Study About Effectiveness of Silver-Containing Textiles for Treatment of Acute Neurodermatitis
This study has been completed.
Sponsor:
University Medicine Greifswald
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 16, 2012
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 16, 2012