Effectiveness of Sequential Monopolar and Bipolar Radiofrequency Device for Facial Rejuvenation in Female Participants

Background and rationale Facial aging involves changes across several skin layers, including loss and disorganization of collagen and elastin, thinning of the dermis, and changes in deeper soft tissue. These changes appear as skin laxity, wrinkles, enlarged pores, and uneven texture. Radiofrequency (RF) devices deliver controlled thermal energy to the dermis, causing immediate collagen contraction followed by new collagen formation and tissue remodeling. Conventional RF systems typically use a single mode and treat a single tissue depth, which may not address changes occurring in both superficial and deeper layers at the same time. Monopolar RF produces broader, deeper volumetric heating, while bipolar RF produces more localized heating in superficial tissue. Delivering both modes sequentially in one session may stimulate remodeling across multiple tissue depths. Prospective clinical evidence for this sequential approach is limited, and few RF studies combine quantitative 3D imaging with validated patient-reported outcome measures. Study device and procedure The study device is the DENSITY RF system (Jeisys Medical Inc., Seoul, South Korea), operating at 6.78 megahertz (MHz) with sequential monopolar and bipolar delivery using Classic-F and High-F tips. A neutral grounding electrode is used during monopolar delivery. Each participant receives a single treatment session to the face and neck, administered by trained clinic personnel at an energy setting of approximately 3.0 to 3.5 over two passes (approximately 300 shots). The clinical endpoint is uniform mild erythema with a comfortable warming sensation. Topical anesthetic is applied where needed, and participants are observed for 15 to 30 minutes after treatment. Study design and visit schedule This is a prospective, single-center, single-arm, baseline-controlled pilot study conducted at Cutis Medical Laser Clinics, Singapore. Each participant takes part for approximately 3 months: * Visit 1 (Day 1): screening, baseline assessments, treatment, and immediate post-treatment tolerability assessment * Visit 2 (Day 30 +/- 5 days): follow-up assessments * Visit 3 (Day 90 +/- 5 days): final follow-up assessments Assessments include standardized three-dimensional (3D) facial imaging (AURA 3D Imaging System), FACE-Q patient-reported outcome scales, investigator-assessed skin laxity grading, investigator- and participant-rated Global Aesthetic Improvement Scale (GAIS), local skin tolerability, and adverse event monitoring. Participants are asked to maintain their usual skincare routine and avoid other aesthetic treatments or new topical products during the study. Statistical considerations As a pilot study, analyses are primarily descriptive. Changes from baseline are evaluated using paired t-tests or Wilcoxon signed-rank tests as appropriate, with two-sided significance set at p\<0.05. Ethics and conduct The study is conducted in accordance with International Council for Harmonisation Good Clinical Practice (ICH-GCP), International Organization for Standardization (ISO) 14155:2020, the Declaration of Helsinki, and the Singapore Human Biomedical Research Act. The protocol was approved by the Parkway Independent Ethics Committee (PIEC), reference PIEC/2025/047. Written informed consent is obtained from all participants before any study procedure.