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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.
This clinical investigation intended to test different biocompatible adhesives over time as part of the UNEEG Episight Baseplate construction for UNEEG™ medical A/S
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 17-18 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tonny Karlsmark, Dr. | Bispebjerg Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermato-Venerologisk Afdeling og Videncenter for Sårheling, Bispebjerg Hospital | København NV | 2400 | Denmark |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First intervention (17-18 days) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 16, 2022 | Apr 10, 2025 |
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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.
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| 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 |
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. |
| COMPLETED |
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| NOT COMPLETED |
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| Second intervention (17-18 days) |
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All enrolled participants in compliance with in- and exclusion criteria
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Head sides |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | All enrolled participants in compliance with in- and exclusion criteria | Median | Full Range | years | Participants |
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| Sex: Female, Male | All enrolled participants in compliance with in- and exclusion criteria | Count of Participants | Participants | Participants |
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| Ethnicity (NIH/OMB) | All enrolled participants in compliance with in- and exclusion criteria | Count of Participants | Participants | Participants |
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| Race (NIH/OMB) | All enrolled participants in compliance with in- and exclusion criteria | Count of Participants | Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants with at least one TEWL measurement following use of the given baseplate type | Posted | Mean | Standard Deviation | g/m²/h | 17-18 days | Head sides | Head sides |
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| 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) | Participants with at least one skin assessment after use of the given Baseplate type | Posted | Number | Head sides | 17-18 days | Head sides | Head sides |
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From enrollment until follow-up, 35-42 days. Each baseplate type tested for 17-18 days.
Adverse device effects (ADEs) were categorized according to International Medical Device Regulators Forum (IMDRF). Skin reactions reported by visual inspection and daily questionnaires were also collected as a secondary endpoint separate from adverse event registration (see Outcome Measures).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Short-term Baseplate Type A: Acrylic | Short-term Baseplate type A tested behind one ear for 17-18 days | 0 | 32 | 0 | 32 | 22 | 32 |
| EG001 | Short-term Baseplate Type B: Yuki-gel | Short-term Baseplate type B tested behind one ear for 17-18 days | 0 | 32 | 0 | 32 | 15 | 32 |
| EG002 | Long-term Baseplate Type C: Hydrocolloid | Long-term Baseplate type C tested behind one ear for 17-18 days | 0 | 33 | 0 | 33 | 29 | 33 |
| EG003 | Long-term Baseplate Type D: Silicone | Long-term Baseplate type D tested behind one ear for 17-18 days | 0 | 33 | 0 | 33 | 26 | 33 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin reaction | Skin and subcutaneous tissue disorders | IMDRF + manual | Systematic Assessment |
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| Discomfort, pain, headache | General disorders | IMDRF + manual | Systematic Assessment |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations, Medical Affairs | UNEEG medical | +45 41414244 | LYBL@uneeg.com |
| Prot_000.pdf |
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Head sides |
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| Control area |
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| Units | Counts |
|---|---|
| Participants |
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| Head sides |
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