Healthy Subjects
Conditions
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.
Detailed description
This clinical investigation intended to test different biocompatible adhesives over time as part of the UNEEG Episight Baseplate construction for UNEEG™ medical A/S. The two Baseplates reported on in this registration, is a follow-up to an initial testing of four different types of adhesive i.e., four types of Baseplates. This study is Part II of the protocol. Part I is registered: NCT05111847
Interventions
DEVICEBaseplate type A
Type A: Acrylate tested for 35 days behind one ear
DEVICEBaseplate type C
Type C: Hydrocolloid tested for 35 days behind the other ear
Sponsors
UNEEG Medical A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trans epidermal water loss (TEWL) to measure skin-friendliness | 35 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 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. |
Countries
Denmark
Outcome results
None listed