Skin AgingNCT06816069
Study on Safety and Efficacy of Monopolar Radio Frequency Device for Facial Skin Tightening
A study testing VOLNEWMER in people with Skin Aging, run by CLASSYS Inc. at 1 site in South Korea.
Trial summary
Objective: The goal of this clinical trial is to evaluate the safety and efficacy of the VOLNEWMER monopolar radiofrequency device developed by CLASSYS Inc. This study is a prospective, single-center, single-arm, pilot clinical trial. Research Questions: 1. Does the VOLNEWMER device improve skin elasticity? 2. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Aging
- What is being tested?
- VOLNEWMER
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Nov 2024to 1 Mar 2025
- 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
- Subjects who are aged 19 to under 65 at the time of consent.
- Subjects who seek improvement in facial skin elasticity (both cheeks).
- Subjects who agree not to undergo other procedures affecting skin elasticity during the study.
- Subjects who provide written consent and commit to full trial participation.
Who cannot join
- Subjects with conditions at the investigational device application site (e.g., scars, open wounds, metal stents, or implants, that could affect the trial)
- Subjects with inappropriate skin conditions or treatment history
- Subjects with allergies or predispositions
- Subjects using inappropriate medications that have the potential to increase the risk of bleeding or delay skin healing.
- Subjects with lifestyle or other unsuitable conditions (Smoking history, participation in another interventional clinical trial prior to screening, not agreeing to use medically acceptable contraception, pregnant or breastfeeding women)
- Subjects deemed inappropriate by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Stage Safety and Efficacy Assessment for the Temporary Facial(both Cheeks) Skin Tightening Improvement Effect Using the Monopolar Radiofrequency Device: Prospective, Open-label, Single Center, Single-arm, Pilot Clinical Trial
Objective:
The goal of this clinical trial is to evaluate the safety and efficacy of the VOLNEWMER monopolar radiofrequency device developed by CLASSYS Inc. This study is a prospective, single-center, single-arm, pilot clinical trial.
Read more
Research Questions:
- Does the VOLNEWMER device improve skin elasticity?
- Is the safety profile of the VOLNEWMER device acceptable?
Subject Procedures:
Subjects will:
- Receive a single treatment session using the VOLNEWMER device.
- Attend follow-up visits over a 12-week period to assess improvements in elasticity and safety.
The primary outcome is the improvement in skin elasticity of the face and cheeks, measured 12 weeks after treatment using the Cutometer R7. Secondary outcomes include the Global Aesthetic Improvement Scale (GAIS). Safety assessments involve monitoring treatment-emergent adverse events (TEAEs) associated with the application of the investigational medical device.
- Conditions
- Skin Aging
- Being tested
- VOLNEWMER
- Keywords
- VOLNEWMER, Monopolar radiofrequency device, MRF, Skin Tightening, Facial skin treatment, Skin Elasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VOLNEWMERDevice
Monopolar radiofrequency device
| Study group | Role | What they receive |
|---|---|---|
| VOLNEWMER | Experimental | Each subject will undergo a procedure using VOLNEWMER's F-Tip or V-tip electrode with either the Basic mode or Easy mode, depending on the treatment area. Receives: Device: VOLNEWMER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cutometer R7 values
The change in Cutometer R7 values measured on the cheeks at 12 weeks after the application of the investigational medical device compared to baseline will be evaluated.
Measured: baseline, 12 weeks
Secondary outcomes (3)
Change in Cutometer R7 values
The change in Cutometer R7 values measured on the cheeks at 8 weeks after the application of the investigational medical device compared to baseline will be evaluated.
Measured: baseline, 8 weeks
Global Aesthetic Improvement Scale (GAIS)
The Global Aesthetic Improvement Scale (GAIS) assessed by both the investigator and the subjects at 4, 8, and 12 weeks after the application of the investigational medical device will be evaluated.
- Minimum and Maximum Values: The GAIS ranges from -1 (worse) to +3 (excellent improvement).
- Outcome Interpretation: Higher scores indicate a better aesthetic outcome.
Measured: 4 weeks, 8 weeks, 12 weeks
Numeric Rating Scale (NRS) for Pain
The subject's pain level at the treatment site will be evaluated using the Numeric Rating Scale (NRS) at the baseline visit and at 4, 8, and 12 weeks after the application of the investigational medical device.
- Minimum and Maximum Values: The NRS ranges from 0 (no pain) to 10 (worst imaginable pain).
- Outcome Interpretation: Higher scores indicate worse pain.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start10 Nov 2024
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AgingStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CLASSYS Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06816069
- Sponsor's protocol ID
- VM-01
- Status last verified
- Feb 2025
- First submitted
- 4 Feb 2025
- Last updated
- 18 Feb 2025
- 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 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Stage Safety and Efficacy Assessment for the Temporary Facial(both Cheeks) Skin Tightening Improvement Effect Using the Monopolar Radiofrequency Device: Prospective, Open-label, Single Center, Single-arm, Pilot Clinical Trial
- ClinicalTrials.gov ID
- NCT06816069
- Acronym / sponsor ID
- VM-01
- Conditions
- Skin Aging
- Keywords
- VOLNEWMER, Monopolar radiofrequency device, MRF, Skin Tightening, Facial skin treatment, Skin Elasticity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- CLASSYS Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Nov 2024 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 10 Feb 2025 (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.
Objective:
The goal of this clinical trial is to evaluate the safety and efficacy of the VOLNEWMER monopolar radiofrequency device developed by CLASSYS Inc. This study is a prospective, single-center, single-arm, pilot clinical trial.
Research Questions:
- Does the VOLNEWMER device improve skin elasticity?
- Is the safety profile of the VOLNEWMER device acceptable?
Subject Procedures:
Subjects will:
- Receive a single treatment session using the VOLNEWMER device.
- Attend follow-up visits over a 12-week period to assess improvements in elasticity and safety.
The primary outcome is the improvement in skin elasticity of the face and cheeks, measured 12 weeks after treatment using the Cutometer R7. Secondary outcomes include the Global Aesthetic Improvement Scale (GAIS). Safety assessments involve monitoring treatment-emergent adverse events (TEAEs) associated with the application of the investigational medical device.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VOLNEWMER | Experimental | Device: VOLNEWMEREach subject will undergo a procedure using VOLNEWMER's F-Tip or V-tip electrode with either the Basic mode or Easy mode, depending on the treatment area. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects who are aged 19 to under 65 at the time of consent.
- Subjects who seek improvement in facial skin elasticity (both cheeks).
- Subjects who agree not to undergo other procedures affecting skin elasticity during the study.
- Subjects who provide written consent and commit to full trial participation.
Key exclusion criteria (6 listed)
- Subjects with conditions at the investigational device application site (e.g., scars, open wounds, metal stents, or implants, that could affect the trial)
- Subjects with inappropriate skin conditions or treatment history
- Subjects with allergies or predispositions
- Subjects using inappropriate medications that have the potential to increase the risk of bleeding or delay skin healing.
- Subjects with lifestyle or other unsuitable conditions (Smoking history, participation in another interventional clinical trial prior to screening, not agreeing to use medically acceptable contraception, pregnant or breastfeeding women)
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 |
|---|---|---|
| VOLNEWMERMonopolar radiofrequency device | Device | VOLNEWMER |
Primary outcome
Change in Cutometer R7 values
Time frame: baseline, 12 weeks
The change in Cutometer R7 values measured on the cheeks at 12 weeks after the application of the investigational medical device compared to baseline will be evaluated.
3 secondary outcomes
Change in Cutometer R7 values
Time frame: baseline, 8 weeks
Global Aesthetic Improvement Scale (GAIS)
Time frame: 4 weeks, 8 weeks, 12 weeks
Numeric Rating Scale (NRS) for Pain
Time frame: Baseline, 4 weeks, 8 weeks, 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 18 Feb 2025.
- 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?
A study testing VOLNEWMER in people with Skin Aging, 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 4 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 18 Feb 2025. 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?
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?
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?
Change in Cutometer R7 values (time frame: baseline, 12 weeks). 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 18 Feb 2025.