nasolabial wrinkles evaluated as moderate and severe
Conditions
Interventions
Experimental group:unilateral injection dose doesn’t exceed 1.4mL, i.e. the total injection dose of initial therapy and supplemental injection (if applicable) of left and right nasolabial wrinkles not
Control group:unilateral injection dose doesn’t exceed 1.5mL, i.e. the total injection dose of initial therapy and supplemental injection (if applicable) of left and right nasolabial wrinkles not grea
Sponsors
The Second People's Hospital of Guangdong Province
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged 18-65 years (including 18 and 65), no gender limits; 2. Wrinkle Severity Rating Scale (WSRS) score of 3-4; 3. Understand purpose, method and effect of this study, and be willing to sign informed consent form voluntarily; 4. Capable to complete the whole study according to requirements.
Exclusion criteria
Exclusion criteria: 1. Had taken drug which prolong blood clotting time 10 days prior to treatment or plan to take such drug (e.g. aspirin(or other NSAIDs), clopidogrel, warfarin); 2. Any temporary filler therapy with hyaluronic acid or collagen product at the test injection site within 12 months prior to study screening; 3. Any facial tissue transplantation, or tissue augmentation using silica gel, calcium hydroxyapatite, polymethyl methacrylate, poly-L-lactic acid or other permanent, semi-permanent or unknown filler; 4. Any creotoxin injection, laser resurfacing, intense pulsed light, radio frequency, dermabrasion, chemical peeling or other therapy at the test injection site within 6 months prior to study screening; 5. Any facial plastic surgery or surgical face lift under the inferior orbital rim within 6 months prior to study screening; 6. Subject planning to undergo any surgical procedure that may result in significant body weight change or take any drug that may result in significant body weight change (e.g. systemic corticosteroid hormones, diet pills, bariatric surgery) during study; 7. Any dental operation, tooth extraction or tooth implantation within 3 months prior to study screening; 8. Subject planning to receive facial aesthetic surgery, dental operation, tooth extraction or tooth implantation during this study. 9. Any active inflammation, skin infection, herpes simplex and etc. at the test treatment region; 10. With history of malignant tumor; 11. Women who are pregnant or lactating or preparing for pregnancy; 12. Subject and spouse of childbearing age do not agree to take medically approved contraception measures during study (e.g. oral contraceptive, condom, intrauterine device, and etc.); 13. Allergic to the product, or with history of severe allergy or hereditary allergic reaction; 14. With history of severe disease of major organ or autoimmune disease; 15. With history of hypertrophic scar or keloid; 16. With abnormal lab test result evaluated by investigator as clinically significant after re-test; 17. Subject participating in other clinical study without reaching the end point; 18. Diabetics with poor blood sugar control; 19. Considered by investigators as not suitable for participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects whose WSRS rating improved >=1 level compared with baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects whose WSRS rating improved >=1 level compared to baseline;GAIS improvement;GAIS improvement; | — |
Countries
China
Contacts
Public ContactLuo Shengkang
Outcome results
None listed