Lifting EfficacyNCT07471399
Safety and Efficacy Assessment for the Temporary Facial Skin Tightening Improvement Effect Using the Monopolar Radiofrequency Device
A study testing Test arm in people with Lifting Efficacy, run by CLASSYS Inc. at 1 site in South Korea.
Trial summary
The purpose of this clinical trial is to demonstrate the temporary improvement in skin elasticity and to evaluate the safety of the investigational medical device that uses radiofrequency current when applied to the face (both cheeks), compared with the control device. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lifting Efficacy
- What is being tested?
- Test arm
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Feb 2026to 16 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants who are at least 19 years old and under 65 years of age as of the date of written informed consent.
- Participants whose average Cutometer R7 value for both checks is ≤0.6.
- Participants who consent to photographic documentation for verification of skin type(Fitzpatrick skin scale) and evaluation of treatment efficacy.
- Participants who agree to refrain from receiving any procedures or therapies that could influence skin elasticity improvement throughout the study period.
- Participants who agree to employ medically acceptable contraception for up to 4 weeks following the end of the study
- Participants who have adequately understood the objectives and procedures of the clinical trial, voluntarily consent in writing to participate, and are able to complete the study as required.
Who cannot join
- Participants who have any medical or dermatologic condition at the investigational medical device application area that may influence the conduct or results of the study.
- Participants who have scars or open lesions at the investigational medical device application area that may influence the conduct or results of the study.
- Participants who have metal stents or implants at the investigational medical device application area.
- Participants with severe solar elastosis.
- Participants judged by the investigator to have excessive facial subcutaneous fat requiring surgical intervention.
- Participants with a history of anaphylaxis or severe complex allergic reactions.
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- Participants with a history of or predisposition to hypertrophic scars or keloid formation.
- Participants with a history of adverse reactions to EMLA cream or local anesthetics (However, this criterion does not apply to participants who will not use anesthetics such as EMLA cream).
- Participants who have clinically significant disorders in the cardiovascular, gastrointestinal, respiratory, endocrine, or central nervous system that are not controlled by medication, or who have a history of or are currently receiving treatment for psychiatric disorders that may significantly affect this study.
- Participants with active herpes virus infection or autoimmune disease.
- Participants currently diagnosed with diabetes mellitus or epilepsy.
- Participants taking more than 100 mg of aspirin or aspirin-containing medication per day.
- Participants with bleeding disorders or blood coagulation-related diseases, such as thrombosis.
- Participants who have received Botox or filler injections at the investigational medical device application area* within 24 weeks prior to screening (*Investigational medical device application area: For participants undergoing facial (both cheeks) treatment - Mid-face (eyes to upper lip), Lower-face (lower lip to chin)) (However, if Botox or fillers were injected into the face but not within the application area, at least 12 weeks must have elapsed since the procedure).
- Participants who have undergone laser or light therapy at the investigational medical device application area within 24 weeks prior to screening.
- Participants who have undergone surgical or non-surgical treatments, such as deep chemical peels or liposuction, at the investigational medical device application area within 24 weeks prior to screening.
- Participants who have used topical agents (steroids, retinoids; limited to medicinal products, excluding cosmetics) at the investigational medical device application area within 4 weeks prior to screening, or who plan to continue use during the study.
- Participants who have smoked 100 or more cigarettes in their lifetime (However, those who have abstained from smoking for 24 weeks prior to screening are eligible for enrollment).
- Participants who are currently participating in another interventional clinical trial within 4 weeks prior to screening, or who plan to participate in another interventional clinical trial during this study.
- Pregnant or lactating women.
- Participants who are otherwise deemed unsuitable for participation in this study by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Safety and Efficacy Assessment for the Temporary Facial(Both Cheeks) Skin Tightening Improvement Effect Using the Monopolar Radiofrequency Device: Prospective, Single Center, Compared, Randomized, Evaluator-Blinded, Superiority, Pivotal Clinical Trial
The purpose of this clinical trial is to demonstrate the temporary improvement in skin elasticity and to evaluate the safety of the investigational medical device that uses radiofrequency current when applied to the face (both cheeks), compared with the control device.
Read the detailed description
This is a prospective, single-center, comparative, randomized, evaluator-blinded, superiority, confirmatory clinical trial designed to demonstrate the temporary improvement in skin elasticity and to evaluate the safety of an investigational medical device using radiofrequency current when applied to the face (both cheeks), compared with a control device.
- Conditions
- Lifting Efficacy
- Being tested
- Test arm, Control arm
- Keywords
- monopolar radiofrequency, facial skin tightening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test armDevice
Participants receive treatment with the investigational device VOLNEWMER applied to both cheeks.
Control armDevice
Participants receive treatment using the device in training mode that does not deliver radiofrequency energy.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Device arm | Experimental | Participants will receive treatment with the investigational radiofrequency medical device (VOLNEWMER) applied to both cheeks according to the study protocol. Receives: Device: Control arm |
| Control arm | Sham comparator | Subjects assigned to this arm will receive treatment with a sham device applied to both cheeks. The sham device is identical in appearance and operation to the investigational device but does not deliver radiofrequency energy. Receives: Device: Test arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cutometer R7 values
Change from baseline in Cutometer R7 value at Week 12 following treatment with the investigational medical device, as assessed by an independent evaluator.
Measured: 12 weeks
Secondary outcomes (4)
Change in Cutometer R7 values
Change from baseline in Cutometer R7 value at 8 weeks after application of the investigational medical device, as assessed by an independent evaluator.
Measured: 8 weeks
Percentage change from baseline in Cutometer R7 value
Percent change from baseline in Cutometer R7 value at Weeks 8 and 12 after application of the investigational medical device, as assessed by an independent evaluator.
Measured: week 8 and week 12
Global Aesthetic Improvement Scale (GAIS)
Global Aesthetic Improvement Scale(GAIS) scores at Weeks 4, 8, and 12 after application of the investigational medical device, as assessed by the investigator.
Measured: 4 weeks, 8 weeks, and 12 weeks
Global Aesthetic Improvement Scale(GAIS) assessment
Global Aesthetic Improvement Scale(GAIS) scores assessed by participants at 4, 8, and 12 weeks following treatment with the investigational medical device.
Measured: 4, 8, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start23 Feb 2026
- Primary completion16 Mar 2027 (estimated)
- Study completion16 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lifting EfficacyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- pivotal medical device clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CLASSYS Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chung-Ang University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07471399
- Sponsor's protocol ID
- VM-02
- Status last verified
- Jun 2026
- First submitted
- 10 Mar 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
el-Domyati M, el-Ammawi TS, Medhat W, Moawad O, Brennan D, Mahoney MG, Uitto J. Radiofrequency facial rejuvenation: evidence-based effect. J Am Acad Dermatol. 2011 Mar;64(3):524-35. doi: 10.1016/j.jaad.2010.06.045.
PubMed 21315951
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Assessment for the Temporary Facial(Both Cheeks) Skin Tightening Improvement Effect Using the Monopolar Radiofrequency Device: Prospective, Single Center, Compared, Randomized, Evaluator-Blinded, Superiority, Pivotal Clinical Trial
- ClinicalTrials.gov ID
- NCT07471399
- Acronym / sponsor ID
- VM-02
- Conditions
- Lifting Efficacy
- Keywords
- monopolar radiofrequency, facial skin tightening
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- CLASSYS Inc.Industry (pharma, biotech, devices)
- Collaborators
- Chung-Ang University Hospital
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- 16 Mar 2027 (estimated)
- Study completion
- 16 Mar 2027 (estimated)
- First posted
- 13 Mar 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 purpose of this clinical trial is to demonstrate the temporary improvement in skin elasticity and to evaluate the safety of the investigational medical device that uses radiofrequency current when applied to the face (both cheeks), compared with the control device.
Detailed description
This is a prospective, single-center, comparative, randomized, evaluator-blinded, superiority, confirmatory clinical trial designed to demonstrate the temporary improvement in skin elasticity and to evaluate the safety of an investigational medical device using radiofrequency current when applied to the face (both cheeks), compared with a control device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- pivotal medical device clinical trial
| Arm | Type | Receives |
|---|---|---|
| Investigational Device arm | Experimental | Device: Control armParticipants will receive treatment with the investigational radiofrequency medical device (VOLNEWMER) applied to both cheeks according to the study protocol. |
| Control arm | Sham comparator | Device: Test armSubjects assigned to this arm will receive treatment with a sham device applied to both cheeks. The sham device is identical in appearance and operation to the investigational device but does not deliver radiofrequency energy. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants who are at least 19 years old and under 65 years of age as of the date of written informed consent.
- Participants whose average Cutometer R7 value for both checks is ≤0.6.
- Participants who consent to photographic documentation for verification of skin type(Fitzpatrick skin scale) and evaluation of treatment efficacy.
- Participants who agree to refrain from receiving any procedures or therapies that could influence skin elasticity improvement throughout the study period.
- Participants who agree to employ medically acceptable contraception for up to 4 weeks following the end of the study
Key exclusion criteria (21 listed)
- Participants who have any medical or dermatologic condition at the investigational medical device application area that may influence the conduct or results of the study.
- Participants who have scars or open lesions at the investigational medical device application area that may influence the conduct or results of the study.
- Participants who have metal stents or implants at the investigational medical device application area.
- Participants with severe solar elastosis.
- Participants judged by the investigator to have excessive facial subcutaneous fat requiring surgical intervention.
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 |
|---|---|---|
| Test armParticipants receive treatment with the investigational device VOLNEWMER applied to both cheeks. | Device | Control arm |
| Control armParticipants receive treatment using the device in training mode that does not deliver radiofrequency energy. | Device | Investigational Device arm |
Primary outcome
Change in Cutometer R7 values
Time frame: 12 weeks
Change from baseline in Cutometer R7 value at Week 12 following treatment with the investigational medical device, as assessed by an independent evaluator.
4 secondary outcomes
Change in Cutometer R7 values
Time frame: 8 weeks
Percentage change from baseline in Cutometer R7 value
Time frame: week 8 and week 12
Global Aesthetic Improvement Scale (GAIS)
Time frame: 4 weeks, 8 weeks, and 12 weeks
Global Aesthetic Improvement Scale(GAIS) assessment
Time frame: 4, 8, and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Results publication: PubMed 21315951el-Domyati M, el-Ammawi TS, Medhat W, Moawad O, Brennan D, Mahoney MG, Uitto J. Radiofrequency facial rejuvenation: evidence-based effect. J Am Acad Dermatol. 2011 Mar;64(3):524-35. doi: 10.1016/j.jaad.2010.06.045.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test arm in people with Lifting Efficacy, run by CLASSYS Inc. 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 6 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 25 Jun 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hanyong Ghang (82-2-2094-2116, hy.ghang@classys.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cutometer R7 values (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07471399, which also lists 1 linked publication.
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 25 Jun 2026.