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The purpose of this study is to evaluate the ability of the Serene RF System to effectively improve the appearance of dynamic glabellar lines and sustain the effect for a minimum of 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Serene RF System | Percutaneous delivery of radiofrequency (RF) energy to create a temporary conduction block to the corrugator and/or procerus muscles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serene RF System | Device | The Serene RF System provides percutaneous delivery of radiofrequency (RF) energy to a targeted nerve. |
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| Measure | Description | Time Frame |
|---|---|---|
| The reduction of glabellar lines | The reduction of glabellar lines will be assessed by a panel of 3 independent reviewers with expertise in dermatology and/or plastic surgery of the change in glabellar lines measured from baseline to 3, 6, 9 and 12 months post procedure. Photographs will be presented in a random order and the reviewers will be blinded to whether the photograph is baseline or a follow up. Effectiveness of the procedure is defined by a ≥ 1 point improvement in score (i.e., numerical decrease) on the Mertz Aesthetics Scale™ (Merz Scale) for dynamic glabellar lines. At each time point the severity of the glabellar lines is assessed on a 5 point scale. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events | 3 months | |
| The reduction of glabellar lines | The reduction of glabellar lines will be assessed by a panel of 3 independent reviewers with expertise in dermatology and/or plastic surgery of the change in glabellar lines measured from baseline to 3, 6, 9 and 12 months post procedure. Photographs will be presented in a random order and the reviewers will be blinded to whether the photograph is baseline or a follow up. Effectiveness of the procedure is defined by a ≥ 1 point improvement in score (i.e., numerical decrease) on the Mertz Aesthetics Scale™ (Merz Scale) for dynamic glabellar lines. At each time point the severity of the glabellar lines is assessed on a 5 point scale. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult men and women with moderate to severe glabellar lines
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| Name | Affiliation | Role |
|---|---|---|
| Scott McGill | Vice President Product Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Premier Plastic Surgery | Palo Alto | California | 94306-3811 | United States | ||
| Premier Plastic Surgery |
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| 12 months |
| Subject satisfaction | Subject satisfaction will be assessed by a survey given every 3 months. This survey asks the subject questions to rate on a scale of 0-4 with 0 representing very dissatisfied and 4 representing very satisfied. | 12 months |
| San Mateo |
| California |
| 94401 |
| United States |
| Aesthetic Plastic Surgery | New York | New York | 10025 | United States |
| Reviance Plastic Surgery & Aesthetics Center | Clackamas | Oregon | 97015 | United States |
| Puget Sound Plastic Surgery | Kirkland | Washington | 98033 | United States |