A Pre-market Study to Evaluate the Performance and Safety of a Skin Preparation Device for Removal of Dry Crusty Skin

Mirka Ltd

Status: Completed

Conditions: Hyperkeratosis; Keratosis, Actinic; Solar Keratosis/Sunburn; Hyperkeratotic; Lesion; Actinic Lesion; Hyperkeratotic Callus; Hyperkeratotic Actinic Keratosis

Treatments: Device: UMDNS 13-230 / Biopsy punch (Dermal Curette); Device: GMDN 47102 / Electrode Skin Abrasive Pad; Device: Investigational Skin Preparation Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT05356572

AMCIREP2204

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Investigational Skin Preparation Device versus Disposable Dermal Curette

Active Comparator group

Treatment:

Device: UMDNS 13-230 / Biopsy punch (Dermal Curette)

Device: Investigational Skin Preparation Device

Investigational Skin Preparation Device versus Abrasive Pad for Skin Preparation

Active Comparator group

Treatment:

Device: GMDN 47102 / Electrode Skin Abrasive Pad

Device: Investigational Skin Preparation Device