Clinical trial NCT05356572: A Pre-market Study to Evaluate the Performance and Safety of a Skin Preparation Device for Removal of Dry Crusty Skin
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Keratosis, Actinic
Actinic Lesion
Solar Keratosis/Sunburn
Hyperkeratosis
Hyperkeratotic Callus
Hyperkeratotic; Lesion
Hyperkeratotic Actinic Keratosis
Lead sponsor: Mirka Ltd
Sponsor class: INDUSTRY
Collaborators: name: Clinius Ltd
First posted: 2022-05-02
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 during skin preparation, as well as performance and safety of device, will be compared to comparators on separate skin areas for every subject.


Eligibility criteria: 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.

Primary outcomes:
measure: Grade of hyperkeratotic skin removal
timeFrame: Day 0
Secondary outcomes:
measure: Grade of injury to skin / grade of skin irritation / grade of allergic skin reaction
timeFrame: Day 0
measure: Grade of skin irritation / grade of allergic skin reaction
timeFrame: 14 day follow-up
measure: Duration of operation time per treated skin area
timeFrame: Day 0
measure: Presence of actinic keratosis
timeFrame: Day 0
measure: Clearance of actinic keratosis
timeFrame: 4th month follow-up
measure: Physician comfort during skin preparation using an investigator questionnaire
timeFrame: Day 0
measure: Subject comfort during skin preparation using a subject questionnaire
timeFrame: Day 0
measure: Subject pain sensation during skin preparation
timeFrame: Day 0
measure: Subject pain sensation during daylight photodynamic treatment
timeFrame: Day 0
Other outcomes:
Locations:
city: Vaasa
country: Finland
facility: Vaasa Central Hospital
Study officials:
affiliation: Vaasa Central Hospital, Vaasa, Finland
name: Johanna H Hagman, M.D, PhD
role: PRINCIPAL_INVESTIGATOR
References: