Trials / Completed
CompletedNCT05356572
A Pre-market Study to Evaluate the Performance and Safety of a Skin Preparation Device for Removal of Dry Crusty Skin
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- Mirka Ltd · Industry
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
- Keratosis, Actinic
- Actinic Lesion
- Solar Keratosis/Sunburn
- Hyperkeratosis
- Hyperkeratotic Callus
- Hyperkeratotic; Lesion
- Hyperkeratotic Actinic Keratosis
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Investigational Skin Preparation Device | Removal of hyperkeratotic skin with Investigational Skin Preparation Device |
| DEVICE | GMDN 47102 / Electrode Skin Abrasive Pad | Removal of hyperkeratotic skin with Abrasive Pad for Skin Preparation |
| DEVICE | UMDNS 13-230 / Biopsy punch (Dermal Curette) | Removal of hyperkeratotic skin with Disposable Dermal Curette |
Timeline
- Start date
- 2022-09-01
- Primary completion
- 2023-09-26
- Completion
- 2023-09-26
- First posted
- 2022-05-02
- Last updated
- 2023-10-10
Locations
1 site across 1 country: Finland
Source: ClinicalTrials.gov record NCT05356572. Inclusion in this directory is not an endorsement.