NCT05356572

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 2, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2023

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

1.1 years

First QC Date

April 14, 2022

Last Update Submit

October 6, 2023

Conditions

Keratosis, ActinicActinic LesionSolar Keratosis/SunburnHyperkeratosisHyperkeratotic CallusHyperkeratotic; LesionHyperkeratotic Actinic Keratosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Grade of injury to skin / grade of skin irritation / grade of allergic skin reaction

    Day 0

  • Grade of skin irritation / grade of allergic skin reaction

    14 day follow-up

  • Duration of operation time per treated skin area

    Day 0

  • Presence of actinic keratosis

    Day 0

  • Clearance of actinic keratosis

    4th month follow-up

  • +4 more secondary outcomes

Study Arms (2)

Investigational Skin Preparation Device versus Disposable Dermal Curette

ACTIVE COMPARATOR
Device: Investigational Skin Preparation DeviceDevice: UMDNS 13-230 / Biopsy punch (Dermal Curette)

Investigational Skin Preparation Device versus Abrasive Pad for Skin Preparation

ACTIVE COMPARATOR
Device: Investigational Skin Preparation DeviceDevice: GMDN 47102 / Electrode Skin Abrasive Pad

Interventions

Investigational Skin Preparation DeviceDEVICE

Removal of hyperkeratotic skin with Investigational Skin Preparation Device

Investigational Skin Preparation Device versus Abrasive Pad for Skin PreparationInvestigational Skin Preparation Device versus Disposable Dermal Curette
GMDN 47102 / Electrode Skin Abrasive PadDEVICE

Removal of hyperkeratotic skin with Abrasive Pad for Skin Preparation

Investigational Skin Preparation Device versus Abrasive Pad for Skin Preparation
UMDNS 13-230 / Biopsy punch (Dermal Curette)DEVICE

Removal of hyperkeratotic skin with Disposable Dermal Curette

Investigational Skin Preparation Device versus Disposable Dermal Curette

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vaasa Central Hospital

Vaasa, 65130, Finland

Location

MeSH Terms

Conditions

Keratosis, ActinicSunburnKeratoderma, Palmoplantar, Epidermolytic

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue DiseasesPhotosensitivity DisordersBurnsWounds and InjuriesKeratoderma, Palmoplantar, DiffuseKeratoderma, PalmoplantarSkin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Johanna H Hagman, M.D, PhD

    Vaasa Central Hospital, Vaasa, Finland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2022

First Posted

May 2, 2022

Study Start

September 1, 2022

Primary Completion

September 26, 2023

Study Completion

September 26, 2023

Last Updated

October 10, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)