A Pre-market Study to Evaluate the Performance and Safety of a Skin Preparation Device for Remova… (NCT05356572) | Clinical Trial Compass
CompletedNot Applicable
A Pre-market Study to Evaluate the Performance and Safety of a Skin Preparation Device for Removal of Dry Crusty Skin
Finland26 participantsStarted 2022-09-01
Plain-language 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.
Who can participate
Age range18 Years – 100 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.