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| Name | Class |
|---|---|
| Bausch Health Americas, Inc. | INDUSTRY |
| Solta Medical | INDUSTRY |
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This study is designed to evaluate the safety and efficacy of sequential use of monopolar radiofrequency on lower face and submental area, followed by cryolipolysis on the submentum and submandibular area for fat reduction and improvement of skin laxity.
This research study will study subjects who have mild to moderate skin laxity on lower jaw and submentum areas. This will be measured by conducting a treatment using the Thermage FLX system on the lower face and submentum area of the participants. Biopsies will be done on several locations throughout the 12 week trial to assess skin laxity through laboratory measures. Finally, the subject will be asked to complete questionnaires to provide satisfaction and tolerability feedback.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional cohort | Experimental | Each subject will serve as their own control. Left side of lower jaw and submental area is control side. Right side of subject's lower jaw and submentum area will receive treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thermage FLX | Device | Monopolar radiofrequency will be applied through the Thermage FLX machine to the subject's right lower jaw and submentum area. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent Adverse Events [Safety and Tolerability] | The primary objective of this study is to evaluate the safety and efficacy of improvement of skin laxity with the use of monopolar radiofrequency (Thermage FLX, Solta Medical) on lower face and submentum areas. Safety is defined as incidence of device- and/or procedure-related adverse events. Qualitative measurement of efficacy by independent blinded evaluators grading randomized baseline and 3 months follow-up photographs using a 4-point skin laxity rating scale. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective clinical evaluation of skin laxity with the use of monopolar radiofrequency treatment on lower face and neck [Efficacy] | Quantitative measurement of efficacy by standardized 2-D and 3-D images with volume difference in cc, height difference in mm, and surface area reduction measures calculations in cm2 using VECTRA H2 (Canfield Scientific, Inc), as well as, by histochemistry evaluation of punch biopsies performed at baseline, 4 weeks and 12 weeks post-procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leyda R Bowes, MD | Riverchase Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riverchase Dermatology | Miami | Florida | 33133 | United States |
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Prospective, single-center, non-randomized, interventional cohort study
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| up to 12 weeks |
| Subject satisfaction of skin laxity treatment on lower face and submentum areas documented in written questionnaire | Subject satisfaction data will be collected at the 12-week final follow-up visit via a written questionnaire. A validated questionnaire using a likert rating scale will be utilized . Score values are 1 to 5, with high numbers meaning better outcomes. | though study completion, up to 12 weeks |