NCT05111847

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

Completed NA Results posted Last updated 14 January 2026

What this trial tests

NA trial testing Short-term Baseplates first then long-term Baseplates in Healthy Subjects in 34 participants. Completed in 23 June 2022.

Timeline

12 October 2021

Primary endpoint
23 June 2022

23 June 2022

Quick facts

Lead sponsor	UNEEG Medical A/S
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	basic science
Enrollment	34
Start date	12 October 2021
Primary completion	23 June 2022
Estimated completion	23 June 2022
Sites	1 location across Denmark

Drugs / interventions tested

• Short-term Baseplates first then long-term Baseplates
• Long-term Baseplates first then short-term Baseplates

Conditions studied

• Healthy Subjects — all drugs for Healthy Subjects →

Sponsor

UNEEG Medical A/S

Who can join

Adults 18 to 120, any sex, with Healthy Subjects. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Trans Epidermal Water Loss (TEWL) to Measure Skin-friendliness Primary · 17-18 days

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.

Test area

Group	Value	95% CI
Short-term Baseplate Type A: Acrylate	20.7	± 11.1
Short-term Baseplate Type B: YUKI-gel	8.0	± 2.4
Long-term Baseplate Type C: Hydrocolloid	19.3	± 8.0
Long-term Baseplate Type D: Sillicone	8.0	± 3.0

Control area

Group	Value	95% CI
Short-term Baseplate Type A: Acrylate	7.5	± 2.1
Short-term Baseplate Type B: YUKI-gel	7.3	± 1.8
Long-term Baseplate Type C: Hydrocolloid	7.5	± 1.8
Long-term Baseplate Type D: Sillicone	7.1	± 2.3

Skin Reactions Secondary · 17-18 days

Systematic assessment (visual inspection by investigator and self-reporting by participant via daily questionnaires). Some skin reactions were also reported as adverse device effects (see Adverse Event section)

Group	Value	95% CI
Short-term Baseplate Type A: Acrylate	24
Short-term Baseplate Type B: Yuki-gel	15
Long-term Baseplate Type C: Hydrocolloid	29
Long-term Baseplate Type D: Silicone	26

Adverse events — posted to ClinicalTrials.gov

Time frame: From enrollment until follow-up, 35-42 days. Each baseplate type tested for 17-18 days.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Short-term Baseplate Type A: Acrylic

Serious: 0/32 (0%)

Deaths: 0/32

Short-term Baseplate Type B: Yuki-gel

Serious: 0/32 (0%)

Deaths: 0/32

Long-term Baseplate Type C: Hydrocolloid

Serious: 0/33 (0%)

Deaths: 0/33

Long-term Baseplate Type D: Silicone

Serious: 0/33 (0%)

Deaths: 0/33

Other adverse events (2 terms — click to expand)

Reaction	System	Short-term Baseplate Type …	Short-term Baseplate Type …	Long-term Baseplate Type C…	Long-term Baseplate Type D…
Skin reaction	Skin and subcutaneous tissue disorders	—	—	—	—
Discomfort, pain, headache	General disorders	—	—	—	—

Data from ClinicalTrials.gov NCT05111847 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Clinical Measurement of Transepidermal Water Loss.
   Kundu D, Jayaraman A, Sen CK. · · 2026 · cited 4× · PMID 40476522 · DOI 10.1089/wound.2024.0148