Skin aging
Conditions
Interventions
Experimental Group:Zone-specific rapid-slow pulse combined treatment regimen (applied to one randomized facial hemiface)
Control Group:Fixed-pulse full-face sweeping + vector line enhancement + local anchoring regimen (applied to the contralateral facial hemiface)
Sponsors
Chengdu Second People's Hospital
Eligibility
Sex/Gender
All
Age
30 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Aged 30-50 years, regardless of gender; 2.Mild to moderate facial skin laxity, with a Facial Laxity Rating Scale (FLR) score of 2-6 in the mid-face or lower face; 3.Participants voluntarily agree to take part in the study, comply with the investigator's schedule for hospital visits for treatment and examinations, and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1.History of severe skin allergies, and the subject is currently in the active phase of skin allergy; 2.Excessive skin exposure to sunlight within the past week (e.g., sunbathing or outdoor workers); 3.Received anti-wrinkle treatments in the treatment area within the past 6 months, such as botulinum toxin or fat injections; 4.Received monopolar radiofrequency or ultrasound therapy, or injections of facial fillers such as sodium hyaluronate, polylactic acid, or PCL in the treatment area within the past year; 5.Underwent a facelift or any facial plastic surgery in the treatment area within the past year; 6.Planning to undergo major facial surgery or other facial aesthetic treatments during the study period; 7.Received bipolar or multipolar radiofrequency treatments, ablative laser treatments within the past 6 months, or other light-based therapies such as facial photorejuvenation within the past 3 months; 8.Underwent or plans to undergo deep chemical peels during the trial period within the past month, or used or plans to use tretinoin or isotretinoin during the trial period within the past month; 9.Used or plans to use antihistamines, anti-inflammatory drugs, or immunosuppressants during the trial period within the past 2 months; 10.History of connective tissue disease or keloid tendency; 11.Suffering from autoimmune diseases (e.g., lupus erythematosus), psoriasis, vitiligo, or active herpes simplex; 12.Suffering from severe chronic systemic diseases (e.g., poorly controlled diabetes or hypertension) or severe mental illness; 13.History of severe cardiac, hepatic, or renal dysfunction or malignant tumors; 14.Presence of inflammatory reactions, significant scars, hemangiomas, severe acne, or other skin lesions in the treatment area that may affect trial result assessment; 15.Presence of cancerous or precancerous lesions in the treatment area, or history of radiation therapy in the area; 16.Systemic or localized infection; 17.History of bleeding disorders; 18.Implanted with a pacemaker, implantable cardioverter-defibrillator (ICD), or any other type of electronic implant; 19.Presence of metal implants beneath the treatment area, such as dental metal implants; 20.Severe obesity with a BMI > 30; 21.History of facial nerve paralysis; 22.Urine pregnancy test (free screening in this study) indicating pregnancy, lactation, or planning pregnancy during the study period; 23.Participation in or enrollment in other medical device or drug clinical trials within the past month; 24.Subjects deemed by the investigator to have poor compliance, perceptual impairments, or other reasons making them unsuitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Facial wrinkle improvement efficacy rate at day 90 post-treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in facial volume;Alterations in facial wrinkles and skin texture;Pain Score;Facial wrinkle improvement efficacy rate immediately after treatment;Facial wrinkle improvement efficacy rate at day 30 post-treatment;Facial wrinkle improvement efficacy rate at day 180 post-treatment;Simplicity of the treatment method;Total Energy;Total treatment time; | — |
Countries
China
Contacts
Public ContactWa Qingbiao
Chengdu Second People's Hospital
Outcome results
None listed