Moderate to severe nasolabial fold wrinkles
Conditions
Interventions
Control group:Injection of polylactic acid facial filler(Changchun shengboma biomaterials Co., Ltd.)
Experimental group:Injection of polylactic acid facial filler(Jinhua Apre Biotechnology Co., Ltd.)
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age: 18 years old or above, gender not restricted; 2. Subjects who are willing to correct the nasolabial fold wrinkles; 3. According to the evaluation by the blind reviewers, the subjects whose bilateral nasolabial folds were classified as grade 3 or grade 4 on the WSRS scale; 4. Be able to understand the purpose of the trial, voluntarily participate in the trial, and be willing to sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Those who are known to be allergic to polylactic acid products or to any component of the test medical device/control medical device; or those who have a known severe allergic history or history of anaphylactic shock; 2. Those with abnormal coagulation mechanisms during the screening period (Activated Partial Thromboplastin Time (APTT) > 1.5 times the upper limit of the normal value), or those who have used any thrombolytic agents, anticoagulants or antiplatelet drugs (such as warfarin, aspirin, etc.) within 2 weeks before the screening; 3. Those with tattoos, piercings, obvious facial hair, scars, deformities, non-healed wounds, abscesses, granulomas, active periorbital infections or persistent infections, canceration or precancerous lesions, malignancies or unknown nature of skin masses in the injection area and adjacent areas; 4. Those with active skin diseases or inflammations or infections (such as herpes, acne, eczema, dermatitis, psoriasis, shingles, mycosis, papilloma, etc.), as determined by the investigator, which may affect the evaluation of therapeutic effect or increase the risk of treatment; 5. Those who have received or plan to receive any permanent filler (such as polymethyl methacrylate, silicone, expanded polytetrafluoroethylene, etc.) or other unknown material injections in the injection area and adjacent areas during the trial period; 6. Those who have received or plan to receive calcium hydroxyapatite, poly-L-lactic acid, poly-lactic acid, poly-bifurcated lactic acid, poly-hydroxybutyrate, etc. treatment in the injection area and adjacent areas within 24 months before the screening; 7. Those who have received or plan to receive autologous fat transplantation, absorbable sutures treatment or facial lifting surgery for facial wrinkles improvement in the injection area and adjacent areas within 12 months before the screening, as determined by the investigator, which may affect the evaluation of therapeutic effect or increase the risk of treatment; 8. Those who have received or plan to receive cross-linked hyaluronic acid sodium injection filling treatment in the injection area and adjacent areas within 6 months before the screening; 9. Those who have received or plan to receive cosmetic treatment or facial surgery in the injection area and adjacent areas within 3 months before the screening (such as botulinum toxin treatment, non-cross-linked hyaluronic acid filling, collagen filling, radiofrequency treatment, focused ultrasound treatment, laser skin resurfacing, moderate or deeper chemical peeling, liposuction, fat reduction, photodynamic therapy or other ablation surgeries (except for injectable hyaluronic acid sodium compound solution)); 10. Those who have received or plan to receive injectable hyaluronic acid sodium compound solution, photobiomodulation, intense pulsed light, microneedles (except radiofrequency microneedles), extremely superficial or superficial chemical peeling (such as A alcohol, alpha-hydroxy acid, salicylic acid, etc.) treatment in the injection area and adjacent areas within 3 months before the screening; 11. Those with active autoimmune diseases (such as inflammatory bowel disease, Hashimoto's thyroiditis) or history of such diseases, active connective tissue diseases (such as rheumatoid arthritis, scleroderma and systemic lupus erythematosus) or history of such diseases; 12. Those who have received or plan to receive chemotherapy, immunosuppressant treatment, immunomodulator treatment (su
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effective rate of improvement in nasolabial fold wrinkles 12 months after the last injection (evaluated by a third-party independent blinded evaluation committee based on photo assessment); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall aesthetic improvement effect evaluation (by the treating researcher and the subjects);The effective rate of improvement for nasolabial fold wrinkles (evaluated by blinded evaluators conducting on-site evaluations);Subject satisfaction;The effective rate of improvement in nasolabial fold wrinkles (evaluated by a third-party independent blind evaluation committee based on photo assessment, except for the evaluation time points of the; | — |
Countries
China
Contacts
Public ContactNanze Yu
Peking Union Medical College Hospital
Outcome results
None listed