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Completed

NCT Number: NCT05356572

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

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Key information

Conditions

Keratosis, Actinic Actinic Lesion Burns Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hyperkeratosis Hyperkeratotic Actinic Keratosis Hyperkeratotic Callus Hyperkeratotic; Lesion Keratoderma, Palmoplantar Keratoderma, Palmoplantar, Diffuse Keratoderma, Palmoplantar, Epidermolytic Keratosis Neoplasms Photosensitivity Disorders Precancerous Conditions Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases Solar Keratosis/Sunburn Sunburn Wounds and Injuries

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vaasa Central Hospital

Vaasa, 65130, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Investigational Skin Preparation Device

Device

Removal of hyperkeratotic skin with Investigational Skin Preparation Device

GMDN 47102 / Electrode Skin Abrasive Pad

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Grade of injury to skin / grade of skin irritation / grade of allergic skin reaction

    Time frame: Day 0

    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.

  2. Grade of skin irritation / grade of allergic skin reaction

    Time frame: 14 day follow-up

    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.

  3. Duration of operation time per treated skin area

    Time frame: Day 0

    Operation time assessed by the mean difference in time per treated skin area to remove the hyperkeratotic skin in comparison to comparative methods.

  4. Presence of actinic keratosis

    Time frame: Day 0

    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.

  5. Clearance of actinic keratosis

    Time frame: 4th month follow-up

    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.

  6. Physician comfort during skin preparation using an investigator questionnaire

    Time frame: Day 0

    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.

  7. Subject comfort during skin preparation using a subject questionnaire

    Time frame: Day 0

    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.

  8. Subject pain sensation during skin preparation

    Time frame: Day 0

    Rate of pain using visual analogue scale (VAS). VAS: 0 - 10 (0= No pain and 10 = worst possible pain)

  9. Subject pain sensation during daylight photodynamic treatment

    Time frame: Day 0

    Rate of pain using visual analogue scale (VAS). VAS: 0 - 10 (0= No pain and 10 = worst possible pain)

Sponsors and collaborators

Lead sponsor

Mirka Ltd

Industry

Collaborators

  • Clinius Ltd

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 2, 2022
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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