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

NCT07590843 | Completed

• 1 other identifier: NeoSculpt_SNUBH
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rejuvenation; Lifting Efficacy; Medical Devices

Keywords

Radiofrequency; monopolar; rejuvenation; lifting

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (2)

• Patient-Reported Pain Score During Treatment

  Month 1, Month 2, Month 3

• Patient-Reported Overall Satisfaction Score

  Month 1, Month 2, Month 3, Month 6

Study Arms (1)

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

Interventions

NeoSculpt DEVICE

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.

20 patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 15, 2026
• Study Start: January 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)