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

Primary Purpose

Neurodermatitis

Status

Completed

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

silver-contained textiles

corticosteroid

About this trial

This is an interventional treatment trial for Neurodermatitis

Eligibility Criteria

2 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Outcomes

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

Full Information

NCT ID

NCT00196430

First Posted

September 12, 2005

Last Updated

September 12, 2005

Sponsor

University Medicine Greifswald

Collaborators

Julius Zorn GmbH, Aichach, Germany

1. Study Identification

Unique Protocol Identification Number

NCT00196430

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Completed

Study Start Date

January 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

August 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University Medicine Greifswald

Collaborators

Julius Zorn GmbH, Aichach, Germany

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neurodermatitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

Single

Allocation

Randomized

Enrollment

32 (false)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

silver-contained textiles

Intervention Type

Drug

Intervention Name(s)

corticosteroid

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

Title

Consumption of corticosteroids at days 0-28

Title

Consumption of corticosteroids at days 28-56

Title

Pruritus under textiles

Title

Evaluation of quality of life

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Jünger, Prof. Dr.

Organizational Affiliation

Clinic and Polyclinic of Dermatology, University of Greifswald

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Andrea Ladwig

Organizational Affiliation

Clinic and Polyclinic of Dermatology, University of Greifswald

Official's Role

Study Chair

Facility Information:

Facility Name

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

City

Greifswald

State/Province

Fleischmannstr. 42-44

ZIP/Postal Code

17475

Country

Germany

12. IPD Sharing Statement

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

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