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

Not Applicable

Completed

• Conditions: Hyperkeratotic Callus; Solar Keratosis/Sunburn; Hyperkeratotic Actinic Keratosis; Keratosis, Actinic; Actinic Lesion; Hyperkeratosis; Hyperkeratotic; Lesion
• Interventions: Device: Investigational Skin Preparation Device; Device: UMDNS 13-230 / Biopsy punch (Dermal Curette); Device: GMDN 47102 / Electrode Skin Abrasive Pad

• Registration Number: NCT05356572
• Lead Sponsor: Mirka Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-14
• Study First Submitted QC: 2022-04-26
• Study First Posted: 2022-05-02
• Study Start: 2022-09-01
• Primary Completion: 2023-09-26
• Study Completion: 2023-09-26
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-06
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Investigational Skin Preparation Device versus Disposable Dermal Curette	UMDNS 13-230 / Biopsy punch (Dermal Curette)	-
Investigational Skin Preparation Device versus Disposable Dermal Curette	Investigational Skin Preparation Device	-
Investigational Skin Preparation Device versus Abrasive Pad for Skin Preparation	Investigational Skin Preparation Device	-
Investigational Skin Preparation Device versus Abrasive Pad for Skin Preparation	GMDN 47102 / Electrode Skin Abrasive Pad	-

Primary Outcome Measures

Name	Time	Method
Grade of hyperkeratotic skin removal	Day 0	Sufficient hyperkeratotic skin removal in comparison to comparative methods. The removal of hyperkeratotic skin is assessed visually and by palpation.; Removal of hyperkeratotic skin measurement grades: All hyperkeratotic skin removed, Partial hyperkeratotic skin removed, None hyperkeratotic skin removed.

Secondary Outcome Measures

Name	Time	Method
Subject comfort during skin preparation using a subject questionnaire	Day 0	Rate of subject comfort (including skin sensation and heating of skin) when comparing the investigational product with comparative methods. The endpoint will utilize a questionnaire for the subject to fill in.; Skin sensation during skin preparation: Very pleasant, Pleasant, Neutral, Unpleasant, Very unpleasant.; Heating of skin during skin preparation: None, Mild temperature rise, Moderate temperature rise, High temperature rise, Burning.
Subject pain sensation during daylight photodynamic treatment	Day 0	Rate of pain using visual analogue scale (VAS). VAS: 0 - 10 (0= No pain and 10 = worst possible pain)
Grade of skin irritation / grade of allergic skin reaction	14 day follow-up	Investigator assessment of adverse effects on skin in comparison to the comparative methods.; Grade of skin irritation: none, mild, moderate, severe. Grade of allergic skin reaction: none, mild, moderate, severe.
Grade of injury to skin / grade of skin irritation / grade of allergic skin reaction	Day 0	Investigator assessment of adverse effects on skin in comparison to the comparative methods.; Grade of injury to skin: none, mild, moderate, severe. Grade of skin irritation: none, mild, moderate, severe. Grade of allergic skin reaction: none, mild, moderate, severe.
Duration of operation time per treated skin area	Day 0	Operation time assessed by the mean difference in time per treated skin area to remove the hyperkeratotic skin in comparison to comparative methods.
Clearance of actinic keratosis	4th month follow-up	Number of different grades of actinic keratosis (AK) lesions are measured: None, Grade I AK lesions, Grade II AK lesions, Grade III AK lesions.; Actinic keratosis clearance is assessed as the number of cleared actinic keratosis lesions at 4th month follow-up divided by the actinic keratosis lesion number at Day 0. Clearance will be reported in %. A high %-value means a high number of cleared lesions.
Subject pain sensation during skin preparation	Day 0	Rate of pain using visual analogue scale (VAS). VAS: 0 - 10 (0= No pain and 10 = worst possible pain)
Physician comfort during skin preparation using an investigator questionnaire	Day 0	Rate of physician comfort when comparing the investigational product versus comparative methods. The endpoint will utilize a questionnaire for the investigator/nurse to fill in.
Presence of actinic keratosis	Day 0	Presence of actinic keratosis (AK) is measured by number of different grades of AK lesions.; Number of different grades of AK lesions: None, Grade I AK lesions, Grade II AK lesions, Grade III AK lesions.

Trial Locations

Locations (1)

Vaasa Central Hospital; 🇫🇮 Vaasa, Finland