OBJECTIVES: To quantify the improvements in laxity from the surgical face-lift and to perform a randomized, blinded comparison with the clinical effects of a novel, minimally invasive fractional radiofrequency (FRF) system. STUDY DESIGN: Randomized, blinded, comparative trial. PATIENTS: Fifteen sequential patients with facial skin laxity enrolled in the trial and completed FRF treatment and follow-up. Baseline and follow-up digital photographs of patients undergoing FRF were randomly mixed with 6 sets of baseline and follow-up images of patients undergoing surgical face-lift with equivalent baseline facial laxity grades. MAIN OUTCOME MEASURES: Five independent blinded evaluators graded randomized baseline and 3- to 6-month follow-up photographs using a comprehensive quantitative 4-point laxity grading scale. Quantitative changes in laxity grades were calculated and compared statistically for FRF treatment vs surgical face-lifts. Patient satisfaction and adverse events were also evaluated. RESULTS: Blinded grading of unmarked, randomized baseline and follow-up photographs of patients undergoing FRF treatment randomized with baseline and follow-up photographs of patients undergoing surgical face-lift demonstrated statistically significant improvement in facial laxity, with a mean grade improvement of 1.20 for patients in the surgical face-lift group and of 0.44 for FRF-treated patients on a 4-point laxity grading scale (P < .001). The improvements relative to baseline were 16% for FRF treatment compared with 49% for the surgical face-lift. The mean laxity improvement from a single FRF treatment was 37% that of the surgical face-lift. Patient satisfaction was high (dissatisfied, 0%; neutral, 7%; satisfied, 60%; and very satisfied, 33%). All participants in the FRF treatment group experienced transient erythema, mild edema, and mild to moderate purpura that resolved in 5 to 10 days, and they returned to normal activities within 24 hours. There were no adverse events or complications in the FRF group. All patients in the surgical face-lift group experienced scarring at surgical margins, erythema, edema, and ecchymosis, and they returned to normal activities on suture removal at 7 to 10 days. CONCLUSIONS: This randomized, blinded, quantitative assessment using a validated grading scale of skin laxity improvement from the gold standard treatment, the surgical face-lift, and comparative analysis to a novel, minimally invasive FRF treatment has demonstrated 49% improvement in skin laxity relative to baseline for the surgical face-lift, compared with 16% for FRF. The surgical face-lift resulted in a mean 1.20-grade improvement on the 4-point laxity grading scale. In comparison, a single, minimally invasive FRF treatment demonstrated a 0.44-laxity grade improvement, or 37% that of the surgical face-lift, without the adverse effects and complications of surgical procedures. This study provides a basis for quantifying cosmetic outcomes from novel treatments with comparative analysis to the gold standard. It also suggests that minimally invasive FRF treatment may provide an important nonsurgical option for the treatment of facial skin laxity.
RCT Entities:
OBJECTIVES: To quantify the improvements in laxity from the surgical face-lift and to perform a randomized, blinded comparison with the clinical effects of a novel, minimally invasive fractional radiofrequency (FRF) system. STUDY DESIGN: Randomized, blinded, comparative trial. PATIENTS: Fifteen sequential patients with facial skin laxity enrolled in the trial and completed FRF treatment and follow-up. Baseline and follow-up digital photographs of patients undergoing FRF were randomly mixed with 6 sets of baseline and follow-up images of patients undergoing surgical face-lift with equivalent baseline facial laxity grades. MAIN OUTCOME MEASURES: Five independent blinded evaluators graded randomized baseline and 3- to 6-month follow-up photographs using a comprehensive quantitative 4-point laxity grading scale. Quantitative changes in laxity grades were calculated and compared statistically for FRF treatment vs surgical face-lifts. Patient satisfaction and adverse events were also evaluated. RESULTS: Blinded grading of unmarked, randomized baseline and follow-up photographs of patients undergoing FRF treatment randomized with baseline and follow-up photographs of patients undergoing surgical face-lift demonstrated statistically significant improvement in facial laxity, with a mean grade improvement of 1.20 for patients in the surgical face-lift group and of 0.44 for FRF-treated patients on a 4-point laxity grading scale (P < .001). The improvements relative to baseline were 16% for FRF treatment compared with 49% for the surgical face-lift. The mean laxity improvement from a single FRF treatment was 37% that of the surgical face-lift. Patient satisfaction was high (dissatisfied, 0%; neutral, 7%; satisfied, 60%; and very satisfied, 33%). All participants in the FRF treatment group experienced transient erythema, mild edema, and mild to moderate purpura that resolved in 5 to 10 days, and they returned to normal activities within 24 hours. There were no adverse events or complications in the FRF group. All patients in the surgical face-lift group experienced scarring at surgical margins, erythema, edema, and ecchymosis, and they returned to normal activities on suture removal at 7 to 10 days. CONCLUSIONS: This randomized, blinded, quantitative assessment using a validated grading scale of skin laxity improvement from the gold standard treatment, the surgical face-lift, and comparative analysis to a novel, minimally invasive FRF treatment has demonstrated 49% improvement in skin laxity relative to baseline for the surgical face-lift, compared with 16% for FRF. The surgical face-lift resulted in a mean 1.20-grade improvement on the 4-point laxity grading scale. In comparison, a single, minimally invasive FRF treatment demonstrated a 0.44-laxity grade improvement, or 37% that of the surgical face-lift, without the adverse effects and complications of surgical procedures. This study provides a basis for quantifying cosmetic outcomes from novel treatments with comparative analysis to the gold standard. It also suggests that minimally invasive FRF treatment may provide an important nonsurgical option for the treatment of facial skin laxity.
Authors: Claudia A Hernandez; Michael Alfertshofer; Konstantin Frank; Lysander Freytag; Diana L Gavril; Kristina Davidovic; Robert H Gotkin; Arnaldo Mercado-Perez; Samir Mardini; Sebastian Cotofana Journal: Aesthetic Plast Surg Date: 2022-06-01 Impact factor: 2.326