Safety and Efficacy Evaluation of the Monopolar Radiofrequency Device for the Improvement of Facial Wrinkles

Launched by CLASSYS INC. · Oct 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the monopolar radiofrequency device, which is designed to improve the appearance of facial wrinkles, especially around the eyes and mouth. The goal is to see if this device is safe and effective compared to a well-known treatment called the Thermage CPT System. Participants will receive one treatment session with either the new device or the control device and will be monitored for three months to assess how much their wrinkles improve and whether there are any side effects.

To participate, individuals need to be between 18 and 65 years old and have a specific level of facial wrinkles as measured by a scale. However, certain conditions may exclude someone from joining, such as having skin diseases, recent cosmetic treatments, or certain medical devices like pacemakers. If you decide to participate, you’ll be contributing to important research that could help improve anti-aging treatments for everyone!

Gender

ALL

Eligibility 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.