nasolabial fold wrinkles
Conditions
Interventions
Test group:One side of nasolabial sulcus received injection of cross-linked sodium hyaluronate gel containing lidocaine for injection
cnotrol group:One side of nasolabial sulcus received injection of cross-linked sodium hyaluronate gel without lidocaine for injection
Sponsors
Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age >=18 years old, regardless of gender; 2.Researchers have determined that bilateral nasolabial folds are moderate to severe (scored 3 to 4 on the Wrinkle Severity Scale) and have consistent scores on both sides, with the hope of improvement; 3.Agree not to perform any other cosmetic treatments on the face below the orbital margin during the trial period; 4.Voluntarily participate in the study and sign an informed consent form, fully understand the content, process, and possible adverse reactions of the trial, and agree to participate in treatment, visits, and examinations according to the requirements of the trial protocol.
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant or breastfeeding, or who plan to become pregnant during the trial period; 2. Individuals with severe psychiatric disorders, psychological disturbances, personality disorders, or those currently taking antipsychotic medication; 3. Acute exacerbations of allergic or inflammatory skin conditions on the face (e.g., dermatitis, eczema, acne, seborrhoeic dermatitis, rosacea), unhealed wounds, precancerous lesions, or malignancies; 4. Presence of systemic infection; 5. Coagulation disorders or use of anticoagulants or antiplatelet agents (e.g., aspirin, heparin, warfarin) within 2 weeks prior to injection; 6. History of severe disease affecting major organs (cardiovascular, pulmonary, hepatic, renal, or neurological systems) or history of immune dysfunction (e.g., autoimmune disorders, immunodeficiency); 7. History of hypertrophic scarring or keloids; 8. Allergy to hyaluronic acid or any component of this product, allergy to local anaesthetics (e.g., lidocaine or other amide-type anaesthetics), or history of severe or multiple allergic reactions; 9. Facial sensory abnormalities such as hypoesthesia, numbness, or neuralgia; 10. Structural asymmetry of the nasolabial folds; 11. Previous or planned treatment in the nasolabial fold or adjacent areas during the study period: - Previous fat grafting or implantation of permanent fillers such as polymethyl methacrylate, silicone, or polytetrafluoroethylene; Filling with semi-permanent fillers (e.g., hydroxyapatite, poly-L-lactic acid) within 36 months prior to enrolment; Filling with temporary fillers (e.g., hyaluronic acid) or undergoing facial wrinkle reduction procedures within 12 months prior to enrolment; Injection of botulinum toxin, collagen, or receipt of energy/radiofrequency treatments (e.g., Ultherapy, Thermage), lipolysis treatments (e.g., deoxycholic acid injections, cryolipolysis), or ablative treatments (e.g., ablative lasers, chemical peels) within 6 months prior to enrolment; Having undergone mesotherapy (e.g., hydrating injections, microneedling) or non-ablative laser treatments within 3 months prior to enrolment; 12. Having received any other investigational product within 30 days prior to enrolment or planning to participate in another clinical trial during the study period; 13. Presence of any other circumstances deemed by the investigator to render the subject unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of pain VAS score difference (control side - test side) = 10mm during injection process; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of pain VAS score difference (control side - test side) = 10mm during injection process;The overall beauty effect improvement efficiency evaluated by research participants; | — |
Countries
China
Contacts
Public ContactPeisheng Jin
Affiliated Hospital of Xuzhou Medical University
Outcome results
None listed