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The goal of the Radiofrequency microneedling devices (Potenza and Morpheus) used in this study is to collect clinical data for dermatologic conditions in which electrocoagulation and hemostasis is a viable mechanism for means of improvement.
Up to 20 subjects will be enrolled at 1 study center. Subjects will be enrolled into one of 2 groups. Group A will receive split face treatments with the Potenza and Morpheus. Group B will receive treatments on the face, abdomen, and/or back with Potenza and/or Morpheus. Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects will receive up to 3 treatments with Potenza (and Morpheus).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A- Split face | Experimental | Group A will receive split face treatments with the Potenza and Morpheus. Randomization will not be used for enrolling subjects to a group but will be used for Group A to determine which side of the face will receive which device. |
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| Group B- none split face | Experimental | Group B will receive treatments on the face, abdomen, and/or back with Potenza and/or Morpheus. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Potenza | Device | The Radiofrequency microneedling device will be used for treating several skin problems. It is mostly used on the face and neck, specifically to treat jowls and firm the jawline, under aye area, and around the mouth. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum pain reported during treatment. | The maximum pain during treatment per each device will be reported on a scale of 0 (none) to 10 (maximum intolerable pain). | procedure (during device treatment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sean Doherty | Cynosure, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cynosure, Inc | Westford | Massachusetts | 01886 | United States |
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Subjects will be treated with the Potenza device on one side of the face and will receive treatment with Morpheus device on the other side of the face.
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Subjects do not know which side of the face will be treated with either of the devices.
| Morpheus | Device | The Radiofrequency microneedling device will be used for treating several skin problems. It is mostly used on the face and neck, specifically to treat jowls and firm the jawline, under aye area, and around the mouth. |
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