Study About Effectiveness of Silver-Containing Textiles f... | NCT00196430

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

NCT00196430

Sponsor

University Medicine Greifswald

Status

Completed

Last Update Posted

Sep 20, 2005Estimated

Enrollment

Phase

Phase 3

Conditions

Neurodermatitis

Interventions

silver-contained textiles
corticosteroid

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2004

Primary Completion Date

Not provided

Completion Date

Aug 2004

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 20, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2005

Last Update Posted Date

Sep 20, 2005Estimated

Name	Class
Julius Zorn GmbH, Aichach, Germany	UNKNOWN

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SCORAD at days -3,0,7,14,28,56 for every group

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Jünger, Prof. Dr.	Clinic and Polyclinic of Dermatology, University of Greifswald	Principal Investigator
Andrea Ladwig	Clinic and Polyclinic of Dermatology, University of Greifswald	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinic and Polyclinic of Dermatology, Ernst-Moritz-Arndt-University of Greifswald		Greifswald	Fleischmannstr. 42-44	17475	Germany

Condition Browse Module

MeSH Terms

ID	Term
D009450	Neurodermatitis

Ancestor Terms

ID	Term
D003872	Dermatitis
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D017443	Skin Diseases, Eczematous

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000305	Adrenal Cortex Hormones

Ancestor Terms

ID	Term
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
silver-contained textiles	Device
corticosteroid	Drug