Facial WrinklesNCT06657365
Safety and Efficacy Evaluation of the Monopolar Radiofrequency Device for the Improvement of Facial Wrinkles
A study testing Radiofrequency (RF) Treatment with Volnewmer and Radiofrequency (RF) Treatment with Thermage CPT in people with Facial Wrinkles and Anti-Aging, run by CLASSYS Inc. at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the safety and efficacy of the monopolar radiofrequency therapy device developed by CLASSYS Inc. for improving facial and periorbital wrinkles. This is a prospective, multicenter, evaluator-blinded, randomized, parallel-controlled, non-inferiority clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Facial Wrinkles, Anti-Aging, Wrinkles and Rhytides
- What is being tested?
- Radiofrequency (RF) Treatment with Volnewmer and Radiofrequency (RF) Treatment with Thermage CPT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 1 siteChina
- Study dates
- 29 Sep 2024to 3 Jul 2025
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 to 65 years old（The date of signing the informed consent shall prevail）, gender is not limited.
- Facial and periorbital wrinkle and elasticity Scale (FWES) Score ≥ 3 points. Both the facial and periorbital FWES should meet the criteria.
- The subject fully understands the benefits and risks of this experiment, and is still willing to participate and sign the informed consent.
Who cannot join
- Individuals with skin diseases, scars, open wounds, or metal implants in the area where clinical trial medical devices will be applied.
- Patients with implanted electrical devices (e.g., pacemakers, AICDs).
- Those with a history of hypertrophic scars, keloids, or severe allergic reactions.
- Individuals with excessive facial fat requiring surgical treatment.
- Those with autoimmune diseases, acute viral herpes, or poorly controlled diabetes.
- People with abnormal coagulation function or those taking anticoagulant medications (e.g., aspirin, warfarin) within 1 week of screening.
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- Individuals treated with fillers or botulinum toxin within the last 6 months or permanent fillers in the treatment area.
- Those who have received skin treatments (e.g., deep exfoliation, lasers, light therapy) in the treatment area within 6 months.
- Pregnant or lactating women, or women of childbearing potential not using medically accepted contraception.
- Persons deemed inappropriate by the investigator to participate in this clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy Evaluation of the Monopolar Radiofrequency Device for the Improvement of the Facial Wrinkles, a Prospective, Multicenter, Evaluator Blinded, Randomized, Parallel-controlled, Non-inferior Clinical Trial
The goal of this clinical trial is to evaluate the safety and efficacy of the monopolar radiofrequency therapy device developed by CLASSYS Inc. for improving facial and periorbital wrinkles. This is a prospective, multicenter, evaluator-blinded, randomized, parallel-controlled, non-inferiority clinical trial.
The main questions the study aims to answer are:
Read more
Does the monopolar radiofrequency device improve the appearance of facial and periorbital wrinkles? Is the safety profile of the monopolar radiofrequency device acceptable?
Researchers will compare the investigational device to the Thermage CPT System (Solta Medical Co., Ltd.) to see if the monopolar radiofrequency device is non-inferior in terms of wrinkle improvement.
Participants will:
Undergo a single treatment session with either the investigational device or the control device.
Be followed up for a period of 3 months to assess wrinkle improvement and safety outcomes.
The primary outcome will be the improvement in facial and periorbital wrinkles, measured by the Facial Wrinkle and Elasticity Scale (FWES), 3 months post-treatment. Secondary outcomes include the Global Aesthetic Improvement Scale (GAIS) and a Visual Analog Scale (VAS) for pain. Safety evaluations will include adverse event (AE) and serious adverse event (SAE) monitoring.
- Conditions
- Facial Wrinkles, Anti-Aging, Wrinkles and Rhytides, Wrinkles Such as Nasolabial Folds, Wrinkles
- Being tested
- Radiofrequency (RF) Treatment with Volnewmer, Radiofrequency (RF) Treatment with Thermage CPT
- Keywords
- VOLNEWMER, facial skin treatment, nasolabial folds, marionette line, MRF, facial wrinkles, wrinkles, monopolar radiofrequency device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency (RF) Treatment with VolnewmerDevice
Non-invasive radiofrequency-based skin tightening using the Volnewmer device.
Radiofrequency (RF) Treatment with Thermage CPTDevice
Non-invasive radiofrequency-based skin tightening using the Thermage CPT device.
| Study group | Role | What they receive |
|---|---|---|
| VOLNEWMER | Experimental | A non-invasive skin tightening treatment using the Volnewmer device. Receives: Device: Radiofrequency (RF) Treatment with Volnewmer |
| Thermage CPT | Active comparator | A non-invasive skin tightening treatment using the Thermage CPT device. Receives: Device: Radiofrequency (RF) Treatment with Thermage CPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
FWES
Facial wrinkle improvement was defined as reduction of FWES subgroup score≥1.
Measured: 3 months after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start29 Sep 2024
- Primary completion11 Jan 2025
- Study completion3 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial WrinklesStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- CLASSYS Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 文志 李, Principal investigator, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657365
- Sponsor's protocol ID
- CLSSPZLY
- Status last verified
- Sep 2025
- First submitted
- 23 Oct 2024
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Evaluation of the Monopolar Radiofrequency Device for the Improvement of the Facial Wrinkles, a Prospective, Multicenter, Evaluator Blinded, Randomized, Parallel-controlled, Non-inferior Clinical Trial
- ClinicalTrials.gov ID
- NCT06657365
- Acronym / sponsor ID
- CLSSPZLY
- Conditions
- Facial Wrinkles, Anti-Aging, Wrinkles and Rhytides, Wrinkles Such as Nasolabial Folds, Wrinkles
- Keywords
- VOLNEWMER, facial skin treatment, nasolabial folds, marionette line, MRF, facial wrinkles, wrinkles, monopolar radiofrequency device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- CLASSYS Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Sep 2024 (actual)
- Primary completion
- 11 Jan 2025 (actual)
- Study completion
- 3 Jul 2025 (actual)
- First posted
- 24 Oct 2024 (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 goal of this clinical trial is to evaluate the safety and efficacy of the monopolar radiofrequency therapy device developed by CLASSYS Inc. for improving facial and periorbital wrinkles. This is a prospective, multicenter, evaluator-blinded, randomized, parallel-controlled, non-inferiority clinical trial.
The main questions the study aims to answer are:
Does the monopolar radiofrequency device improve the appearance of facial and periorbital wrinkles? Is the safety profile of the monopolar radiofrequency device acceptable?
Researchers will compare the investigational device to the Thermage CPT System (Solta Medical Co., Ltd.) to see if the monopolar radiofrequency device is non-inferior in terms of wrinkle improvement.
Participants will:
Undergo a single treatment session with either the investigational device or the control device.
Be followed up for a period of 3 months to assess wrinkle improvement and safety outcomes.
The primary outcome will be the improvement in facial and periorbital wrinkles, measured by the Facial Wrinkle and Elasticity Scale (FWES), 3 months post-treatment. Secondary outcomes include the Global Aesthetic Improvement Scale (GAIS) and a Visual Analog Scale (VAS) for pain. Safety evaluations will include adverse event (AE) and serious adverse event (SAE) monitoring.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VOLNEWMER | Experimental | Device: Radiofrequency (RF) Treatment with VolnewmerA non-invasive skin tightening treatment using the Volnewmer device. |
| Thermage CPT | Active comparator | Device: Radiofrequency (RF) Treatment with Thermage CPTA non-invasive skin tightening treatment using the Thermage CPT device. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 to 65 years old（The date of signing the informed consent shall prevail）, gender is not limited.
- Facial and periorbital wrinkle and elasticity Scale (FWES) Score ≥ 3 points. Both the facial and periorbital FWES should meet the criteria.
- The subject fully understands the benefits and risks of this experiment, and is still willing to participate and sign the informed consent.
Key exclusion criteria (10 listed)
- Individuals with skin diseases, scars, open wounds, or metal implants in the area where clinical trial medical devices will be applied.
- Patients with implanted electrical devices (e.g., pacemakers, AICDs).
- Those with a history of hypertrophic scars, keloids, or severe allergic reactions.
- Individuals with excessive facial fat requiring surgical treatment.
- Those with autoimmune diseases, acute viral herpes, or poorly controlled diabetes.
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 |
|---|---|---|
| Radiofrequency (RF) Treatment with VolnewmerNon-invasive radiofrequency-based skin tightening using the Volnewmer device. | Device | VOLNEWMER |
| Radiofrequency (RF) Treatment with Thermage CPTNon-invasive radiofrequency-based skin tightening using the Thermage CPT device. | Device | Thermage CPT |
Primary outcome
FWES
Time frame: 3 months after the treatment
Facial wrinkle improvement was defined as reduction of FWES subgroup score≥1.
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 4 May 2026.
- 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. This study is not recruiting at the moment.
文志 李 principal investigator
Beijing Anzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency (RF) Treatment with Volnewmer and Radiofrequency (RF) Treatment with Thermage CPT in people with Facial Wrinkles and Anti-Aging, run by CLASSYS Inc. at 1 site in China.
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 3 inclusion and 10 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 4 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 China. 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?
FWES (time frame: 3 months after the treatment). 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 4 May 2026.