None
Conditions
Interventions
Experimental Group:Subjects in the experimental group received the high-intensity focused ultrasound (HIFU) therapy device from Keytai Longyu (Shanghai) Medical Technology Development Co., Ltd. to imp
Control group:Subjects in the control group received clinical follow-up. At Week 12 after randomization, those who were willing to receive treatment, met the inclusion criteria, and did not meet the e
Sponsors
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
20 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 20 years old and <= 65 years old, with no restrictions on gender; 2. Facial and neck skin laxity with a need for improvement, skin laxity that can be determined by the researcher to be improved by non-invasive intervention, and not meeting the criteria for surgical intervention; 3. Fitzpatrick skin type classification II~? on the face; 4. The subject can understand the purpose of the study, show sufficient compliance with the study protocol, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Presence of scars, hair (i.e., beard, sideburns, etc.), tattoos (excluding eyebrow tattoos), or significant facial/neck asymmetry in the treatment area, which the researcher judges may affect the evaluation of effectiveness; 2. Presence of any open wounds, active skin diseases, inflammation, or infections (e.g., herpes, acne, dermatitis, psoriasis, shingles, mycosis, etc.) in the treatment area; 3. History of keloid formation or keloid-prone constitution; 4. Comorbid collagen connective tissue disease; 5. Comorbid severe diseases such as malignant tumors, severe cardiovascular and cerebrovascular diseases, liver/kidney dysfunction, diabetes, etc., which the researcher judges as unsuitable for enrollment; 6. Presence of cancer or precancerous lesions in the treatment area, or prior local radiotherapy; 7. Presence of unknown fillers or any metal implants (excluding dental implants) under the treatment area; 8. History of active implant placement; 9. Previous full-face surgical treatment, such as fat grafting, facial lifting (thread embedding), silicone implantation, etc.; 10. Oral surgery (e.g., orthodontics, tooth extraction, dental implantation) within 3 months before screening, which the researcher judges may affect effectiveness evaluation, or planned dental surgery or plastic surgery affecting facial morphology during the trial; 11. History of skin anti-wrinkle treatment (e.g., botulinum toxin) in the treatment area within 9 months before screening; 12. History of monopolar radiofrequency or focused ultrasound treatment in the treatment area within 12 months before screening; history of short-acting hyaluronic acid treatment within 6 months before screening, or medium/long-acting hyaluronic acid filling treatment within 24 months before screening; history of water-light treatment within 6 months before screening; history of facial filling treatment with poly-L-lactic acid or polycaprolactone (PCL) within 24 months before screening; or history of facial filling treatment with hydroxyapatite within 24 months before screening; 13. History of bipolar or multipolar radiofrequency device treatment (including home-use radiofrequency therapy devices) within 6 months before screening, or ablative laser treatment; or history of other photoelectric treatments such as facial photorejuvenation within 3 months before screening; 14. Chemical peeling treatment within 6 months before screening or planned during the trial; 15. Use of topical tretinoin or isotretinoin within 1 month before screening or planned during the trial; or oral tretinoin or isotretinoin treatment within 3 months before screening or planned during the trial; 16. History of facial nerve palsy; 17. Severe solar elastosis; 18. Severe coagulation dysfunction (PT or APTT >= 2 times the upper limit of normal value); 19. Planned lifestyle changes or other interventions that may significantly affect body weight during the trial; 20. Pregnant or lactating women; 21. Participation in drug clinical trials within 3 months before screening or ongoing participation; or participation in other medical device clinical trials within 1 month before screening or ongoing participation; 22. Other conditions judged by the researcher as unsuitable for participation in this clinical trial, such as poor compliance or perceptual impairment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Global Aesthetic Improvement Rate of Face and Neck at Week 12 After Treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Global Aesthetic Improvement Rate of Face and Neck at Week 4 and Week 24 After Treatment;Subject Self-Assessment of Global Aesthetic Effect of Face and Neck at Week 4, Week 12, and Week 24 After Treatment;Mandibular Margin Grading at Week 4, Week 12, and Week 24 After Treatment;Numerical Rating Scale Score;Evaluation of Device Operational Performance; | — |
Countries
China
Contacts
Public ContactHongyi Zhao
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Outcome results
None listed