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

Keratosis, Actinic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05356572
• Other study ID #: AMCIREP2204
• Status: Completed
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: September 26, 2023

Study information

• Verified date: October 2023
• Source: Mirka Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 26, 2023
• Est. primary completion date: September 26, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperkeratosis
• Hyperkeratotic Callus
• Keratosis
• Keratosis, Actinic
• Sunburn

Intervention

Device:
• Investigational Skin Preparation Device
Removal of hyperkeratotic skin with Investigational Skin Preparation Device
• GMDN 47102 / Electrode Skin Abrasive Pad
Removal of hyperkeratotic skin with Abrasive Pad for Skin Preparation
• UMDNS 13-230 / Biopsy punch (Dermal Curette)
Removal of hyperkeratotic skin with Disposable Dermal Curette

Locations

Country	Name	City	State
Finland	Vaasa Central Hospital	Vaasa

Sponsors (2)

Lead Sponsor	Collaborator
Mirka Ltd	Clinius Ltd

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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