None listed
Conditions
Interventions
Experimental group:Implantation of polylactic acid facial implants
Control group:Implantation of polydioxanone facial implants
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 150 Years
Inclusion criteria
Inclusion criteria: 1. Men or non-pregnant women over the age of 18; 2. The subjects are willing to abide by the requirements of the research and provide signed written informed consent, including consent to the use of their facial images, etc.; 3. It is required that the test site has no ulceration or other skin diseases, and the test site has not received any treatment that stimulates inflammatory reactions within the past 6 months, and has not undergone facial cosmetic surgery injection treatment or face lift surgery; 4. Laboratory tests have normal liver and kidney functions; no history of severe allergic reactions or bleeding disorders; 5. No history of serious diseases of important organs or history of autoimmune diseases; 6. Female subjects are not breastfeeding, and there is no pregnancy plan within 6 months; 7. Select the 5-point method (none, mild, moderate, severe, extreme) of the nasolabial fold wrinkle severity rating (WSRS), and the subjects who are rated as moderate and above (The corresponding score is 3 to 5 points) will conduct clinical trials.
Exclusion criteria
Exclusion criteria: 1. Those who are allergic to polylactic acid polymers and their degradation products; 2. Allergy or history of allergy to lidocaine or other amide anesthetics; 3. Patients planning other facial plastic surgery within 24 weeks after surgery; 4. Patients with too little subcutaneous fat or muscle and skin laxity; 5. Serious aging patients who are overweight, have too much epidermis or are not suitable for linear micro-surgery; 6. Diabetes, hypertension and insufficiency of vital organs; 7. The client is mentally unstable and has high expectations for the effect of surgery, and has unrealistic requirements; 8. Those with skin or body infection; 9. Patients who have injected a large amount of fillers to cause sclerosis or are in the inflammatory phase of redness and swelling; 10. Scar constitution.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment effectiveness for wrinkle correction 24 weeks after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| GAIS score improvement rate;WSRS scoring efficiency;WSRS wrinkle severity grading numerical curves and variations;Immediate success with surgical implantation;Face-q cheek satisfaction evaluation;FACE-Q VAS age assessment;3D-stereoscopic digital imaging system evaluation of nasolabial folds; | — |
Countries
China
Contacts
Public ContactYang Songlin
Shanghai Sixth People's Hospital Ethics Committee
Outcome results
None listed