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A disposable, air-activated, adhesive backed heat patch is being developed to provide temporary relief from minor muscular ache and joint pains associated with overexertion strains and sprains as well as minor pain associated with arthritis. The aim of the study is to determine the safety and tolerability of the patch during normal wear conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thermal Adhesion Patch | Experimental | Group of subjects wearing the experimental patch for 8 hour study duration |
|
| Marketed Thermal Adhesion Patch | Active Comparator | Group of subjects wearing comparative predicate device for 8 hour study duration. |
|
| Placebo Patch | Placebo Comparator | Group of subjects wearing the placebo patch for 8 hour study duration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thermal Adhesion Patch | Device |
| ||
| Marketed Thermal Adhesion 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. | 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Adhesion Evaluation | Adhesion will be evaluated to a predetermined scale when the subjects return for visit 3 after approximately 8 hours of wear time. | 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 27, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 7, 2023 | Dec 27, 2023 |
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| Device |
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| Placebo Patch | Device |
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