NCT00196430

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2004

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

September 20, 2005

Status Verified

September 1, 2005

First QC Date

September 12, 2005

Last Update Submit

September 12, 2005

Conditions

Neurodermatitis

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

  • 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

Interventions

silver-contained textilesDEVICE
corticosteroidDRUG

Eligibility Criteria

Age2 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of acute Neurodermitis
  • Age: 2-70 years
  • Patients are mobile
  • Patient's information and willingness to participate

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Greifswald, Fleischmannstr. 42-44, 17475, Germany

Location

MeSH Terms

Conditions

Neurodermatitis

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Eczematous

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

January 1, 2004

Study Completion

August 1, 2004

Last Updated

September 20, 2005

Record last verified: 2005-09

Locations

DE(1)