Keratosis, ActinicNCT05356572
A Pre-market Study to Evaluate the Performance and Safety of a Skin Preparation Device for Removal of Dry Crusty Skin
A study testing Investigational Skin Preparation Device, GMDN 47102 / Electrode Skin Abrasive Pad and UMDNS 13-230 / Biopsy punch (Dermal Curette) in people with Keratosis, Actinic and Actinic Lesion, run by Mirka Ltd at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Keratosis, Actinic, Actinic Lesion, Solar Keratosis/Sunburn
- What is being tested?
- Investigational Skin Preparation Device, GMDN 47102 / Electrode Skin Abrasive Pad and UMDNS 13-230 / Biopsy punch (Dermal Curette)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteFinland
- Study dates
- 1 Sep 2022to 26 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Keratosis, Actinic, Actinic Lesion, Solar Keratosis/Sunburn, Hyperkeratosis, Hyperkeratotic Callus, Hyperkeratotic; Lesion
- Being tested
- Investigational Skin Preparation Device, GMDN 47102 / Electrode Skin Abrasive Pad, UMDNS 13-230 / Biopsy punch (Dermal Curette)
- Medical subject headings
- Keratosis, Actinic, Sunburn, Keratoderma, Palmoplantar, Epidermolytic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Skin Preparation DeviceDevice
Removal of hyperkeratotic skin with Investigational Skin Preparation Device
GMDN 47102 / Electrode Skin Abrasive PadDevice
Removal of hyperkeratotic skin with Abrasive Pad for Skin Preparation
UMDNS 13-230 / Biopsy punch (Dermal Curette)Device
Removal of hyperkeratotic skin with Disposable Dermal Curette
| Study group | Role | What they receive |
|---|---|---|
| Investigational Skin Preparation Device versus Disposable Dermal Curette | Active comparator | Not described Receives: Device: Investigational Skin Preparation Device; Device: UMDNS 13-230 / Biopsy punch (Dermal Curette) |
| Investigational Skin Preparation Device versus Abrasive Pad for Skin Preparation | Active comparator | Not described Receives: Device: Investigational Skin Preparation Device; Device: GMDN 47102 / Electrode Skin Abrasive Pad |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start1 Sep 2022
- Primary completion26 Sep 2023
- Study completion26 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keratosis, ActinicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mirka Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinius Ltd
- Responsible party
- Sponsor
- Investigators
- Johanna H Hagman, M.D, PhD, Principal investigator, Vaasa Central Hospital, Vaasa, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05356572
- Sponsor's protocol ID
- AMCIREP2204
- Status last verified
- Oct 2023
- First submitted
- 14 Apr 2022
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05356572
- Acronym / sponsor ID
- AMCIREP2204
- Conditions
- Keratosis, Actinic, Actinic Lesion, Solar Keratosis/Sunburn, Hyperkeratosis, Hyperkeratotic Callus, Hyperkeratotic; Lesion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Mirka LtdIndustry (pharma, biotech, devices)
- Collaborators
- Clinius Ltd
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 26 Sep 2023 (actual)
- Study completion
- 26 Sep 2023 (actual)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational Skin Preparation Device versus Disposable Dermal Curette | Active comparator | Device: Investigational Skin Preparation Device, Device: UMDNS 13-230 / Biopsy punch (Dermal Curette) |
| Investigational Skin Preparation Device versus Abrasive Pad for Skin Preparation | Active comparator | Device: Investigational Skin Preparation Device, Device: GMDN 47102 / Electrode Skin Abrasive Pad |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational Skin Preparation DeviceRemoval of hyperkeratotic skin with Investigational Skin Preparation Device | Device | Investigational Skin Preparation Device versus Abrasive Pad for Skin Preparation, Investigational Skin Preparation Device versus Disposable Dermal Curette |
| GMDN 47102 / Electrode Skin Abrasive PadRemoval of hyperkeratotic skin with Abrasive Pad for Skin Preparation | Device | Investigational Skin Preparation Device versus Abrasive Pad for Skin Preparation |
| UMDNS 13-230 / Biopsy punch (Dermal Curette)Removal of hyperkeratotic skin with Disposable Dermal Curette | Device | Investigational Skin Preparation Device versus Disposable Dermal Curette |
Primary outcome
Grade of hyperkeratotic skin removal
Time frame: Day 0
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.
9 secondary outcomes
Grade of injury to skin / grade of skin irritation / grade of allergic skin reaction
Time frame: Day 0
Grade of skin irritation / grade of allergic skin reaction
Time frame: 14 day follow-up
Duration of operation time per treated skin area
Time frame: Day 0
Presence of actinic keratosis
Time frame: Day 0
Clearance of actinic keratosis
Time frame: 4th month follow-up
Physician comfort during skin preparation using an investigator questionnaire
Time frame: Day 0
Subject comfort during skin preparation using a subject questionnaire
Time frame: Day 0
Subject pain sensation during skin preparation
Time frame: Day 0
Subject pain sensation during daylight photodynamic treatment
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Keratosis, Actinic
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
RecruitingPhase 3
Using an Artificial Intelligence (AI) Tool for Melanoma Diagnosis
Malignant Melanoma of Skin, Other and Unspecified Malignant Neoplasm of Skin
RecruitingPhase 3
Basal Cell Carcinoma Chemoprevention Trial
Basal Cell Carcinoma
Active, not recruitingPhase 4
Cryotherapy in Combination With Red Light PDT for Actinic Keratosis of Full Face
Actinic Keratoses
Not yet recruiting
Therapeutic Induction of Dermal Remodeling in Veterans to Prevent Actinic Neoplasia Caused by Chronic Environmental Exposure to Ultraviolet Radiation
Nonmelanoma Skin Cancer, Actinic Keratosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johanna H Hagman, M.D, PhD principal investigator
Vaasa Central Hospital, Vaasa, Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational Skin Preparation Device, GMDN 47102 / Electrode Skin Abrasive Pad and UMDNS 13-230 / Biopsy punch (Dermal Curette) in people with Keratosis, Actinic and Actinic Lesion, run by Mirka Ltd at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade of hyperkeratotic skin removal (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.