RejuvenationNCT07590843
Efficacy and Safety of a Novel Monopolar Radiofrequency Device for Mid and Lower Face Rejuvenation
An observational study of Rejuvenation and Lifting Efficacy, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Rejuvenation, Lifting Efficacy, Medical Devices
- What is being tested?
- NeoSculpt
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Missing key evaluation data
- Cases where follow-up observations were not conducted after treatment
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
About this study
Official title: 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.
Read the 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.
- Conditions
- Rejuvenation, Lifting Efficacy, Medical Devices
- Being tested
- NeoSculpt
- Keywords
- Radiofrequency, monopolar, rejuvenation, lifting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeoSculptDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: NeoSculpt |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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
Measured: Month 1, Month 2, Month 3, Month 6
Secondary outcomes (2)
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.
Measured: 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.
Measured: Month 1, Month 2, Month 3, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start1 Jan 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RejuvenationStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Ri Kim, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07590843
- Sponsor's protocol ID
- NeoSculpt_SNUBH
- Status last verified
- Apr 2026
- First submitted
- 28 Apr 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a Novel Monopolar Radiofrequency Device for Mid and Lower Face Rejuvenation: A Retrospective Pre-Post Comparative Study
- ClinicalTrials.gov ID
- NCT07590843
- Acronym / sponsor ID
- NeoSculpt_SNUBH
- Conditions
- Rejuvenation, Lifting Efficacy, Medical Devices
- Keywords
- Radiofrequency, monopolar, rejuvenation, lifting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 20 patients | – | Device: NeoSculptThis 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Missing key evaluation data
- Cases where follow-up observations were not conducted after treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeoSculptThis 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. | Device | 20 patients |
Primary outcome
Clinician-Assessed Improvement in Standardized Clinical Photographs
Time frame: baseline, 1month, 2month, 3month, 6month
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.
Change in Mid- and Lower-Face Volume Measured by 3D Photographic System
Time frame: Baseline, Month 1, Month 2, Month 3, Month 6
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).
Change in Skin Layer Collagen Thickness Measured by Ultrasound
Time frame: Baseline, Month 1, Month 2, Month 3, Month 6
Collagen thickness of the dermal layer is measured using high-frequency ultrasound imaging. Change from baseline is reported in millimeters (mm).
Change in SMAS-Adjacent Adipose Tissue Thickness Measured by Ultrasound
Time frame: Baseline, Month 1, Month 2, Month 3, Month 6
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).
Investigator Global Assessment (IGA) Score for Overall Facial Improvement
Time frame: Baseline, Month 1, Month 2, Month 3, Month 6
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.
Incidence of Treatment-Emergent Adverse Events
Time frame: baseline, 1month, 2month, 3month, 6month
* 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
Duration and Resolution of Adverse Events
Time frame: Month 1, Month 2, Month 3, Month 6
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
2 secondary outcomes
Patient-Reported Pain Score During Treatment
Time frame: Month 1, Month 2, Month 3
Patient-Reported Overall Satisfaction Score
Time frame: Month 1, Month 2, Month 3, Month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rejuvenation and Lifting Efficacy, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician-Assessed Improvement in Standardized Clinical Photographs (time frame: baseline, 1month, 2month, 3month, 6month). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.