This study is being conducted to evaluate the safety and efficacy of bipolar fractional radiofrequency treatment via use of the Profound System to achieve lift in lax submental (beneath the chin) and neck tissue
A multi-center, blinded, non-randomized, non-controlled study Up to 60 eligible participants will be enrolled at up to three (3) sites. Participants will receive one (1) treatment in the submental/neck area. Participants will complete follow-up visits for clinical evaluation at Day 14, 1 Month, 3 Month, and 6 Months after the study treatment. Standard photography will be obtained at Screening to the 6 Month follow-up, and 3D photography will be obtained at Screening, Month 3, and Month 6 visit.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Bipolar radiofrequency (RF) travels from the RF generator, through the electrodes and into the dermal layers beneath the surface of the skin. The microneedles of the Dermal and SubQ cartridges coupled with thermal heat will stimulate neocollagenesis and neoelastosis, aiding in the reduction of submental laxity.
Candela Institute of Excellence
Marlborough, Massachusetts, United States
Change in submental skin laxity
Improvement in overall lifting of treated tissue in the submental/neck region via blinded evaluation of Baseline (pre-procedure) and Day 180 (post-procedure) photographs
Time frame: Baseline - Day 180 (6 months post-treatment)
Occurrence, severity, and relatedness of adverse events
The number and level of severity of adverse events after device treatment. An assessment will also be made to determine if the adverse event is related to the study devices and/or procedure
Time frame: Baseline - Day 180 (6 months post-treatment)
Change in submental skin laxity
Improvement in overall lifting of treated tissue in the submental/neck region via blinded evaluation of Baseline (pre-procedure) and Day 90 (post-procedure) photographs
Time frame: Baseline - Day 90 (3 months post-treatment)
Surface Area Assessment to demonstrate percentage of participants having improvement in tissue lift (> 20mm2 in submental and neck skin laxity)
Change in submental and neck skin laxity via 3D photo-analysis
Time frame: Baseline vs. Day 180
Subject assessment of improvement in skin laxity
Improvement in skin laxity scored by subject using a 5-point Global Aesthetic Improvement Score (1=Very Much Improved, 5=Worse)
Time frame: 3 Month Follow-Up and 6 Month Follow-Up
Subject satisfaction of treatment results: Subject Satisfaction scale
Using a Subject Satisfaction scale, subjects will score satisfaction of treatment results (1=Not Satisfied, 5=Very Satisfied). Lower scores will show worse outcomes and higher scores will show better outcomes.
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Time frame: Day 14 - 6 Month Follow-Up
Subject assessment of pain: Numerical Pain Rating Scale
The subjects' assessment of pain will be completed using an 11-point Numerical Pain Rating Scale (0=No pain, 10=extreme pain)
Time frame: Treatment Visit