Wrinkles
Conditions
Interventions
Experimental group:Use the radiofrequency device produced by Kunshan WE Medical Technology Co., LTD for treatment
Control Group:Use the radiofrequency device produced by Solta Medical, Inc for treatment
Sponsors
Plastic Surgery Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
30 Years to 60 Years
Inclusion criteria
Inclusion criteria: 30-60 years old, gender is not limited; Facial wrinkles FWCS score of 3-6 points; Fitzpatrick skin classification II ~ V type; The subjects voluntarily participated in this study, followed the researcher's arrangement to come to the hospital for treatment and examination, and signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1) Has a history of severe skin allergies and the subject is currently in an active period of skin allergies; 2) Skin exposure within the past week (such as sunbathing or outdoor work); 3) Within the past 6 months, the area to be treated has received skin anti wrinkle treatments such as botulinum toxin and fat injection; 4) Within the past year, the area to be treated has received treatment with monopolar radiofrequency or ultrasonic knife, or injected with facial fillers such as sodium hyaluronate, polylactic acid, or PCL; 5) Individuals who have undergone facial lifting surgery or other facial plastic surgery in the area to be treated within the past year; 6) Those who plan to undergo major facial surgery or other facial beauty treatments during the research period; 7) Received bipolar or multipole radiofrequency therapy, ablative laser therapy, or other phototherapy such as facial photon rejuvenation within the past 6 months; 8) Those who have undergone or plan to undergo deep chemical exfoliation during the trial period within the past month, or those who have used or plan to use tretinoin or isotretinoin treatment during the trial period within the past month; 9) Have used or plan to use antihistamines, anti-inflammatory and immunosuppressive drugs during the trial period in the past 2 months; 10) Individuals with connective tissue disease or scar constitution; 11) Individuals with autoimmune diseases (such as lupus erythematosus), psoriasis, vitiligo, or those in the active phase of herpes simplex; 12) Patients with serious systemic diseases (such as diabetes, hypertension, etc. that are still uncontrollable after treatment) and serious mental diseases; 13) Severe heart, liver, and kidney dysfunction (heart function: grade III or above; ALT and AST>3 times the upper limit of normal values; Subjects with blood creatinine levels greater than 15 times the upper limit of normal or a history of malignant tumors; 14) Skin lesions that affect the determination of test results, such as inflammatory reactions, significant scars, vascular tumors, and severe acne, are present in the area to be treated; 15) Patients with cancerous or precancerous lesions in the area to be treated, or those who have received radiation therapy locally; 16) Individuals with systemic or local infections; 17) Individuals with bleeding disorders; 18) Individuals equipped with implantable pacemakers, implantable heart rate defibrillators (ICDs), or any other type of implanted electronic devices; 19) For those with metal implants under the treatment area, such as dental metal implants; 20) Severely obese individuals with BMI>30; 21) History of facial nerve paralysis; 22) Women who are currently pregnant or breastfeeding, or have fertility plans during the study period; 23) Those who have participated or are currently participating in clinical trials of other medical devices or drugs within the past month; 24) Researchers evaluate subjects who are not suitable to participate in this clinical trial due to poor compliance or perceptual barriers, among other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective rate of improving facial wrinkles on the 90th day after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fitzpatrick wrinkle classifcation system;Physcian's Global Aesthethic Improvement Scale;Subject’s Global Aesthethic Improvement Scale;VISIA Test score;Pain score;Adverse event ; | — |
Countries
China
Contacts
Public ContactYan Yan
Plastic Surgery Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed