NeurodermatitisPhase 3NCT00196430
Study About Effectiveness of Silver-Containing Textiles for Treatment of Acute Neurodermatitis
A Phase 3 study testing silver-contained textiles and corticosteroid in people with Neurodermatitis, run by University Medicine Greifswald at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 70 years
- Conditions the study is for
- Neurodermatitis
- What is being tested?
- silver-contained textiles and corticosteroid
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2004to Aug 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of acute Neurodermitis
- Age: 2-70 years
- Patients are mobile
- Patient's information and willingness to participate
Who cannot join
- 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)
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- Severe general diseases (e.g. melanoma, renal insufficiency, autoimmune diseases)
- Pregnancy
- Fertile females without effective contraception
Trial locations and contacts
1 site in 1 country.
Germany1 site
Clinic and Polyclinic of Dermatology, Ernst-Moritz-Arndt-University of Greifswald
Greifswald, Fleischmannstr. 42-44, 17475
About this study
Official title: Prospective, Controlled Three-Armed Study About Effectiveness and Compatibility of Silver-Containing Textiles for Treatment of Acute Neurodermatitis
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.
- Conditions
- Neurodermatitis
- Being tested
- silver-contained textiles, corticosteroid
- Medical subject headings
- Neurodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
silver-contained textilesDevice
corticosteroidDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJan 2004
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeurodermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Enrolment
- 32 participants
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Collaborators
- Julius Zorn GmbH, Aichach, Germany
- Investigators
- Michael Jünger, Prof. Dr., Principal investigator, Clinic and Polyclinic of Dermatology, University of GreifswaldAndrea Ladwig, Study chair, Clinic and Polyclinic of Dermatology, University of Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00196430
- Sponsor's protocol ID
- III PV 08/03
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 20 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Controlled Three-Armed Study About Effectiveness and Compatibility of Silver-Containing Textiles for Treatment of Acute Neurodermatitis
- ClinicalTrials.gov ID
- NCT00196430
- Acronym / sponsor ID
- III PV 08/03
- Conditions
- Neurodermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Collaborators
- Julius Zorn GmbH, Aichach, Germany
- Study start
- Jan 2004
- Study completion
- Aug 2004
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 2 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of acute Neurodermitis
- Age: 2-70 years
- Patients are mobile
- Patient's information and willingness to participate
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| silver-contained textiles | Device | – |
| corticosteroid | Drug | – |
Primary outcome
SCORAD at days -3,0,7,14,28,56 for every group
5 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Jünger, Prof. Dr. principal investigator
Clinic and Polyclinic of Dermatology, University of Greifswald
Andrea Ladwig study chair
Clinic and Polyclinic of Dermatology, University of Greifswald
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing silver-contained textiles and corticosteroid in people with Neurodermatitis, run by University Medicine Greifswald at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SCORAD at days -3,0,7,14,28,56 for every group. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2005.