submental contour prominence
Conditions
Interventions
Intervention Group:microwave therapy
control group:none
Sponsors
PEKING UNIVERSITY SHENZHEN HOSPITAL
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-65 years (inclusive), regardless of gender; 2. Subjects with a score of 2-3 on the Clinician-Reported Submental Fullness Rating Scale (CR-SMFRS) assessed by investigators on-site; 3. Body Mass Index (BMI) <= 30 kg/m^2 at screening; 4. Able to understand this clinical trial and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Subjects with a score of 4 on the Submental Skin Laxity Grading Scale (SMSLG) assessed by investigators on-site at screening. 2. Plan to receive aesthetic procedures in the submental area during the trial period, including but not limited to dermal filler injection, facelift, photoelectric therapy, hydro-glow injection, mechanical microneedling or radiofrequency microneedling, chemical peeling, or surgery. 3. Have received radiofrequency or ultrasound therapy, chemical peeling, or botulinum toxin injection in the anterior cervical and submental areas within 3 months prior to informed consent. 4. Have received the following dermal fillers in the anterior cervical and submental areas before screening: (1) Non-cross-linked hyaluronic acid filler within 6 months prior to informed consent; (2) Biodegradable dermal fillers (e.g., cross-linked hyaluronic acid, collagen, etc.) within 12 months prior to informed consent; (3) Semi-permanent dermal fillers within 2 years prior to informed consent; (4) Permanent dermal fillers at any time prior to informed consent. 5. Have a history of previous surgery, liposuction, or lipolytic agent injection in the submental area. 6. Have obvious scars, retrogenia, or other conditions in the chin and anterior cervical areas at screening, which are assessed by investigators to potentially affect trial outcome evaluation. 7. Have malignant or premalignant lesions in the intended treatment area at screening. 8. Subjects with active inflammatory dermatoses (e.g., acne, herpes zoster, etc.) in the intended treatment area at screening, who are deemed ineligible by investigators. 9. Presence of pathological or local morphological abnormalities (e.g., goiter, Madelung's disease, platysma prominence at rest, etc.) that cause submental enlargement or interfere with investigators' assessment of submental contour at screening. 10. Subjects with malignant thyroid neoplasms at screening. 11. Subjects with currently progressive malignant tumors. 12. Subjects assessed by investigators to be at risk of unacceptable aesthetic outcomes after treatment. 13. Subjects with a history of hypertrophic scar tendency or keloids, who are judged by investigators to have potential risks to efficacy evaluation or subject safety after treatment. 14. Subjects presenting with dysphagia symptoms or related diseases at screening. 15. Subjects planning to undergo any surgery or take any medications that may cause a significant weight change (>= 10%) during the trial period (e.g., systemic corticosteroids, weight-loss agents, bariatric surgery). 16. Subjects with hepatic/renal failure or dysfunction at screening; or laboratory test results showing aspartate transaminase (AST) or alanine transaminase (ALT) > 2 times the upper limit of normal (ULN), or serum creatinine (Scr) > 1.5 times the ULN. 17. Subjects with positive results for any one of hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, and Treponema pallidum (TP) antibody at screening. 18. Subjects with cardiac insufficiency, severe organic heart disease, severe vascular disease, active phlebitis, thrombophlebitis or embolism at screening. 19. Subjects with a previous diagnosis of Type I/Type II diabetes mellitus currently in decompensated stage (e.g., diabetic ketoacidosis, hyperosmolar hyperglycemic state). 20. Subjects with coagulation disorders at screening; or laboratory tests showing prothrombin time (PT) pr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Chin Fat Rating Scale (CR-SMFRS) Improvement Rate Reported by Clinicians; | — |
Secondary
| Measure | Time frame |
|---|---|
| Submental Skin Laxity Grading Scale (SMSLG) score;Patient-Reported Submental Fat Impact Scale (PR-SMFIS) score;Post treatment pain score;Submental tissue volume/thickness measurements;Device performance evaluation;AE/SAE incidence rate;Clinician Reported Submental Fullness Rating Scale (CR-SMFRS) score;Patient Reported Submental Fullness Rating Scale (PR-SMFRS) score;Global Aesthetic Improvement Scale;Device Defect; | — |
Countries
China
Contacts
Public ContactBo Yu
PEKING UNIVERSITY SHENZHEN HOSPITAL
Outcome results
None listed