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

Neurodermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00196430
• Other study ID #: III PV 08/03
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: September 12, 2005
• Start date: January 2004
• Est. completion date: August 2004

Study information

• Verified date: September 2005
• Source: University Medicine Greifswald
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neurodermatitis

Intervention

Device:
• silver-contained textiles

Drug:
• corticosteroid

Locations

Country	Name	City	State
Germany	Clinic and Polyclinic of Dermatology, Ernst-Moritz-Arndt-University of Greifswald	Greifswald	Fleischmannstr. 42-44

Sponsors (2)

Lead Sponsor	Collaborator
University Medicine Greifswald	Julius Zorn GmbH, Aichach, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SCORAD at days -3,0,7,14,28,56 for every group
Secondary	Influence of silver containing textiles in reducing bacterial skin colonization (especially Staph. aureus)
Secondary	Consumption of corticosteroids at days 0-28
Secondary	Consumption of corticosteroids at days 28-56
Secondary	Pruritus under textiles
Secondary	Evaluation of quality of life