None listed
Conditions
Interventions
Experimental group:Inject a polycaprolactone filler for injection
Control group:Inject polycaprolactone microsphere filler for injection
Sponsors
Yanbian University Affiliated Hospital (Yanbian Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects aged >18 years; 2. Subjects with WSRS score of 3 or 4 for bilateral nasolabial wrinkles who want correction; 3. Subjects who agree not to use other study-related cosmetic treatments (including other parts of the face such as the forehead and around the eyes) during the study; 4. Subjects who understand and comply with the test requirements and can complete the whole follow-up process; 5. Voluntarily participate in the clinical study and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Subjects who had received facial lift surgery or catch-line lift and other surgical treatments to improve facial wrinkles at the treatment site within 1 year before the screening period; 2. Subjects received sodium hyaluronate or other semi-permanent dermal fillers in the treatment area (below orbital margin, above oral area) within 1 year prior to the screening period; 3. In the 6 months prior to the screening period, subjects underwent other wrinkle removal treatments in the treatment area (below the orbital margin and above the mouth), such as radiofrequency therapy, focused ultrasound therapy, laser peels, grinding, chemical stripping, etc.; 4. Subjects who have received permanent dermal fillers in the treatment area; 5. Subjects have used or plan to use anticoagulant, antiplatelet, or thrombolytic therapy (e.g., warfarin, aspirin, etc.) within 14 days before study treatment and 3 days after treatment; 6. The subject is known to be allergic to polycaprolactone, sodium carboxymethyl cellulose, glycerin, and lidocaine or other local anesthetics; Or have a history of multiple severe allergies, inherited allergies and plan to undergo desensitization therapy during the study period; 7. Subjects who have suffered from hypertrophic scar or scar constitution; Or subjects with scar or skin disease in the treatment area that may affect the assessment of treatment effectiveness, or with active inflammation and/or open wounds; 8. Local ulceration of the face or other active skin diseases, such as psoriasis and herpes simplex; Subjects with skin infections or a history of skin malignancies in the treatment area; 9. The subject has a history of serious diseases of vital organs or autoimmune diseases; 10. Subjects who have received or plan to receive immunosuppressive or systemic hormone therapy (including intranasal/inhaled hormones) in the past 3 months; 11. Laboratory tests judged by researchers to be abnormal and clinically significant; 12. Subjects with a history of acute and chronic neuromuscular disease or myasthenia gravis; 13. Intravenous or oral aminoglycoside antibiotics within the last 2 weeks; 14. Pregnant or lactating subjects; Female subjects of reproductive age do not consent to use medically approved contraceptive methods (such as oral contraceptives, condoms, etc.) during the study; 15. Subjects who have participated in other clinical trials within 30 days prior to the screening period; 16. Subjects deemed unsuitable for this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of subjects with >=1 grade improvement on the Wrinkle Severity Rating Scale (WSRS) from baseline was evaluated by evaluators; | — |
Secondary
| Measure | Time frame |
|---|---|
| The improvement of the Facial Global Aesthetic Improvement Scale (GAIS) was evaluated by the evaluation researcher and the subjects; | — |
Countries
China
Contacts
Public ContactJin Zhehu
Yanbian University Affiliated Hospital (Yanbian Hospital)
Outcome results
None listed