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

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Johanna H Hagman, M.D, PhD; Phone Number: +358 6 213 2682; Email: johanna.hagman@ovph.fi

Study Locations

• Finland
  • Vaasa, Finland, 65130
    • Vaasa Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Investigational Skin Preparation Device versus Disposable Dermal Curette	Device: Investigational Skin Preparation Device; Removal of hyperkeratotic skin with Investigational Skin Preparation Device; Device: UMDNS 13-230 / Biopsy punch (Dermal Curette); Removal of hyperkeratotic skin with Disposable Dermal Curette
Active Comparator: Investigational Skin Preparation Device versus Abrasive Pad for Skin Preparation	Device: Investigational Skin Preparation Device; Removal of hyperkeratotic skin with Investigational Skin Preparation Device; Device: GMDN 47102 / Electrode Skin Abrasive Pad; Removal of hyperkeratotic skin with Abrasive Pad for Skin Preparation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grade of hyperkeratotic skin removal	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.	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grade of injury to skin / grade of skin irritation / grade of allergic skin reaction	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.	Day 0
Grade of skin irritation / grade of allergic skin reaction	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.	14 day follow-up
Duration of operation time per treated skin area	Operation time assessed by the mean difference in time per treated skin area to remove the hyperkeratotic skin in comparison to comparative methods.	Day 0
Presence of actinic keratosis	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.	Day 0
Clearance of actinic keratosis	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.	4th month follow-up
Physician comfort during skin preparation using an investigator questionnaire	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.	Day 0
Subject comfort during skin preparation using a subject questionnaire	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.	Day 0
Subject pain sensation during skin preparation	Rate of pain using visual analogue scale (VAS). VAS: 0 - 10 (0= No pain and 10 = worst possible pain)	Day 0
Subject pain sensation during daylight photodynamic treatment	Rate of pain using visual analogue scale (VAS). VAS: 0 - 10 (0= No pain and 10 = worst possible pain)	Day 0

Collaborators and Investigators

• Sponsor: Mirka Ltd
• Collaborators: Clinius Ltd
• Investigators: Principal Investigator: Johanna H Hagman, M.D, PhD, Vaasa Central Hospital, Vaasa, Finland

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): September 26, 2023
• Study Completion (Actual): September 26, 2023

Study Registration Dates

• First Submitted: April 14, 2022
• First Submitted That Met QC Criteria: April 26, 2022
• First Posted (Actual): May 2, 2022

Study Record Updates

• Last Update Posted (Estimated): October 9, 2023
• Last Update Submitted That Met QC Criteria: October 6, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Wounds and Injuries; Precancerous Conditions; Burns; Photosensitivity Disorders; Keratosis, Actinic; Keratosis; Sunburn
• Other Study ID Numbers: AMCIREP2204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No