An interventional study of Investigational Skin Preparation Device and GMDN 47102 / Electrode Skin Abrasive Pad in Keratosis, Actinic, Actinic Lesion and Solar Keratosis/Sunburn, sponsored by Mirka Ltd. Completed at 1 site in Finland. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-10.
Sponsored by Mirka Ltd · Not applicable, Interventional, and Treatment
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.
343 studies on the registry are indexed under Keratosis, Actinic; 29 are open to participants now.
This study's enrollment of 26 is below the median of 60 across 295 interventional studies indexed under Keratosis, Actinic.
Browse Keratosis, Actinic studies →This is the only study on the registry with Mirka Ltd as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Investigational Skin Preparation Device · Device: UMDNS 13-230 / Biopsy punch (Dermal Curette)
Device: Investigational Skin Preparation Device · Device: GMDN 47102 / Electrode Skin Abrasive Pad
Removal of hyperkeratotic skin with Investigational Skin Preparation Device
Removal of hyperkeratotic skin with Abrasive Pad for Skin Preparation
Removal of hyperkeratotic skin with Disposable Dermal Curette
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.
Time frame: Day 0
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: Day 0
Plan to share: No
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This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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