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| Name | Class |
|---|---|
| Cutera Inc. | INDUSTRY |
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To evaluate the efficacy of novel noninvasive RF technology for reduction of submental fat.
Recently, Novel radiofrequency (RF) technology was introduced as a promising tool for non-invasive body and face contouring, which can heats subcutaneous fat up to 45℃ continuously without surface damage and induces adipocytes apoptosis.
Subjects with an excessive subcutaneous fat on the submental area received twice treatments at 1-month intervals. Clinical outcomes including the thickness of the submental fat (measured by ultrasound) and the submental circumference (measured by a tape measure), and clinical photographs were obtained at baseline, and 1-month and 6-month after last treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants | Experimental | Noninvasive Radiofrequency |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Noninvasive Radiofrequency TruSculpt | Procedure | Heating subcutaneous fat up to 45℃ continuously at least 3 minutes without surface damage and induces adipocytes apoptosis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in thickness of the submental fat at 6 months | thickness of the submental fat measured by ultrasound | 6 months |
| Change from Baseline in submental circumference at 6 months | thickness of the submental fat measured by a tape measure | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| participants' assessment for improvement at 6 months | assessment for improvement by participants | 6 months |
| participants' assessment for satisfaction at 6 months | assessment for satisfaction by participants |
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Inclusion Criteria:
Exclusion Criteria:
any infectious or inflammatory skin diseases
keloids
psychiatric patients
systemic underlying disease
who had taken aesthetic procedure on the face, before 6-month
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| Name | Affiliation | Role |
|---|---|---|
| Won-Serk Kim, M.D., Ph.D. | Kangbuk Samsung Hospital | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20583242 | Background | Franco W, Kothare A, Ronan SJ, Grekin RC, McCalmont TH. Hyperthermic injury to adipocyte cells by selective heating of subcutaneous fat with a novel radiofrequency device: feasibility studies. Lasers Surg Med. 2010 Jul;42(5):361-70. doi: 10.1002/lsm.20925. | |
| 20014265 | Background | Franco W, Kothare A, Goldberg DJ. Controlled volumetric heating of subcutaneous adipose tissue using a novel radiofrequency technology. Lasers Surg Med. 2009 Dec;41(10):745-50. doi: 10.1002/lsm.20876. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 31, 2015 | |
| Reset | Sep 30, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 31, 2015 | Sep 30, 2015 |
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| 6 months |