Nasolabial wrinkles
Conditions
Interventions
Experimental Group:Composite tissue material filler for injection
Control Group:Polylactic acid facial filler
Sponsors
Second People's Hospital of Guangdong Province
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years, no gender limit; 2. Subjects willing to correct nasolabial wrinkles; 3. Subjects with moderate or severe nasolabial wrinkle Severity Scale (bilateral level 3 or bilateral level 4) as assessed by the blind evaluator; 4. Can tolerate mild pain; 5. Subject has reasonable expectations to understand and comply with study procedures and all visit schedules; 6. Subjects who voluntarily decided to participate in the study and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Those who are known to be allergic to pig-derived materials; 2. Known history of severe allergic reaction or anaphylactic shock; 3. Subjects with abnormal coagulation mechanism (activated partial thromboplastin time (APTT) >1.5 times the upper limit of normal) during the screening period, or who had received any thrombolytic agent, anticoagulant or antiplatelet drugs (such as warfarin, aspirin, clopidogrel, etc.) during the 2 weeks prior to inclusion; 4. Scar or skin disease (i.e., active skin disease [facial psoriasis, eczema, rosacea, perioral dermatitis, acne, herpes, etc.), inflammation or unhealed wounds in the injection area and mid-face that may affect the subjects evaluated in the study; 5. Had received semi-permanent fillers or permanent facial implants (e.g., calcium hydroxyapatite, poly-l-lactic acid, polymethyl methacrylate, organosilicone, expanded polytetrafluoroethylene, etc.) at the injection site and midface, or planned to have any of these implants during the study period; 6. Received temporary dermal fillers (e.g., hyaluronic acid or collagen) at the injection site and midface within 12 months prior to enrollment, or planned to receive such treatments during the study period; 7. Facial fillers, Botox injections, beauty plastic therapy, or cosmetic procedures (e.g., facial liposuction, cosmetic surgery, face thinning, light conditioning, intense pulsed light, radiofrequency, dermelling, laser or chemical exfoliation, or other ablation procedures) using fat injections at the injection area and midface within 6 months prior to enrollment; Or plan to undergo any such treatment during the study period; 8. Subjects who had received oral treatment (such as tooth extraction, orthodontic or dental implant) that affected facial evaluation within the 6 months prior to enrollment, or who planned to have any such surgery during the study period; 9. According to the researchers, the function of vital organs (such as brain, heart, lung, liver, kidney, etc.) is severely deficient, such as severe cardiovascular and cerebrovascular diseases (hospitalization or cardiac surgery due to myocardial infarction within 3 months, congestive heart failure or myocardial infarction history, severe unstable arrhythmia, hypertrophic cardiomyopathy, severe aortic stenosis, aneurysm, stroke, etc.), serious lung diseases (moderate to severe pneumonia, respiratory failure, etc.), uncontrolled diabetes, epilepsy, liver function (ALT, AST) >2 ULN, renal function (Cr) >1.5 ULN; 10. Subjects with a history of severe malignant tumors within 5 years prior to enrollment; 11. Plan to have a significant weight change (more than 10% of body weight) during the study period; 12. Subjects with active autoimmune disease (e.g., inflammatory bowel disease) or history, active connective tissue disease or history (rheumatoid arthritis, scleroderma, and systemic lupus erythematosus), periods of immunosuppressive or regulatory treatment, and active skin infections; 13. Received chemotherapy, immunosuppressants, immunoregulatory therapies (such as monoclonal antibodies) or systemic corticosteroids (other than inhaled corticosteroids) within 3 months prior to enrollment; 14. Subjects who are pregnant or plan to become pregnant during the study period, or who are breastfeeding; 15. Subjects are participating in other clinical trials within 30 days prior to enrollment in this study or are currently participating in other clinical trials; 16. The presence of facial hair (e.g
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficiency rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Effective in correcting nasolabial furrows;Improvement rate of the Global Beauty Effect Scale;Subject satisfaction; | — |
Countries
China
Contacts
Public ContactLuo Shengkang
Second People's Hospital of Guangdong Province
Outcome results
None listed