Nasolabial groove wrinkle
Conditions
Interventions
Test (left) - control (right) group:Sodium Hyaluronate Gel for Injection
Test (right) - control (left) group:Sodium Hyaluronate Gel for Injection
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Subjects who meet all the following conditions can be enrolled in this study: (1) Voluntary participation and signing of written informed consent; (2) The age is 18~65 years old, regardless of gender; (3) The severity score (WSRS) of bilateral nasolabial furrow wrinkles assessed by the blind evaluation researcher is moderate or severe (grade 3 or 4), and the bilateral scores need not be consistent, and the treatment researcher approves the score; (4) During the study period, he voluntarily gave up any other facial surgery under the eyes (including nose); (5) Willing to complete all visits according to the requirements of the test plan.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following conditions shall be excluded: (1) Active infection or inflammation at the injection site or skin diseases affecting the evaluation (such as psoriasis, herpes simplex, etc.); (2) The nasolabial groove has a history of pigmentation or hypopigmentation, scar formation or hypertrophic scar; (3) The injection site has been used or planned to receive permanent skin fillers (such as silicone, polymethylmethacrylate) during the study; (4) The injection site has been injected with modified sodium hyaluronate gel for injection or other non permanent skin filler (CaHA [calcium hydroxyapatite]) or PLLA [poly L-lactic acid]) within 12 months; (5) Botulinum toxin injection or fat injection has been carried out on the immediate face within 6 months before the injection or is planned during the study; (6) After the evaluation of the researcher, medical cosmetic surgery (such as laser therapy, radiofrequency therapy, chemical exfoliation, non-invasive tightening and pulling therapy, etc.) that affected the WSRS score of NLF was performed on the immediate face within 3 months before the injection or planned during the study period; (7) It has been used within 2 weeks before the start of the study, or it is planned to use any prescription medicine for the treatment of wrinkles in the nasolabial groove, topical steroids, skin irritant topical preparations or pigment preparations (suntan repair preparations) during the study; (8) It has been used in the past three months, or planned to use systemic immunosuppressants (calcineurin inhibitors, such as cyclosporine, rapamycin, tacrolimus, etc.) or systemic steroid drugs (such as dexamethasone, prednisone, hydrocortisone, prednisone acetate, etc.) during the study period (patients who use nasal/inhaled steroids can be considered into the group); (9) Severe liver and kidney damage (such as alanine aminotransferase and aspartate aminotransferase>2.5 times the upper limit of normal value; creatinine>1.5 times the upper limit of normal value); (10) Abnormal coagulation function has clinical significance or is given antithrombotic agents (except low-dose aspirin [100 mg, maximum 300mg/day]) from 2 weeks before to 2 weeks after the application of medical devices for clinical trials, and vitamin E preparations and non-steroidal anti-inflammatory drugs (NSAID) preparations from 1 week before to 1 week after the application; (11) Need to be taken during injection in the test ß Receptor blockers (such as atenolol, metoprolol, bisoprolol, propranolol, etc.); (12) Severe atrioventricular block (second degree II and third degree atrioventricular block); (13) Known to be allergic to lidocaine and other similar amide anesthetics, sodium hyaluronate or any component of the device; Or patients with a history of streptococcus; Or other severe allergic history, judged by the researcher as unsuitable for participation; (14) Those with autoimmune diseases or their history; (15) Syphilis or human immunodeficiency virus (HIV) infection; (16) Patients with serious diseases of cardiovascular system, digestive system, respiratory system, endocrine system and central nervous system, and patients who have had or are now suffering from mental diseases that affect clinical trials; (17) Being receiving orthodontics or planning to carry out orthodontics, tooth extraction and dental implantation during the study period (such as involving the extraction and implantation of the anterior tee
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wrinkle rating; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall beauty effect score;Pain score; | — |
Countries
China
Contacts
Public ContactXu Jinghua
Ethics Review Committee of Huashan Hospital, Fudan University
Outcome results
None listed