Correcting midface volume loss and/or midface contour defects
Conditions
Interventions
Test group:Mid-facial injection of cross-linked sodium hyaluronate gel containing poly-L-lactic acid microspheres
Control group:Mid-facial injection of modified sodium hyaluronate gel for injection
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Able to understand and willing to strictly comply with the clinical trial protocol to complete this trial, and provide signed informed consent; 2. Male or female aged 18-65 years (inclusive); 3. Both sides rated 2–4 on the Mid-Face Volume Scale (MMVS), with a difference of no more than 1 grade between sides, and willing to undergo correction; 4. Agree not to use other cosmetic treatments related to the study (including other facial areas such as the forehead or perioral area) during the study period.
Exclusion criteria
Exclusion criteria: 1. Allergic to polylactic acid (such as polylactic acid microspheres, poly-L-lactic acid, etc.), sodium hyaluronate, sodium carboxymethyl cellulose, streptococcal protein, lidocaine, or other local anesthetics, or currently experiencing an allergic reaction, or have a history of multiple severe allergies, or plan to undergo desensitization treatment during the study; 2. The treatment area has previously received permanent dermal fillers, semi-permanent dermal fillers, or other fillers with absorption periods longer than 1 year (such as fat grafting); 3. The treatment area has undergone facial lifting surgery, thread lifting, or other procedures to improve facial wrinkles within 1 year prior to screening; 4. The treatment area has received injections of sodium hyaluronate or other absorbable products within 1 year prior to screening; 5. The treatment area has received other treatments such as botulinum toxin injection, radiofrequency therapy, focused ultrasound therapy, laser resurfacing, dermabrasion, or chemical peeling within 6 months prior to screening; 6. Participants who have undergone or plan to undergo oral or nasal surgery within 6 months prior to enrollment that may affect efficacy evaluation (including dental implants, excluding fillings or dental cleaning); 7. Use of anticoagulants, antiplatelet agents, or thrombolytic therapy (such as warfarin, aspirin, etc.) within 14 days prior to treatment; 8. Treatment areas with scars, infection, active herpes outbreaks, active inflammation, unhealed wounds, or other skin conditions or scar-prone conditions that may affect treatment efficacy evaluation; 9. Treatment areas prone to edema that may affect efficacy evaluation; 10. Plans to lose weight or undergo any procedure, medication, or other treatment during the study that could result in significant weight changes (e.g., liposuction, glucocorticoids); 11. Having systemic or treatment area fat tissue abnormalities or fat metabolism disorders, or diagnosed malnutrition; 12. History of severe disease in essential organs; 13. Abnormal liver or kidney function by laborato
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of subjects with MMVS rating improvement >=1 level compared to baseline in the evaluator-assessed group; | — |
Secondary
| Measure | Time frame |
|---|---|
| The percentage of subjects whose MMVS ratings improved by >= 1 level compared to baseline, as evaluated by the evaluators;Percentage of subjects with MMVS rating improvement >= 1 compared to baseline evaluated by treatment researchers;Evaluate the improvement rate of GAIS scale by the evaluation researcher;Evaluate the improvement rate of GAIS scale by subjects;Treatment satisfaction rate evaluated by subjects;Improvement value of mid face volume compared to baseline evaluated by 3D device modeling; | — |
Countries
China
Contacts
Public ContactBao Shiwei
Beijing Hospital
Outcome results
None listed