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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).
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home radiofrequency skin treatment instrument | Experimental | Radiofrequency skin therapy instrument with medical ultrasound coupler is used for 20 minutes a day, 5 days a week |
|
| Medical ultrasound coupler | Placebo Comparator | Medical ultrasound coupler is applied to the face for 20 minutes a day, 5 days a week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home radiofrequency skin treatment instrument | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wei Lai, Doctor | Third Affiliated Hospital, Sun Yat-Sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510000 | China |
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The method of randomized control and evaluator blindness is suitable for screening A total of 224 subjects were enrolled and randomly divided into control group and experiment according to 1:1 ratio Group)
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Three doctors set up a blind evaluation group to evaluate the photos of the subjects before and after receiving the device treatment
|
| Ultrasonic coupler for medical purposes | Other | 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. |
|
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 crow's feet wrinkles | PRIMOS-CR measured crow's feet and compared the length of wrinkles between the two groups Quantity | 6th week\12th week |
| PRIMOS-CR measures the length of under-eye lines wrinkles | PRIMOS-CR measured under-eye lines and compared the length of wrinkles between the two groups Quantity | 6th week\12th week |
| PRIMOS-CR measures the number of crow's feet 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 number of under-eye lines 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, skin aging Type 2 Asian Edition , 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 |