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New Wrinkle-Zapping device put to the test

NCT ID NCT06657365

Symptom relief Sponsor: CLASSYS Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new device that uses radiofrequency energy to tighten skin and reduce wrinkles on the face and around the eyes. 284 adults received one treatment session and were followed for 3 months. The goal was to see if the new device works as well as an existing device, with a focus on safety and wrinkle improvement.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
monopolar radiofrequency device (Volnewmer)
What this could lead to
If it works, this could offer a non-invasive option for reducing facial wrinkles with similar results to existing treatments.
What could go wrong
This is a completed trial, but results may not apply to all skin types or ages. The improvement is cosmetic and temporary, not a cure for aging.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

284 people

The number who actually took part.

Started

Sep 2024

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 18 to 65 years old（The date of signing the informed consent shall prevail）, gender is not limited. 2. Facial and periorbital wrinkle and elasticity Scale (FWES) Score ≥ 3 points. Both the facial and periorbital FWES should meet the criteria. 3. The subject fully understands the benefits and risks of this experiment, and is still willing to participate and sign the informed consent. Exclusion Criteria: 1. Individuals with skin diseases, scars, open wounds, or metal implants in the area where clinical trial medical devices will be applied. 2. Patients with implanted electrical devices (e.g., pacemakers, AICDs). 3. Those with a history of hypertrophic scars, keloids, or severe allergic reactions. 4. Individuals with excessive facial fat requiring surgical treatment. 5. Those with autoimmune diseases, acute viral herpes, or poorly controlled diabetes. 6. People with abnormal coagulation function or those taking anticoagulant medications (e.g., aspirin, warfarin) within 1 week of screening. 7. Individuals treated with fillers or botulinum toxin within the last 6 months or permanent fillers in the treatment area. 8. Those who have received skin treatments (e.g., deep exfoliation, lasers, light therapy) in the treatment area within 6 months. 9. Pregnant or lactating women, or women of childbearing potential not using medically accepted contraception. 10. Persons deemed inappropriate by the investigator to participate in this clinical trial.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anti aging Facial wrinkles Wrinkles Wrinkles and rhytides Wrinkles such as nasolabial folds

Contacts and locations

Locations

  • Beijing Anzhen Hospital[北京安贞医院]

    Beijing, China

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