Moderate to severe nasolabial fold wrinkles
Conditions
Interventions
Treatment group:The subjects underwent bilateral nasolabial fold wrinkle filling. After the subjects were officially enrolled, they received the first injection. Four weeks after the injection, based
Control group:The subjects underwent bilateral nasolabial fold wrinkle filling. After the subjects were officially enrolled, they received the first injection. Four weeks after the injection, based on
Sponsors
ZhuJiang Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Age >=18 years old, gender not limited; (2) There is a need to correct the wrinkles in the nasolabial fold; (3) The wrinkles in the nasolabial folds on both sides were evaluated as grade 3 or 4 by the severity of Wrinkles (WSRS). (4) Agree to maintain the existing skin care habits during the study period and not to use any other beauty treatments related to the study; (5) Voluntarily participate in this clinical trial and have signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Those prone to keloid, hypertrophic scar or any other abnormal healing. (2) Those allergic to the components of the test product (sodium hyaluronate) or with a history of severe allergic reactions. (3) Those with coagulation disorders (APTT > 1.5 times the upper limit of the normal value of the testing institution), or those who have received any thrombolytic, anticoagulant or antiplatelet drugs (such as warfarin, aspirin, etc.) within 2 weeks before screening. (4) Those with immune dysfunction such as autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, scleroderma, etc.). (5) Those with severe organic diseases, diabetes or other poor general conditions as judged by the researcher. (6) Those with tattoos, scars, deformities, unhealed wounds, active skin diseases or skin inflammation, or facial skin infectious diseases (such as eczema, acne, contact dermatitis, atopic dermatitis, herpes simplex, psoriasis, shingles, vitiligo, etc.), cancer or precancerous lesions on the midface that may affect the evaluation of treatment efficacy or increase the risk of treatment. (7) Those who have received any permanent or semi-permanent fillers (such as calcium hydroxyapatite, poly-L-lactic acid, polymethyl methacrylate, silicone, expanded polytetrafluoroethylene, polycaprolactone, etc.), autologous fat, midface lift (including thread lift) within 2 years. (8) Those who have received cross-linked hyaluronic acid or collagen injection treatment or other temporary fillers within 12 months before screening. (9) Those who have undergone surgery or facial cosmetic procedures such as botulinum toxin type A injection, laser resurfacing, radiofrequency treatment, ultrasound treatment, chemical peeling, dermabrasion, water light injection, intense pulsed light, photorejuvenation, etc. within 6 months before screening. (10) Those who have received or plan to receive immunosuppressive drugs or systemic corticosteroids within 1 month before screening or during the study period. (11) Those undergoing chemotherapy/radiotherapy. (12) Those with overly high expectations for treatment effects. (13) Pregnant women, lactating women or those with plans to conceive during the trial period. (14) Those with cognitive or mental disorders that prevent them from understanding and cooperating. (15) Those currently participating in a drug or device study, or those who have participated in a similar clinical trial within 3 months before signing the informed consent. (16) Those deemed unsuitable for participation in this clinical trial by the researcher. (17) The facial skin had received treatments such as non-crosslinked sodium hyaluronate or collagen mesotherapy, chemical peels, or photorejuvenation therapy. within 3 months before screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment Effectiveness Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in WSRS score;WSRS Score Improvement Rate;Global Aesthetic Improvement Scale (GAIS) Evaluation; | — |
Countries
China
Contacts
Public ContactQi Xiangdong
Southern Medical University Zhujiang Hospital
Outcome results
None listed