Nasolabial folds
Conditions
Interventions
Experimental group:Received treatment with injectable hydroxyapatite microsphere tissue filler.
Control group:Received treatment with injectable modified sodium hyaluronate gel.
Sponsors
Chongqing Xingrong Plastic Surgery Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 75 years old, inclusive, regardless of gender; 2. Subjects whose bilateral nasolabial folds are judged by the investigator to be moderate to severe (scoring 3 to 4 points on the wrinkle severity grading scale) and who wish to improve their appearance; 3. Willing to refrain from undergoing other cosmetic treatments on the face below the infraorbital rim during the study period; 4. Voluntarily participate in the study, sign the informed consent form, fully understand the study content, procedures, and possible adverse reactions, and agree to participate in treatment, visits, and examinations according to the study protocol.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding women, or women planning to become pregnant during the trial period; 2. Individuals with severe mental disorders, psychological disorders, personality disorders, or those currently taking antipsychotic medications; 3. Individuals with acute allergic or inflammatory skin diseases on the face (such as dermatitis, eczema, acne, seborrheic dermatitis, rosacea), unhealed wounds, precancerous lesions, or cancer; 4. Individuals with systemic infections; 5. Individuals with coagulation disorders or those who have used anticoagulant or antiplatelet aggregation drugs (such as aspirin, heparin, warfarin, etc.) within the two weeks prior to injection; 6. Individuals with a history of severe diseases of vital organs (cardiovascular, pulmonary, hepatic, renal, and nervous systems, etc.), or a history of immune dysfunction (such as autoimmune diseases, immunodeficiency); 7. Individuals with a tendency to form keloids; 8. Individuals allergic to any component of this product (such as hyaluronic acid, hydroxyapatite), allergic to local anesthetics (such as lidocaine or other amide anesthetics), or with a history of severe or multiple allergies; 9. Individuals with sensory impairment, numbness, or neuralgia. including facial sensory abnormalities; 10. The following prior treatments or planned treatments during the study period exist in the facial area below the infraorbital rim: previous fat grafting or implantation of permanent implants such as polymethyl methacrylate, silicone, or polytetrafluoroethylene; semi-permanent fillers such as hydroxyapatite or poly-L-lactic acid within 36 months prior to enrollment; temporary fillers (such as hyaluronic acid) or facial rhytidectomy within 12 months prior to enrollment; botulinum toxin or collagen injections, or energy-based or radiofrequency treatments (such as ultrasound, Thermage), lipolysis treatments (such as deoxycholic acid injections, cryolipolysis), or ablative treatments (such as ablative laser, chemical peels) within 6 months prior to enrollment; mesotherapy (such as hyaluronic acid injections, microneedling) or non-ablative laser treatments within 3 months prior to enrollment; 11. Participation in any other clinical trial product within 30 days prior to enrollment or planned participation in other clinical trials during the study period; 12. Other conditions that the investigator deems unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in WSRS score of nasolabial fold wrinkles evaluated by EI 12 months after the last injection compared to the baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in WSRS score of nasolabial fold wrinkles;TI's evaluation of the effectiveness rate of correcting nasolabial folds.;The overall aesthetic improvement rate (GAIS) as evaluated by study participants.;Study participants assessed injection-related pain immediately and at 30 minutes post-injection.; | — |
Countries
China
Contacts
Public ContactLi Shirong
Chongqing Xingrong Plastic Surgery Hospital
Outcome results
None listed