Evaluation of a Novel Bimodal-Approach Radiofrequency Device for Lower Facial Tightening in Southeast Asian Patients: An Open-Label Prospective Study.

BACKGROUND: Radiofrequency (RF) devices are employed for noninvasive facial rejuvenation. A novel bimodal RF system delivers monopolar and bipolar energy sequentially within a single shot to enhance efficacy and safety.
OBJECTIVES: To evaluate the safety and efficacy of a bimodal-RF device, DENSITY Noir (Jeisys Med Inc., Seoul, Republic of Korea), for the treatment of lower facial laxity.
METHODS: This prospective, open-label clinical study enrolled 26 adults (n = 26; 30-60 years) with mild-to-moderate lower facial laxity. All participants received a single RF treatment session with DENSITY Noir. Outcomes were assessed using investigator and participant global assessments, the Facial Laxity Rating Scale, and 3D Antera imaging for nasolabial fold parameters, together with texture and brown spot measured by VISIA. Safety and tolerability were monitored throughout the study. Statistical analyses included Friedman and Wilcoxon tests, marginal homogeneity tests, and linear mixed-effects model tests.
RESULTS: Twenty-three (n = 23) participants completed follow-up. Nearly half (47.83%) achieved marked improvement (51%-75%) on the 6-point global improvement scale at 6 months. Facial laxity ratings significantly improved at 1, 3, and 6 months vs. baseline (p < 0.001). Antera analysis confirmed significant reductions in nasolabial fold cross-sectional area (baseline: 41.94; 1 month: 38.87; 3 months: 39.63; 6 months: 35.72; p = 0.02) and wrinkle width (baseline: 1.98 mm; 6 months: 1.85 mm; p = 0.01). About 78% of participants reported high satisfaction at 6 months. Adverse effects included transient erythema (96.15%), edema (61.53%), and mild procedural pain; all adverse events were minor, transient, and self-limiting.
CONCLUSIONS: DENSITY Noir was associated with significant improvement in lower facial laxity with a favorable safety and tolerability profile in this cohort. Further controlled studies are warranted to confirm efficacy and durability.
TRIAL REGISTRATION: ClinicalTrials.gov identifier: TCTR20250924004.