Safety and Performance of Short- and Long-term Baseplates for Attaching the UNEEG Episight Recorder - Part II

NCT06934005 | Completed

• 1 other identifier: U009 Part II
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical investigation is to test the safety and performance of one short- and one long-term Baseplate constructed with different types of biocompatible adhesives.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• Trans epidermal water loss (TEWL) to measure skin-friendliness

  To evaluate the skin barrier functionality (i.e., skin-friendliness) after repeated use of Baseplates (i.e., adhesives) on the skin behind the ear. High levels of TEWL equates to unhealthy skin = high loss of water that passes from inside a body through the epidermis.High levels of TEWL equates to unhealthy skin = high loss of water that passes from inside a body through the epidermis.

  35 days

Study Arms (1)

Short-term Baseplate A and long-term Baseplate C, concomitant use

OTHER

All participants wore Short-term Baseplate A behind one are and long-term Baseplate C behind the other ear for 35 days.

Device: Baseplate type A; Device: Baseplate type C

Interventions

Baseplate type A DEVICE

Type A: Acrylate tested for 35 days behind one ear

Short-term Baseplate A and long-term Baseplate C, concomitant use

Baseplate type C DEVICE

Type C: Hydrocolloid tested for 35 days behind the other ear

Short-term Baseplate A and long-term Baseplate C, concomitant use

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UNEEG Medical A/S: lead

Study Sites (1)

Dermato-Venerologisk Afdeling og Videncenter for Sårheling, Bispebjerg Hospital

København NV, 2400, Denmark

Location

Study Officials

• Tonny Karlsmark, Dr.

  Bispebjerg Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Following a cross-over design in Part I of the study, two of the four initial Baseplates, is tested for longer wear time (35 days) in this Part II of the study.

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: April 18, 2025
• Study Start: August 22, 2022
• Primary Completion: October 6, 2022
• Study Completion: October 6, 2022
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)