Dermatitis Skin Diseases Skin Diseases, Eczematous Skin and Connective Tissue Diseases

Age range

2 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinic and Polyclinic of Dermatology, Ernst-Moritz-Arndt-University of Greifswald

Greifswald, Fleischmannstr. 42-44, 17475, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

silver-contained textiles

Device

Corticosteroid

Drug

Primary outcomes

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

Secondary outcomes

  1. Influence of silver containing textiles in reducing bacterial skin colonization (especially Staph. aureus)

  2. Consumption of corticosteroids at days 0-28

  3. Consumption of corticosteroids at days 28-56

  4. Pruritus under textiles

  5. Evaluation of quality of life

Sponsors and collaborators

Lead sponsor

University Medicine Greifswald

Other

Collaborators

  • Julius Zorn GmbH, Aichach, Germany

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2004
First posted
Sep 20, 2005
Registry last updated
Sep 20, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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