Study on the Safety, Efficacy of Home RF Cosmetic Instrument in the Treatment of Facial or Periorbital Wrinkles（F-MFR300-RD-003）
NCT Number: NCT06565884
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Skin Wrinkles
Interventions: DEVICE: Home radiofrequency skin treatment instrument|OTHER: Ultrasonic coupler for medical purposes
Sponsor: Flossom (GD) Beauty Technology Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 224
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-03-28
Completion Date: 2023-09-11
Locations: Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, 510000, China

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).

Primary Outcome Measures: Wrinkle reduction efficiency based on Fitzpatrick score, After 12 weeks of treatment, wrinkles were more severe on a 0-9 scale (Fitzpatrick scale) Percentage of subjects with at least one grade (1 point) reduction at baseline., 12th week
Secondary Outcome Measures: Wrinkle reduction efficiency based on Fitzpatrick score, After 6 weeks of treatment, wrinkles were more severe on a 0-9 scale (Fitzpatrick scale) Percentage of subjects with at least one grade (1 point) reduction at baseline., 6th week|R2 values measured by the Cutometer dual MPA580, The R2 values of the two groups were compared after 6 weeks /12 weeks after using the RF instrument., 6th week\12th week|F4 values measured by the Cutometer dual MPA580, The F4 values of the two groups were compared after 6 weeks /12 weeks after using the RF instrument., 6th week\12th week|PRIMOS-CR measures the length of skin wrinkles, PRIMOS-CR measured crow's feet and compared the number of wrinkles between the two groups Quantity, 6th week\12th week|PRIMOS-CR measures the length and number of skin wrinkles, PRIMOS-CR measured under-eye lines and compared the number of wrinkles between the two groups Quantity, 6th week\12th week|PRIMOS-CR measures the length and number of skin wrinkles, PRIMOS-CR measured crow's feet and compared the number of wrinkles between the two groups length, 6th week\12th week|PRIMOS-CR measures the length and number of skin wrinkles, PRIMOS-CR measured under-eye lines and compared the number of wrinkles between the two groups length, 6th week\12th week|Lower face sag evaluation, According to the researchers' Skin Aging Atlas (R.Busin, F.folament), skin aging Tu Volume 2 Asian Edition). Translated by Qiu Huixia et al. \[M\]. Paris: MED 'com, 2010.) " To assess the severity of the subject's lower bilateral sagging., 6th week\12th week|Subject satisfaction evaluation, The participants received a questionnaire at the last visit, which mainly included the skin improvement effect of the product And the satisfaction degree of ease of operation, 6th week\12th week