Temporary facial skin tightening with monopolar radiofrequency
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 19 Years to 65 Years |
| Sex | All |
| Sponsor | CLASSYS Inc. Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT07471399 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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
Where this trial is running
Seoul
- Classys Inc — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Jihye Min
- Email: mins0131@classys.com
- Phone: 82-2-6313-2242
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.