Nasolabial folds
Conditions
Interventions
experimental group:Amino acid crosslinked hyaluronic acid gel for injection
control group:Restylane hyaluronic acid gel for injection
Sponsors
Nanfang Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men or women aged 18-75 years (inclusive); 2. Intent to undergo correction of nasolabial folds (NLF) of wrinkle severity rating scale (WSRS) grade 3-4; 3. Willing to abstain from facial aesthetic treatment/procedure that could interfere with the study evaluation (e.g., thread lift, thermolift and thermage for midface lifting) for the duration of the study; 4. Understand and accept the obligation to follow trial procedures and to complete all the study visits; signed informed consent.
Exclusion criteria
Exclusion criteria: 1.Pregnant or breastfeeding women or planning to be pregnant; 2.Received treatment/procedure below the level of the lower orbital rim within 6 months prior to enrollment, such as facial aesthetic procedures (facial lifting, rhytidectomy or scar grinding surgery, etc.); radiofrequency, laser or chemical resurfacing; botulinum toxin injection (except for crow's feet); 3.Used anti-wrinkle medical products or anti-wrinkle drugs within 4 weeks prior to enrollment; 4.Received skin filler filling treatment below the level of the lower orbital rim within 12 months prior to enrollment; 5.Previous use of permanent filler (non-biodegradable) below the level of the lower orbital rim; 6.Known susceptibility to keloid formation, hypertrophic scarring or abnormal healing of skin soft tissue; 7. Active skin diseases, infections, wounds, herpes simplex ,psoriasis in the treatment area; 8. Received aspirin , NSAIDS ,anticoagulant or antiplatelet agents within 2 weeks prior to enrollment; 9. History of bleeding disorders or thrombotic diseases; 10. History of severe cardiovascular, liver, lung, nervous system or kidney diseases or autoimmune diseases, such as rheumatic disease, rheumatoid disease, lupus erythematosus; 11. History of hypersensitivity to hyaluronic acid or polysaccharide or planning to receive desensitization therapy in the study period; 12.Participated in clinical trials within 30 days prior to enrollment; 13.Other condition preventing the subject from entering the study in the investigator's opinion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective Rate of Rrinkle Correction; | — |
Secondary
| Measure | Time frame |
|---|---|
| Wrinkle Severity Rating Scale;Global Aestheyic Improvement Scale;Incidence of Remedial Treatment;Effective Rate of Rrinkle Correction; | — |
Countries
China
Contacts
Public ContactHu Zhiqi
Outcome results
None listed