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 range
18 Years – 100 Years
Sex
ALL
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.