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

Mirka Ltd26 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes