A Pre-market Study to Evaluate the Performance and Safety of a Skin Preparation Device for Removal of Dry Crusty Skin
NCT ID: NCT05356572
Last Updated: 2023-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
26 participants
INTERVENTIONAL
2022-09-01
2023-09-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Investigational Skin Preparation Device versus Disposable Dermal Curette
Investigational Skin Preparation Device
Removal of hyperkeratotic skin with Investigational Skin Preparation Device
UMDNS 13-230 / Biopsy punch (Dermal Curette)
Removal of hyperkeratotic skin with Disposable Dermal Curette
Investigational Skin Preparation Device versus Abrasive Pad for Skin Preparation
Investigational Skin Preparation Device
Removal of hyperkeratotic skin with Investigational Skin Preparation Device
GMDN 47102 / Electrode Skin Abrasive Pad
Removal of hyperkeratotic skin with Abrasive Pad for Skin Preparation
Interventions
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Investigational Skin Preparation Device
Removal of hyperkeratotic skin with Investigational Skin Preparation Device
GMDN 47102 / Electrode Skin Abrasive Pad
Removal of hyperkeratotic skin with Abrasive Pad for Skin Preparation
UMDNS 13-230 / Biopsy punch (Dermal Curette)
Removal of hyperkeratotic skin with Disposable Dermal Curette
Eligibility Criteria
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Inclusion Criteria
* Age: 18 - 100 years.
* Available for two follow-up visits: two weeks after treatment and 4 months after treatment
* Provision of informed consent i.e., subject must be able to understand and sign the patient Information and Consent Form
* Subject have been informed on the nature, the scope and the relevance of the study
Exclusion Criteria
* Wound at the skin site to be treated
* Documented skin disease at the time of enrollment, as judged by the investigator
* Previously enrolled in the present investigation
* Inclusion in other ongoing investigations simultaneously that would preclude the subject from participating in this investigation as judged by the investigator
* Actinic keratosis treatment obtained within last 6 months
* Involvement in the planning and conduct of the clinical investigation (applies to all investigation site staff and third party vendor)
* Any subject that according to Medical Research Act, paragraphs 7-10, is deemed unsuitable for study enrolment.
* Complications that would increase wound risks if investigational product would be used.
18 Years
100 Years
ALL
Yes
Sponsors
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Clinius Ltd
INDUSTRY
Mirka Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Johanna H Hagman, M.D, PhD
Role: PRINCIPAL_INVESTIGATOR
Vaasa Central Hospital, Vaasa, Finland
Locations
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Vaasa Central Hospital
Vaasa, , Finland
Countries
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Other Identifiers
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AMCIREP2204
Identifier Type: -
Identifier Source: org_study_id
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