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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Monopolar radiofrequency will be applied through the Thermage FLX machine to the subject's right lower jaw and submentum area.
Riverchase Dermatology
Miami, Florida, United States
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.
Time frame: 12 weeks
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.
Time frame: 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.
Time frame: though study completion, up to 12 weeks
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