Healthy Subjects
Conditions
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
This clinical investigation intended to test different biocompatible adhesives over time as part of the UNEEG Episight Baseplate construction for UNEEG™ medical A/S
Interventions
DEVICEShort-term Baseplates first then long-term Baseplates
Short-term Baseplates A and B tested for 17/18 days first then long-term Baseplates C and D tested for 17/18 days
DEVICELong-term Baseplates first then short-term Baseplates
Long-term Baseplates C and D tested for 17/18 days first then short-term Baseplates A and B tested for 17/18 days
Sponsors
UNEEG Medical A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
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.
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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin Reactions | 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) |
Countries
Denmark
Participant flow
Pre-assignment details
One subject was enrolled by mistake (and signed informed consent) but was immediately excluded. The subject was enrolled despite having a high degree of dandruff and thus did not have healthy skin as required per the inclusion criteria. This subject was not randomized and did not provide any data.
Participants by arm
| Arm | Count |
|---|---|
| Short-term Baseplates First, Then Long-term Baseplates Started with 1-day use adhesives for 17-18 days:
Type A: Acrylate behind one ear and Type B: YUKI-gel behind the other ear.
Subsequently tested 4-days use adhesives for 17-18 days:
Type C: Hydrocolloid behind one ear and Type D: Silicone behind the other ear | 16 |
| Short-term Baseplates First, Then Long-term Baseplates Started with 1-day use adhesives for 17-18 days:
Type A: Acrylate behind one ear and Type B: YUKI-gel behind the other ear.
Subsequently tested 4-days use adhesives for 17-18 days:
Type C: Hydrocolloid behind one ear and Type D: Silicone behind the other ear | 32 |
| Long-term Baseplates First, Then Short-term Baseplates Started with 4-days use adhesives for 17-18 days:
Type C: Hydrocolloid behind one ear and Type D: Silicone behind the other ear.
Subsequently tested 1-day use adhesives for 17-18 days:
Type A: Acrylate behind one ear and Type B: YUKI-gel behind the other ear. | 17 |
| Long-term Baseplates First, Then Short-term Baseplates Started with 4-days use adhesives for 17-18 days:
Type C: Hydrocolloid behind one ear and Type D: Silicone behind the other ear.
Subsequently tested 1-day use adhesives for 17-18 days:
Type A: Acrylate behind one ear and Type B: YUKI-gel behind the other ear. | 34 |
| Total | 99 |
Baseline characteristics
| Characteristic | Long-term Baseplates First, Then Short-term Baseplates | Total | Short-term Baseplates First, Then Long-term Baseplates |
|---|---|---|---|
| Age, Continuous | 45 years | 32 years | 24.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 29 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 16 Participants | 26 Participants | 10 Participants |
| Sex: Female, Male Female | 11 Participants | 18 Participants | 7 Participants |
| Sex: Female, Male Male | 6 Participants | 15 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 32 | 0 / 33 | 0 / 33 |
| other Total, other adverse events | 22 / 32 | 15 / 32 | 29 / 33 | 26 / 33 |
| serious Total, serious adverse events | 0 / 32 | 0 / 32 | 0 / 33 | 0 / 33 |
Outcome results
Primary
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.
Time frame: 17-18 days
Population: Participants with at least one TEWL measurement following use of the given baseplate type
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Short-term Baseplate Type A: Acrylate | Trans Epidermal Water Loss (TEWL) to Measure Skin-friendliness | Test area | 20.7 g/m²/h | Standard Deviation 11.1 |
| Short-term Baseplate Type A: Acrylate | Trans Epidermal Water Loss (TEWL) to Measure Skin-friendliness | Control area | 7.5 g/m²/h | Standard Deviation 2.1 |
| Short-term Baseplate Type B: YUKI-gel | Trans Epidermal Water Loss (TEWL) to Measure Skin-friendliness | Control area | 7.3 g/m²/h | Standard Deviation 1.8 |
| Short-term Baseplate Type B: YUKI-gel | Trans Epidermal Water Loss (TEWL) to Measure Skin-friendliness | Test area | 8.0 g/m²/h | Standard Deviation 2.4 |
| Long-term Baseplate Type C: Hydrocolloid | Trans Epidermal Water Loss (TEWL) to Measure Skin-friendliness | Test area | 19.3 g/m²/h | Standard Deviation 8 |
| Long-term Baseplate Type C: Hydrocolloid | Trans Epidermal Water Loss (TEWL) to Measure Skin-friendliness | Control area | 7.5 g/m²/h | Standard Deviation 1.8 |
| Long-term Baseplate Type D: Sillicone | Trans Epidermal Water Loss (TEWL) to Measure Skin-friendliness | Test area | 8.0 g/m²/h | Standard Deviation 3 |
| Long-term Baseplate Type D: Sillicone | Trans Epidermal Water Loss (TEWL) to Measure Skin-friendliness | Control area | 7.1 g/m²/h | Standard Deviation 2.3 |
Secondary
Skin Reactions
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)
Time frame: 17-18 days
Population: Participants with at least one skin assessment after use of the given Baseplate type
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Short-term Baseplate Type A: Acrylate | Skin Reactions | 24 Head sides |
| Short-term Baseplate Type B: YUKI-gel | Skin Reactions | 15 Head sides |
| Long-term Baseplate Type C: Hydrocolloid | Skin Reactions | 29 Head sides |
| Long-term Baseplate Type D: Sillicone | Skin Reactions | 26 Head sides |