Evaluation of a device for improving facial wrinkles
Safety and Efficacy Evaluation of the Monopolar Radiofrequency Device for the Improvement of the Facial Wrinkles, a Prospective, Multicenter, Evaluator Blinded, Randomized, Parallel-controlled, Non-inferior Clinical Trial
This study is testing a new device to see if it can safely reduce facial wrinkles better than a well-known treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 284 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | CLASSYS Inc. Industry-sponsored |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06657365 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety and effectiveness of a monopolar radiofrequency device developed by CLASSYS Inc. for treating facial and periorbital wrinkles. It is a multicenter, evaluator-blinded, randomized, parallel-controlled trial comparing the investigational device to the established Thermage CPT System. Participants will receive a single treatment session and will be monitored for three months to evaluate improvements in wrinkle appearance and safety outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with moderate facial and periorbital wrinkles.
Not a fit: Patients with skin diseases, metal implants, or certain medical conditions may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could provide a non-invasive option for patients seeking to reduce facial wrinkles.
How similar studies have performed: Previous studies have shown success with radiofrequency treatments for skin rejuvenation, indicating potential for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing
- Beijing Anzhen Hospital[北京安贞医院] — Beijing, China (Recruiting)
Study contacts
- Principal investigator: 文志 李 — Beijing Anzhen Hospital
- Study coordinator: Moonhee Lee
- Email: mhlee@classys.com
- Phone: +82 10-9913-5904
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.