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

NCT05356572 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2023-10-10

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

Investigational Skin Preparation Device

Removal of hyperkeratotic skin with Investigational Skin Preparation Device

DEVICE

GMDN 47102 / Electrode Skin Abrasive Pad

Removal of hyperkeratotic skin with Abrasive Pad for Skin Preparation

DEVICE

UMDNS 13-230 / Biopsy punch (Dermal Curette)

Removal of hyperkeratotic skin with Disposable Dermal Curette

Sponsors & Collaborators

  • Clinius Ltd

    collaborator INDUSTRY

  • Mirka Ltd

    lead INDUSTRY

Principal Investigators

  • Johanna H Hagman, M.D, PhD · Vaasa Central Hospital, Vaasa, Finland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2023-09-26
Completion
2023-09-26

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05356572 on ClinicalTrials.gov