Status:
COMPLETED
A Pre-market Study to Evaluate the Performance and Safety of a Skin Preparation Device for Removal of Dry Crusty Skin
Lead Sponsor:
Mirka Ltd
Collaborating Sponsors:
Clinius Ltd
Conditions:
Keratosis, Actinic
Actinic Lesion
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- Attending the clinic for treatment of actinic keratosis using daylight photodynamic therapy
- 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
- Known or suspected allergy/hypersensitivity to phenol formaldehyde
- 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.
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 26 2023
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT05356572
Start Date
September 1 2022
End Date
September 26 2023
Last Update
October 10 2023
Active Locations (1)
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1
Vaasa Central Hospital
Vaasa, Finland, 65130