Facial skin wrinkles
Conditions
Interventions
Experimental Group:Subjects in the experimental group will receive treatment with the radiofrequency therapeutic apparatus produced by Sichuan Xingtai Pule Medical Technology Co., Ltd. for reducing fa
Control Group:Subjects in the control group will receive treatment with the radiofrequency therapeutic apparatus produced by Solta Medical, Inc. (Registration Certificate No.: National Medical Device
Sponsors
Xuanwu Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
25 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Aged >=25 and <=65 years, gender; (2) Having global aesthetic and mild to moderate facial skin wrinkles, with a facial Fitzpatrick Wrinkle Classification Scale (FWCS) score of 3–6; (3) Facial Fitzpatrick Skin Type ?–?; (4) The subject or their legal representative can understand the study purpose, demonstrate sufficient compliance with the study protocol, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) BMI > 30 kg/m², or planned lifestyle modifications or other interventions during the trial that may significantly affect body weight; (2) History of severe skin allergies or current active skin allergy; (3) History of anti-wrinkle treatments (e.g., botulinum toxin injection, fat injection) in the treatment area within 9 months prior to screening; (4) History of monopolar radiofrequency therapy, focused ultrasound therapy, facial filler treatments (e.g., sodium hyaluronate, polylactic acid, or PCL), facial lifting surgery, or other facial plastic surgeries with effects lasting >12 months in the treatment area within 12 months prior to screening; (5) History of bipolar/multipolar radiofrequency device treatment (including home-use radiofrequency devices) or ablative laser therapy within 6 months prior to screening, or other photoelectric therapies (e.g., facial photorejuvenation) within 3 months prior to screening; (6) History of deep chemical peeling within 1 month prior to screening or planned during the trial; (7) Topical use of tretinoin or isotretinoin within 1 month prior to screening or planned during the trial, or oral use of tretinoin or isotretinoin within 3 months prior to screening or planned during the trial; (8) Comorbidities including connective tissue diseases (e.g., lupus erythematosus), psoriasis, vitiligo, active herpes simplex, or scar diathesis; (9) Skin lesions in the treatment area that may affect trial outcome assessment, such as active inflammation, unhealed wounds, significant scars, hemangiomas, severe pigmentation, or tattoos; (10) Malignancy, precancerous lesions, or prior radiotherapy in the treatment area; (11) Implanted medical devices including pacemakers, implantable cardioverter-defibrillators (ICDs), automatic implantable cardioverter-defibrillators (AICDs), or other implanted electronic devices; (12) Unknown fillers or metal implants (e.g., dental metal implants) under the treatment area; (13) History of facial nerve paralysis; (14) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >= 1.5 × upper limit of normal (ULN); (15) Urea (BUN) or serum creatinine (Cr) >= 1.5 × ULN; (16) Pregnant or lactating women; (17) Participation in other medical device or drug clinical trials within 1 month prior to screening or currently enrolled; (18) Other conditions deemed unsuitable for trial participation by the investigator, such as poor compliance or perceptual impairment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective Rate of Global Facial Aesthetic Improvement at Week 12 After Treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Effective Rate of Global Facial Aesthetic Improvement at Week 4 and Week 24 After Treatment;Subject Self-Assessment of Global Aesthetic Effect at Week 4, Week 12, and Week 24 After Treatment;Subject Self-Assessment of Global Aesthetic Effect at Week 4, Week 12, and Week 24 After Treatment;Mandibular Margin Scale Score at Week 4, Week 12, and Week 24 After Treatment;NRS Score;Evaluation of Device Operational Performance; | — |
Countries
China
Contacts
Public ContactZhao Hongyi
Xuanwu Hospital, Capital Medical University
Outcome results
None listed