Safety and Performance of Short- and Long-term Baseplates for Attaching the Marco Recorder

Not Applicable

Completed

• Conditions: Healthy Subjects

• Registration Number: NCT05111847
• Lead Sponsor: UNEEG Medical A/S

Brief Summary

The purpose of this clinical investigation is to test the safety and performance of short- and longterm Baseplates constructed with different types of biocompatible adhesives.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-07
• Study Start: 2021-10-12
• Study First Submitted QC: 2021-10-26
• Study First Posted: 2021-11-08
• Primary Completion: 2022-10-06
• Study Completion: 2022-10-06
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Informed consent obtained, and letter of authority signed before any study related activities
• Are at least 18 years of age and have full legal capacity
• Healthy skin behind the ear

Exclusion Criteria

• Pregnant or breastfeeding
• Known allergic responses to the adhesives
• Treatment with corticosteroids, either as a cream in the area behind the ear or systemically (tablet or injection) within the last month
• Subject is unable or does not have the necessary assistance to properly operate the device system

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Trans epidermal water loss (TEWL) to measure skin-friendliness	up to 35 days	To evaluate the skin barrier functionality (i.e., skin-friendliness) after repeated use of two types of Baseplates (i.e., adhesives) on the skin behind the ear.

Trial Locations

Locations (1)

Dermato-Venerologisk Afdeling og Videncenter for Sårheling, Bispebjerg Hospital; 🇩🇰 København NV, Denmark