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The purpose of the study is to verify tissue heating, temperature stability and safety of the Nuera Tight RF device during and after treatment session applied on the face.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nuera Tight RF System | Experimental | Subjects will receive an RF treatment session on the periorbital area and cheeks with a frequency of 1 and 4 MHz. Each subject will be treated on one side of the face using a 10 mm capacitive electrode, and on the other side using a 20 mm capacitive electrode. The target temperature will be set at 42 C. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NuEra Tight RF system | Device | monopolar radiofrequency device |
|
| Measure | Description | Time Frame |
|---|---|---|
| tissue heating | To verify tissue heating throughout the treatment duration applied on the face. The temperature will be set at 42 C, the operator will move the electrode in a continuous motion until the skin temperature reached the target temperature, then the treatment will continue for another 12 minutes. the skin temperature will be measured using an infrared thermometer to verify tissue heating | 12 minutes |
| temperature stability | To verify temperature stability throughout the treatment duration applied on the face. the skin temperature will be measured using an infrared thermometer every 3 minutes to verify temperature stability | 12 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy Lewis, MD | Lewis Dermatology & Associates | Principal Investigator |
| Shauna Diggs, MD | Cosmedic Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cosmedic Dermatology | Detroit | Michigan | 48230 | United States | ||
| Lewis Dermatology & Associates |
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| New York |
| New York |
| 10021 |
| United States |