NCT06441799

Study on the Safety, Efficacy of Home RF Cosmetic Instrument in the Treatment of Facial or Periorbital Wrinkles

A Prospective, Randomized, Rate-blind, Multicenter, Optimity-designed Clinical Trial Evaluating the Safety and Efficacy of RFskin Therapy Devices for the Reduction of Skin Wrinkles

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 224 (actual)
• Sponsor: Glomed(HN)Co.Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a multicenter trial with randomized control and evaluator blind method, which meets the screening criteria total of 224 subjects were enrolled and randomly divided into control group and experiment according to 1:1 ratio Group), the subjects in the control group used medical ultrasonic coupler, and the subjects in the test group used test instruments Combined with medical ultrasonic coupler, use 5 days per week according to the prescribed use method (duration:Use the whole face for 10 minutes, use twice a day, a total of 20 minutes), continuous use 12Week. The changes of relevant clinical indicators and laboratory instrument measurements were evaluated. Objective : To evaluate the efficacy of radiofRF in reducing skin wrinkles and treating loose skin after 12 weeks of use of the test product Effectiveness and safety of relaxation and firming of skin tissue. The subjects were adults aged 18 years and above, regardless of gender, and had obvious wrinkles on the skin around the face and eyes (according to the selection Standard confirmation).

Detailed description

The purpose of the clinical trial was to see if home radiofrequency beauty devices were effective in treating adults for reducing skin wrinkles. It will also learn about the safety of home RF beauty devices. The main questions it aims to answer are: 1. Reduction of facial or periocular wrinkles based on Fitzpatrick score (12 weeks); 2. Possible adverse reactions and satisfaction survey during the use of subjects; The researchers will compare the radiofrequency beauty device group with the control group (only medical ultrasonic coupling) to verify whether the home radiofrequency beauty device is effective in reducing skin wrinkles. Participants will: Receive home treatment according to the experimental group and continue to use it for 12 weeks. At the 6th and 12th week, they will visit the medical institution for questionnaire survey and skin test. Keep a diary of their symptoms and the number of times they use radiofrequency beauty device or medical ultrasonic coupling.

Conditions

• Skin Wrinkles

Interventions

Type	Name	Description
DEVICE	Home radiofrequency skin treatment instrument	Subjects in the experimental group were treated with the test instrument combined with medical ultrasonic coupler for 5 days a week according to the prescribed use method (duration of use: 10 minutes for the whole face, continuous use twice a day, a total of 20 minutes) for 12 weeks. To evaluate the reduction of wrinkles before and after treatment and the changes of laboratory instruments.
OTHER	Ultrasonic coupler for medical purposes	In control group, medical ultrasonic coupler was evenly applied on face and orbit for 5 days a week (duration: 20 minutes) for 12 consecutive days Week. To evaluate the reduction of wrinkles and the change of laboratory instruments before and after use.

Timeline

• Start date: 2023-04-17
• Primary completion: 2023-08-29
• Completion: 2023-08-29
• First posted: 2024-06-04
• Last updated: 2024-08-07

Locations

1 site across 1 country: China