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

Study Overview
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Brief Summary
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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.

Official Title
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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

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

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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |