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

NACompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

September 1, 2022

Primary Completion Date

September 26, 2023

Study Completion Date

September 26, 2023

Conditions
Keratosis, ActinicActinic LesionSolar Keratosis/SunburnHyperkeratosisHyperkeratotic CallusHyperkeratotic; LesionHyperkeratotic 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

Trial Locations (1)

65130

Vaasa Central Hospital, Vaasa

All Listed Sponsors
collaborator

Clinius Ltd

INDUSTRY

lead

Mirka Ltd

INDUSTRY