A Single-center, Open, Randomized, Non-controlled, Comparative Pre-market Investigation to Evaluate the Performance of a Skin Preparation Device for Removal of Hyperkeratotic Skin
Sponsor study identifier
interventional
26
1 country
1
Study Start
September 1, 2022
Actual (reported)Primary Completion
September 26, 2023
Actual (reported)Study Completion
September 26, 2023
Actual (reported)In this clinical one-site investigation the performance and safety of a skin preparation device will be evaluated for removing hyperkeratotic skin prior to further medical treatment. Comfort and pain during skin preparation, as well as performance and safety of device, will be compared to comparators on separate skin areas for every subject.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 26, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 14, 2022
Actual (reported)May 2, 2022
Actual (reported)September 1, 2022
Actual (reported)September 26, 2023
Actual (reported)September 26, 2023
Actual (reported)Grade of hyperkeratotic skin removal
Sufficient hyperkeratotic skin removal in comparison to comparative methods. The removal of hyperkeratotic skin is assessed visually and by palpation. Removal of hyperkeratotic skin measurement grades: All hyperkeratotic skin removed, Partial hyperkeratotic skin removed, None hyperkeratotic skin removed.
Day 0
Grade of injury to skin / grade of skin irritation / grade of allergic skin reaction
Day 0
Grade of skin irritation / grade of allergic skin reaction
14 day follow-up
Removal of hyperkeratotic skin with Investigational Skin Preparation Device
Removal of hyperkeratotic skin with Abrasive Pad for Skin Preparation
Vaasa Central Hospital
Vaasa, 65130, Finland
Johanna H Hagman, M.D, PhD
Vaasa Central Hospital, Vaasa, Finland
26 participants (actual enrollment reported by the registry).
First Submitted
April 14, 2022
First Posted
May 2, 2022
Study Start
September 1, 2022
Actual (reported)Patient Decision Aid for the Treatment of Actinic Keratosis
Duration of operation time per treated skin area
Day 0
Presence of actinic keratosis
Day 0
Clearance of actinic keratosis
4th month follow-up
Removal of hyperkeratotic skin with Disposable Dermal Curette
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
September 26, 2023
Actual (reported)Study Completion
September 26, 2023
Actual (reported)Last Updated
October 10, 2023
Record last verified: 2023-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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