Temporary facial skin tightening with monopolar radiofrequency
Official title: Safety and Efficacy Assessment for the Temporary Facial(Both Cheeks) Skin Tightening Improvement Effect Using the Monopolar Radiofrequency Device: Prospective, Single Center, Compared, Randomized, Evaluator-Blinded, Superiority, Pivotal Clinical Trial
Run by CLASSYS Inc. · NCT07471399 · Data updated 2026-11-12
This trial will test whether a monopolar radiofrequency device can temporarily tighten the skin on both cheeks and is safe for adults with reduced skin elasticity.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 19 Years to 65 Years |
| Sex | All |
| Enrollment | 96 (estimated) |
| Sponsor | CLASSYS Inc. Industry-sponsored |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | February 23, 2026 |
| Main results expected | March 16, 2027 |
| Study ends | March 16, 2027 |
| Registry record updated | June 25, 2026 |
| Trial ID | NCT07471399 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 19–64 with reduced cheek skin elasticity (Cutometer R7 ≤ 0.6) who can attend a single-center site in Seoul, consent to photos, and agree to avoid other skin treatments during the study.
✕Probably not a fit
People with active dermatologic or medical conditions at the application site, those outside the eligible age or elasticity range, or those receiving other treatments that affect skin elasticity are unlikely to benefit from this device in this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, single-center, randomized, evaluator-blinded, superiority, confirmatory comparison of an investigational monopolar radiofrequency device versus a control device applied to both cheeks. Participants are adults aged 19–64 with reduced skin elasticity measured by Cutometer R7 and will be photographed for Fitzpatrick skin typing and efficacy documentation. The primary outcome is temporary improvement in skin elasticity with safety monitoring for device-related adverse events. Participants agree to avoid other procedures that could affect skin elasticity during the study and to use contraception for a short period after completion.
Why it matters
Potential benefit: If successful, the device could offer a non-surgical way to achieve short-term improvement in facial skin tightness and appearance.
How similar studies have gone: Previous studies of monopolar and other radiofrequency devices have reported short-term improvements in skin tightening with generally favorable safety profiles, though results and durability vary.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Classys Inc
Seoul, South Korea Recruiting
Study contacts
- Study coordinator: Hanyong Ghang
- Email: hy.ghang@classys.com
- Phone: 82-2-2094-2116
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.