New device aims to tighten cheeks without surgery
NCT ID NCT07471399
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
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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
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About 96 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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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
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19 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Classys Inc
RECRUITINGSeoul, 06220, South Korea
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