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

NCT05111847 | Completed Results

• 1 other identifier: U009 Part I
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

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 reflects unhealthy skin, i.e. high loss of water that passes from inside a body through the epidermis.

  17-18 days

Secondary Outcomes (1)

• Skin Reactions

  17-18 days

Study Arms (2)

Short-term Baseplates first then long-term Baseplates

OTHER

Short-term Baseplates - Type A: Acrylate Type B: YUKI-gel Long-term Baseplates - Type C: Hydrocolloid Type D: Silicone

Device: Short-term Baseplates first then long-term Baseplates

Long-term Baseplates first then short-term Baseplates

OTHER

Long-term Baseplates - Type C: Hydrocolloid Type D: Silicone Short-term Baseplates - Type A: Acrylate Type B: YUKI-gel

Device: Long-term Baseplates first then short-term Baseplates

Interventions

Short-term Baseplates first then long-term Baseplates DEVICE

Short-term Baseplates A and B tested for 17/18 days first then long-term Baseplates C and D tested for 17/18 days

Short-term Baseplates first then long-term Baseplates

Long-term Baseplates first then short-term Baseplates DEVICE

Long-term Baseplates C and D tested for 17/18 days first then short-term Baseplates A and B tested for 17/18 days

Long-term Baseplates first then short-term Baseplates

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

Limitations and Caveats

The study did not have a formal power and sample size calculation. Some skin reactions were reported both as an ADE and separately in the "skin reaction questionnaire". When recording objective skin measurements, particularly TEWL, it is important that the room conditions, such as temperature and humidity, which may have affected the skin measurements. However, all TEWL measurements were within acceptable range.

Results Point of Contact

• Title: Clinical Operations, Medical Affairs
• Organization: UNEEG medical

LYBL@uneeg.com

+45 41414244

Study Officials

• Tonny Karlsmark, Dr.

  Bispebjerg Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Model Details: In Part I of the study, the baseplates type A, B, C and D were tested on the skin behind the ears. Each subject tested either 1) short-term baseplates A and B first for 17/18 days and then long-term baseplates C and D for 17/18 days or 2) long-term baseplates C and D first for 17/18 days and then short-term baseplates A and B for 17/18 days.

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: November 8, 2021
• Study Start: October 12, 2021
• Primary Completion: June 23, 2022
• Study Completion: June 23, 2022
• Last Updated: January 14, 2026
• Results First Posted: January 14, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)