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To assess the safety and tolerability for the extended wear of an experimental air-activated self adhesive patch.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Marketed Thermal Adhesive Patch | Active Comparator | Group of subjects wearing comparative predicate device for 8 hours daily for 7 days. |
|
| Thermal Adhesive Patch | Experimental | Group of subjects wearing the experimental patch for 8 hours daily for 7 days. |
|
| Placebo Patch | Placebo Comparator | Group of subjects wearing the placebo patch for 8 hours daily for 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thermal Adhesive Patch | Device |
| ||
| Marketed Thermal Adhesive Patch |
| Measure | Description | Time Frame |
|---|---|---|
| Irritation Evaluation | A trained skin grader will apply a predetermined scale to the observed skin reactions in the test areas under light supplied by a 100-watt incandescent blue bulb. | 7 days - 8 hours each day |
| Measure | Description | Time Frame |
|---|---|---|
| Adhesion Evaluation | Adhesion will be evaluated to a predetermined scale when the subjects return for visits; after approximately 8 hours of wear time. | after 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Heat Intensity | Assessed using thermocouple sensors worn between the patch and subject's skin with readings taken every 15 minutes. | 8 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel J Hogan, MD | Radiant Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiant Research, Inc | Pinellas Park | Florida | 33781 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 7, 2023 | |
| Reset | Dec 22, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 7, 2023 | Dec 22, 2023 |
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| Device |
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| Placebo Patch | Device |
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