Subsurface thermistor-controlled monopolar radiofrequency (SMRF) is an emerging technology designed to offer a minimally invasive option for tightening of lax skin. The versatility of this technique allows it to be applied to virtually any body site.
The purpose of this study is to evaluate the safety and efficacy of SMRF for tightening of posterior upper arm skin laxity.
This is a prospective, open-label clinical trial involving 12 subjects aged 18 to 65 with moderate-to-severe skin laxity in the posterior upper arms.
Each subject received treatment to the bilateral arms resulting in a population of n = 24 arms in the analysis group. Treatment consisted of SMRF delivered at Day 0 of the trial. Follow-up evaluation was conducted at Day 7, 30, and 90 post-treatment. The primary end point was the assessment of skin laxity by a nontreating physician utilizing a standardized 5 point Skin Laxity Grading Scale at baseline, Days 30 and 90. Subject self-evaluation of firmness, laxity, texture, and satisfaction was also collected. Circumferential and vertical arm measurements were obtained via digital fractional caliper. An adverse event profile was categorized.
Significant improvements in skin laxity were observed at both Day 30 and at Day 90 post-treatment as assessed by the nontreating investigator. Subjects also rated significant improvements in the firmness, texture, and laxity of their treated arms. The majority of subjects were “satisfied” to “extremely satisfied” with their results. Adverse events recorded at Day 7 post-treatment included erythema (4%), contour irregularity (4%), and bruising (13%). All adverse events resolved completely by Day 30 post-treatment.
Thermistor-controlled SMRF is a safe and effective means to treating posterior upper arm skin laxity.