NCT00196430
Completed
Phase 3
Prospective, Controlled Three-Armed Study About Effectiveness and Compatibility of Silver-Containing Textiles for Treatment of Acute Neurodermatitis
University Medicine Greifswald1 site in 1 country32 target enrollmentStarted: January 2004Last updated:
ConditionsNeurodermatitis
Drugscorticosteroid
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- University Medicine Greifswald
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- SCORAD at days -3,0,7,14,28,56 for every group
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single
Eligibility Criteria
- Ages
- 2 Years to 70 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
SCORAD at days -3,0,7,14,28,56 for every group
Secondary Outcomes
- 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
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Unknown
Phase 4
A Prospective Randomised Controlled Trial of Management of Recurrent Nosebleeds in ChildrenEpistaxisNCT00390663NHS Greater Glasgow Yorkhill Division216
Completed
Phase 3
The Use of Silver Leaf Dressing in the Prevention of Radiotherapy Induced Skin ReactionsBreast NeoplasmsNCT00207324British Columbia Cancer Agency100
Completed
Not Applicable
Efficacy of the Use of Silver Diamine Fluoride and Sodium Fluoride Varnish for the Treatment of Caries in ChildrenDental Caries in ChildrenNCT05638217Universidad Mayor de San Simón199
Completed
Not Applicable
Long-term Follow-up Study of Subjects Who Completed Clinical Studies 755.1100_FA, 810.1100_FA, or 1064.1100_FAAcne VulgarisNCT03039634Sienna Labs76
Completed
Not Applicable
Clinical Evaluation of Silver Nanoparticles in Comparison to Silver Diamine Fluoride in Management of Deep Carious LesionsCaries,DentalNCT05231330Suez Canal University36