Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An Open-Label, Single-Center, Single-Treatment, Safety and Effectiveness Evaluation of Percutaneous Radiofrequency in Achieving Submental Lift
Brief Summary:
A prospective evaluation of the ThermiRF device in treating skin laxity under the chin and neck. Seventy male and female subjects between the age of 35 and 65 (inclusive) will be enrolled in this trial. The first 30 subjects will have a total of 6 study visits while the remainder will have a total of 5 study visits.
All subjects will have a single treatment administered. The first 30 subjects will have an extra visit at Day 60 intended to allow collection of photo images post treatment to be used for the validation of three blinded raters.
Photo images will be collected using 2D standard photography and 3D using the Vectra system. The architecture of the skin in the affected area will be measured using the Cutometer, a suction like instrument that measures elasticity. Sensory and safety will be measured using a 0-10 point numerical rating scale (NRS) and collection of safety reports. The study duration is approximately 6 months.