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New device aims to tighten cheeks without surgery

NCT ID NCT07471399

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a device that uses radiofrequency energy to temporarily tighten the skin on both cheeks. About 96 adults aged 19-64 with loose skin will receive either the active device or a sham treatment. Researchers will measure skin elasticity changes at 8 and 12 weeks to see if the device works better than placebo.

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 successful, this could provide a non-invasive option for temporary skin tightening without surgery.
What could go wrong
This is an early-stage trial with a small sample size. The effect is temporary, and results may not apply to all skin types or ages.

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

About 96 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Mar 2027

An estimate. End dates often move.

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

19 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. Participants who are at least 19 years old and under 65 years of age as of the date of written informed consent. 2. Participants whose average Cutometer R7 value for both checks is ≤0.6. 3. Participants who consent to photographic documentation for verification of skin type(Fitzpatrick skin scale) and evaluation of treatment efficacy. 4. Participants who agree to refrain from receiving any procedures or therapies that could influence skin elasticity improvement throughout the study period. 5. Participants who agree to employ medically acceptable contraception for up to 4 weeks following the end of the study 6. 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. Exclusion Criteria: 1. 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. 2. Participants who have scars or open lesions at the investigational medical device application area that may influence the conduct or results of the study. 3. Participants who have metal stents or implants at the investigational medical device application area. 4. Participants with severe solar elastosis. 5. Participants judged by the investigator to have excessive facial subcutaneous fat requiring surgical intervention. 6. Participants with a history of anaphylaxis or severe complex allergic reactions. 7. Participants with a history of or predisposition to hypertrophic scars or keloid formation. 8. 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). 9. 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. 10. Participants with active herpes virus infection or autoimmune disease. 11. Participants currently diagnosed with diabetes mellitus or epilepsy. 12. Participants taking more than 100 mg of aspirin or aspirin-containing medication per day. 13. Participants with bleeding disorders or blood coagulation-related diseases, such as thrombosis. 14. 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). 15. Participants who have undergone laser or light therapy at the investigational medical device application area within 24 weeks prior to screening. 16. 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. 17. 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. 18. 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). 19. 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. 20. Pregnant or lactating women. 21. Participants who are otherwise deemed unsuitable for participation in this study by the investigator.

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As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Classys Inc

    RECRUITING

    Seoul, 06220, South Korea

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