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

Primary Purpose

Keratosis, Actinic, Actinic Lesion, Solar Keratosis/Sunburn

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Investigational Skin Preparation Device
GMDN 47102 / Electrode Skin Abrasive Pad
UMDNS 13-230 / Biopsy punch (Dermal Curette)
Sponsored by
Mirka Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratosis, Actinic

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Vaasa Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Investigational Skin Preparation Device versus Disposable Dermal Curette

Investigational Skin Preparation Device versus Abrasive Pad for Skin Preparation

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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)
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)

Full Information

First Posted
April 14, 2022
Last Updated
October 6, 2023
Sponsor
Mirka Ltd
Collaborators
Clinius Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05356572
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
September 26, 2023 (Actual)
Study Completion Date
September 26, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mirka Ltd
Collaborators
Clinius Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratosis, Actinic, Actinic Lesion, Solar Keratosis/Sunburn, Hyperkeratosis, Hyperkeratotic Callus, Hyperkeratotic; Lesion, Hyperkeratotic Actinic Keratosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Investigational Skin Preparation Device versus Disposable Dermal Curette
Arm Type
Active Comparator
Arm Title
Investigational Skin Preparation Device versus Abrasive Pad for Skin Preparation
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Investigational Skin Preparation Device
Intervention Description
Removal of hyperkeratotic skin with Investigational Skin Preparation Device
Intervention Type
Device
Intervention Name(s)
GMDN 47102 / Electrode Skin Abrasive Pad
Intervention Description
Removal of hyperkeratotic skin with Abrasive Pad for Skin Preparation
Intervention Type
Device
Intervention Name(s)
UMDNS 13-230 / Biopsy punch (Dermal Curette)
Intervention Description
Removal of hyperkeratotic skin with Disposable Dermal Curette
Primary Outcome Measure Information:
Title
Grade of hyperkeratotic skin removal
Description
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.
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Grade of injury to skin / grade of skin irritation / grade of allergic skin reaction
Description
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.
Time Frame
Day 0
Title
Grade of skin irritation / grade of allergic skin reaction
Description
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.
Time Frame
14 day follow-up
Title
Duration of operation time per treated skin area
Description
Operation time assessed by the mean difference in time per treated skin area to remove the hyperkeratotic skin in comparison to comparative methods.
Time Frame
Day 0
Title
Presence of actinic keratosis
Description
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.
Time Frame
Day 0
Title
Clearance of actinic keratosis
Description
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.
Time Frame
4th month follow-up
Title
Physician comfort during skin preparation using an investigator questionnaire
Description
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.
Time Frame
Day 0
Title
Subject comfort during skin preparation using a subject questionnaire
Description
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.
Time Frame
Day 0
Title
Subject pain sensation during skin preparation
Description
Rate of pain using visual analogue scale (VAS). VAS: 0 - 10 (0= No pain and 10 = worst possible pain)
Time Frame
Day 0
Title
Subject pain sensation during daylight photodynamic treatment
Description
Rate of pain using visual analogue scale (VAS). VAS: 0 - 10 (0= No pain and 10 = worst possible pain)
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johanna H Hagman, M.D, PhD
Organizational Affiliation
Vaasa Central Hospital, Vaasa, Finland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vaasa Central Hospital
City
Vaasa
ZIP/Postal Code
65130
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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