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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05356572
Other study ID # AMCIREP2204
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
See also
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Completed NCT01458587 - Levulan PDT Versus Vehicle for Extremity Actinic Keratoses (AK) Phase 2
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Recruiting NCT06135415 - A Study to Evaluate the Efficacy and Safety of Tirbanibulin Ointment in Adult Participants With Actinic Keratosis Phase 3
Completed NCT02644187 - Pain Relief During Photodynamic Therapy for Actinic Keratoses With a New Irradiation Protocol N/A
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Completed NCT05060237 - Study to Evaluate Safety and Tolerability of BF-200 ALA (Ameluz®) for Photodynamic Therapy in the Treatment of the Expanded Field of Actinic Keratosis on Face and Scalp Phase 1
Terminated NCT04269395 - A Study to Assess Recurrence of Actinic Keratosis in Participants Treated With Methyl Aminolevulinate Hydrochloride Cream or Vehicle Cream Who Achieved Complete Response to Treated Lesions in Earlier Study Phase 3