CompletedNot Applicable

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

South Korea20 participantsStarted 2025-01-01

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Clinician-Assessed Improvement in Standardized Clinical Photographs

Timeframe: baseline, 1month, 2month, 3month, 6month

Change in Mid- and Lower-Face Volume Measured by 3D Photographic System

Timeframe: Baseline, Month 1, Month 2, Month 3, Month 6

Change in Skin Layer Collagen Thickness Measured by Ultrasound

Timeframe: Baseline, Month 1, Month 2, Month 3, Month 6

Change in SMAS-Adjacent Adipose Tissue Thickness Measured by Ultrasound

Timeframe: Baseline, Month 1, Month 2, Month 3, Month 6

Investigator Global Assessment (IGA) Score for Overall Facial Improvement

Timeframe: Baseline, Month 1, Month 2, Month 3, Month 6

Incidence of Treatment-Emergent Adverse Events

Timeframe: baseline, 1month, 2month, 3month, 6month

Duration and Resolution of Adverse Events

Timeframe: Month 1, Month 2, Month 3, Month 6

Trial details

NCT IDNCT07590843

SponsorSeoul National University Bundang Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Rejuvenation trials

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Clinician-Assessed Improvement in Standardized Clinical Photographs

Timeframe: baseline, 1month, 2month, 3month, 6month

Change in Mid- and Lower-Face Volume Measured by 3D Photographic System

Timeframe: Baseline, Month 1, Month 2, Month 3, Month 6

Change in Skin Layer Collagen Thickness Measured by Ultrasound

Timeframe: Baseline, Month 1, Month 2, Month 3, Month 6

Change in SMAS-Adjacent Adipose Tissue Thickness Measured by Ultrasound

Timeframe: Baseline, Month 1, Month 2, Month 3, Month 6

Investigator Global Assessment (IGA) Score for Overall Facial Improvement

Timeframe: Baseline, Month 1, Month 2, Month 3, Month 6

Incidence of Treatment-Emergent Adverse Events

Timeframe: baseline, 1month, 2month, 3month, 6month

Duration and Resolution of Adverse Events

Timeframe: Month 1, Month 2, Month 3, Month 6