Moderate to severe nasolabial folds
Conditions
Interventions
Experimental group:The injection L-lactic acid-ethylene glycol copolymer microsphere filler produced by Jiangsu Xihong Biomedicine Co., LTD was used
Control group:Crosslinked sodium hyaluronate gel containing L-lactic acid-glycol copolymer microspheres produced by Ameco Technology Development Co., LTD
Sponsors
Beijing Friendship Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Ages ranging from 18 to 65 years inclusive, both male and female are eligible; 2. Subjects with a severity grade of 3 to 4 on both sides of the nasolabial folds during the screening period as rated by WSRS (evaluated by the researcher), and who desire correction; 3. Subjects who consent to not utilize any other laser or filler treatments related to the study during the research period; 4. Subjects who understand and abide by the trial requirements and can complete the entire follow-up process; 5. Subjects who voluntarily participate in this clinical study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Female subjects who are pregnant or have a positive urine or blood pregnancy test, or are breastfeeding or preparing to become pregnant during the trial period; 2. Female participants of childbearing age do not agree to use medically recognized contraceptive measures (such as oral contraceptives, condoms, intrauterine devices, etc.) during the trial period; 3. Subjects with visual impairment that might impact assessment; 4. Subjects with multiple history of severe allergy, genetic allergy, history of allergy to investigational products and excipients, history of allergy to lidocaine, and plan to undergo desensitization during the study; 5. Subjects whose laboratory tests (blood routine, urine routine, blood biochemistry, coagulation) were assessed by researchers to be clinically significant and unsuitable for facial filling; 6. Subjects of hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti HCV), AIDS virus antibody (anti HIV) or syphilis rapid plasma reagin test (PRP) is positive; 7. Subjects with bruising or skin disease in the treatment area that may affect the judgment of treatment effectiveness, or with active disease in or near the treatment site, such as inflammation, infection, or tumors/or unhealed wounds; 8. Subjects who are in the pre-stage or active stage of autoimmune disease and cannot avoid taking immunosuppressants during the trial; 9. Subjects who have received silicone or other permanent fillers in the treatment area; 10. Subjects who had received facial lifting surgery or other surgical treatment for improving facial wrinkles in the trial treatment area within 1 year before the screening period; 11. Subjects who were treated with semi-permanent fillers in the experimental treatment area; a. 6 months before signing the informed consent form - collagen; b. 12 months before signing the informed consent form - hyaluronic acid; c. 18 months before signing the informed consent form - L-lactic-ethylene glycol copolymer microspheres, polylactic acid microspheres, polycaprolactone or hydroxyapatite, etc. 12. Subjects plan to receive other wrinkle removal treatments in the treatment area within 6 months prior to the screening period or during the trial, such as botox injection, radiofrequency therapy, and focused ultrasound therapy; 13. Subjects undergo laser skin, grinding, chemical peeling and other treatments in the treatment area within 6 months before the screening period or during the trial; 14. People who have a history of bleeding or are currently on treatment regimens for other diseases that contain drugs known to prolong clotting time (e.g., aspirin, non-Zietic anti-inflammatory drugs, clopidogrel, warfarin, high-dose vitamin C or E, Chinese herbal supplements containing garlic, ginkgo or ginseng) and are unwilling or unable to stop using these drugs within 2 weeks prior to screening; 15. Subjects with a history of serious organ disease (cardiovascular system, liver, lung, nervous system and kidney, etc.), a history of mental illness or autoimmune disease (rheumatism, rheumatoid disease, lupus erythematosus, etc.), uncontrolled diabetes, active herpes, and coagulopathy; 16. Subjects who are taking large doses of hormones or plan to use large amounts of hormones during the study; 17. Subjects who plan to undergo any surgery or take any medication (e.g., systemic corticosteroids, diet drugs, bariatric surgery) that may result in significant weight change during the study period; 18. Subjects with
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective rate of correcting nasolabial folds in subjects at week 52 after completing injection filling therapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| The effective rate of correcting nasolabial folds in subjects on the day of injection filling treatment and at weeks 4, 12, 24, and 36 after treatment;Global beauty effect grading score evaluated by researchers (face-to-face participants) and subjects separately(GAIS);Severity score of nasolabial folds evaluated by face-to-face subjects by researchers(WSRS);Severity score of nasolabial folds evaluated by researchers on facial photographs of subjects;Subjects' satisfaction ratings;Maintenance time for wrinkle improvement; | — |
Countries
China
Contacts
Public ContactXu Wei
Dermatology Department of Beijing Friendship Hospital
Outcome results
None listed