Nasolabial wrinkles
Conditions
Interventions
Test Group:Tissue matrix filler for injection
Control Group:Collagen implants
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years old, gender unlimited; 2. Subjects who are willing to correct nasolabial wrinkles; 3. According to the blind evaluator, the nasolabial wrinkle Severity Rating Scale (WSRS) was moderate or severe degree (level 3 on both sides or level 4 on both sides); 4. Be able to tolerate mild pain; 5. Subject has reasonable expectations, understands and complies 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. Patients 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 agents, anticoagulants or antiplatelet agents (e.g., warfarin, aspirin, clopidogrel, etc.) during the 2 weeks prior to inclusion; 4. Subjects with scarring 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 study evaluation; 5. Had received semi-permanent fillers or permanent facial implants (e.g., calcium hydroxyapatite, poly-l-lactic acid, polymethyl methacrylate, silicone, expanded polytetrafluoroethylene, etc.) at the injection site and midface, or planned to have any of these implants implanted during the study period; 6. Had 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 do so 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, drilling, 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. Patients with severe functional insufficiency of vital organs (such as brain, heart, lung, liver, kidney, etc.) judged by researchers, Such as severe cardiovascular and cerebrovascular diseases (3 Hospitalization or cardiac surgery for myocardial infarction within the last month, history of congestive heart failure or myocardial infarction, severe unstable arrhythmia, hypertrophic cardiomyopathy, severe aortic stenosis, aneurysm, stroke, etc.), severe lung disease (moderate to severe pneumonia, respiratory failure, etc.), uncontrolled diabetes, epilepsy, liver function (ALT, AST) >2 times ULN and renal function (Cr) >1.5 ULN; 10. Subjects with a history of the severe malignant tumor 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), active connective tissue disease (e.g., rheumatoid arthritis, scleroderma, and systemic lupus erythematosus), periods of immunosuppressive or regulatory treatment, and active skin infections; 13. Had 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. The subject is participating in another clinical trial within 30 days prior to enrollment in this study or is currently participating in another clinical trial; 16. The presence of facial hair
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficiency rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| The efficiency of wrinkle correction;The improvement rate of the overall beauty effect;Subject satisfaction; | — |
Countries
China
Contacts
Public ContactBi Hongsen
Peking University Third Hospital
Outcome results
None listed