Efficacy and Safety of a Novel Monopolar Radiofrequency Device for Mid and Lower Face Rejuvenation

Efficacy and Safety of a Novel Monopolar Radiofrequency Device for Mid and Lower Face Rejuvenation: A Retrospective Pre-Post Comparative Study

The aim of this study is to evaluate the efficacy and safety of mid- and lower-face lifting and contouring treatments using the novel monopolar radiofrequency device, NeoSculpt.

Study Overview

• Status: Completed
• Conditions: Medical Devices; Rejuvenation; Lifting Efficacy
• Intervention / Treatment: Device: NeoSculpt

Detailed Description

Aging of the face progresses through complex structural changes, including a decrease in skin elasticity, collagen loss, changes in subcutaneous fat distribution, and relaxation of the superficial musculoaponeurotic system (SMAS). These changes are particularly prominent in the mid and lower face, which has led to the widespread use of non-invasive energy-based lifting and contouring procedures in cosmetic and dermatology clinical practices.

Traditional laser and high-output radiofrequency (RF) based lifting treatments generally deliver brief high-temperature energy (over 70°C) to tissues, inducing protein denaturation and coagulation, followed by collagen remodeling through the wound healing process to achieve long-term effects. Although these treatments can induce relatively rapid clinical changes, side effects such as pain during the procedure, as well as erythema, edema, and blisters, which are associated with thermal damage, have been reported.

To address these limitations, there has been increasing interest in low-temperature-maintaining RF treatments that minimize tissue degeneration while inducing biological responses. In particular, RF stimulation in the range of 43-45°C is known to be a temperature range that does not induce tissue coagulation and is believed to trigger reactions related to cellular metabolic activation and programmed cell death (apoptosis), rather than necrosis-based damage with accompanying acute inflammatory responses. This approach has advantages, including relatively less pain, shorter recovery times, and the possibility of repeated treatments.

Recent studies have also reported that TRPV1 receptors, activated by thermal stimulation above 43°C, may be associated not only with pain transmission but also with the activation of fibroblasts, regulation of collagen and extracellular matrix (ECM) synthesis, and regulation of adipocyte metabolism. Some experimental studies have observed an increase in fibroblast proliferation and ECM production when RF energy was applied to maintain a temperature range of 43-45°C for a certain period. However, this evidence has been largely limited to studies focusing on the skin layer, and there is still limited systematic human research on the clinical efficacy and safety of RF treatments that simultaneously stimulate both the skin and subcutaneous fat layers.

NeoSculpt is a monopolar RF system designed with a multi-channel handpiece structure using different frequencies (1 MHz and 2 MHz) to deliver energy progressively to the dermal-SMAS interface and subcutaneous fat layers. Through a low-temperature-maintaining RF protocol, it is expected to achieve mid- and lower-face lifting and contouring effects. However, objective data regarding the efficacy, safety, and clinical changes associated with the use of this device in actual clinical settings are not yet sufficiently accumulated.

This study aims to evaluate the clinical outcomes of mid- and lower-face lifting and contouring treatments using the NeoSculpt monopolar RF device through a retrospective pre-post comparative analysis utilizing existing clinical records.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• South Korea
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, South Korea, 13620
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study were conducted on patients who have visited Beautism Clear Skin Dermatology Clinic, received at least three sessions of Neosculpt treatment consistently, and are willing to participate in the research.

Description

Inclusion Criteria:

• Adult patients who have undergone mid- and lower-face lifting and contouring treatments using NeoSculpt RF
• Cases where pre- and post-treatment evaluation data are available after completing 3 sessions

Exclusion Criteria:

• Missing key evaluation data
• Cases where follow-up observations were not conducted after treatment

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

20 patients; This study is an observational, retrospective cohort study. Considering the number of patients available at a single institution and the feasibility of the study, a total of 20 participants were selected. This is considered the minimum number of subjects required to perform the pre-post comparative analysis planned in this study and to assess the clinical trends and safety of mid- and lower-face lifting and contouring treatments. In this study, personally identifiable information (such as name, resident registration number, etc.) will not be collected, and research data will be anonymized and analyzed using a study ID number. All data will be managed by the principal investigator, and use for purposes other than the research is restricted.

Device: NeoSculpt; This is a retrospective observational study analyzing existing medical records of patients who received NeoSculpt monopolar radiofrequency treatment as part of routine clinical care at a private dermatology clinic. The investigator did not assign or administer any intervention as part of this study. All clinical photographs, 3D photographic assessments, and ultrasound measurements were obtained during routine clinical visits prior to study initiation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinician-Assessed Improvement in Standardized Clinical Photographs	Two blinded dermatologists independently evaluate standardized clinical photographs taken before and after treatment. Improvement is rated on a 5-point scale (0 = no improvement, 1 = minimal improvement [1-25%], 2 = moderate improvement [26-50%], 3 = marked improvement [51-75%], 4 = excellent improvement [>75%]). Higher scores indicate greater improvement.	baseline, 1month, 2month, 3month, 6month
Change in Mid- and Lower-Face Volume Measured by 3D Photographic System	Facial volume in the mid-cheek, jawline, and nasolabial fold regions is measured using a 3D photographic system. Change from baseline is reported in cubic millimeters (mm³).	Baseline, Month 1, Month 2, Month 3, Month 6
Change in Skin Layer Collagen Thickness Measured by Ultrasound	Collagen thickness of the dermal layer is measured using high-frequency ultrasound imaging. Change from baseline is reported in millimeters (mm).	Baseline, Month 1, Month 2, Month 3, Month 6
Change in SMAS-Adjacent Adipose Tissue Thickness Measured by Ultrasound	Thickness of adipose tissue adjacent to the superficial musculoaponeurotic system (SMAS) is measured using high-frequency ultrasound imaging. Change from baseline is reported in millimeters (mm).	Baseline, Month 1, Month 2, Month 3, Month 6
Investigator Global Assessment (IGA) Score for Overall Facial Improvement	Three independent, blinded dermatologists evaluate overall facial improvement using the Investigator Global Assessment (IGA) scale. Scores range from 0 to 4 (0 = no improvement, 1 = minimal improvement [1-25%], 2 = moderate improvement [26-50%], 3 = marked improvement [51-75%], 4 = excellent improvement [>75%]). Higher scores indicate greater improvement. The mean score across three evaluators is reported.	Baseline, Month 1, Month 2, Month 3, Month 6
Incidence of Treatment-Emergent Adverse Events	Description: The number and percentage of participants experiencing adverse events following treatment, including but not limited to erythema, edema, blistering, and burns. Adverse events are recorded at each follow-up visit and categorized by type and severity.; Unit of Measure: Number of participants with adverse events	baseline, 1month, 2month, 3month, 6month
Duration and Resolution of Adverse Events	Description: For participants who experience adverse events, the duration (in days) from onset to resolution is recorded. Clinical course and any management performed are documented at each follow-up visit. Unit of Measure: Days	Month 1, Month 2, Month 3, Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-Reported Pain Score During Treatment	Patients rate procedural pain using a numeric rating scale from 0 to 10 (0 = no pain, 10 = worst imaginable pain). Higher scores indicate greater pain intensity.	Month 1, Month 2, Month 3
Patient-Reported Overall Satisfaction Score	Patients rate overall satisfaction with treatment outcome using a numeric rating scale from 0 to 10 (0 = completely dissatisfied, 10 = completely satisfied). Higher scores indicate greater satisfaction.	Month 1, Month 2, Month 3, Month 6

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: April 28, 2026
• First Submitted That Met QC Criteria: May 12, 2026
• First Posted (Actual): May 15, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Radiofrequency; lifting; rejuvenation; monopolar
• Other Study ID Numbers: NeoSculpt_SNUBH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No