moderate to severe nasolabial fold wrinkles
Conditions
Interventions
Control Group:Administered with modified sodium hyaluronate gel for injection.
Experimental Group:Medical device used in the test group: Composite microspheres facial filler
Sponsors
West China Hospital of Stomatology, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years (inclusive of 18 and 75 years of age), regardless of gender; 2. Subjects willing to receive treatment for correcting nasolabial fold wrinkles; 3. Subjects with a blinded investigator (on-site) assessment of bilateral nasolabial fold WSRS score of 3 or 4; 4. Study participants voluntarily participate in the clinical trial, are willing and able to undergo treatment and follow-up observations as required, and have signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Individuals with hypersensitivity to polycaprolactone-co-lactide, hydroxyapatite, sodium carboxymethylcellulose, sodium hyaluronate, or any other ingredient in the product, or hypersensitivity to any local anesthetic (e.g., lidocaine or other amide-type anesthetics), or those with a history of severe allergic reactions or multiple severe allergies; 2. Presence of conditions in the treatment area that may affect treatment and efficacy evaluation, such as scars, active inflammation, infection, malignant or premalignant lesions, unhealed wounds, etc. 3. Pregnant or lactating individuals, or those unwilling to use medically acceptable contraceptive measures during the trial period; 4. Individuals with a history of surgery or aesthetic treatment in the nasolabial folds and/or mid-lower face, or who plan to undergo aesthetic treatment during the trial, meeting any of the following criteria: a) Previous treatment with implants or permanent fillers (e.g., polymethyl methacrylate, etc.); b) Treatment with semi-permanent dermal fillers (e.g., hydroxyapatite, poly-L-lactic acid, polycaprolactone, etc.) within 12 months prior to screening; c) Treatment with temporary dermal fillers (e.g., sodium hyaluronate, collagen) within 6 months prior to screening; d) Rhytidectomy within 12 months prior to screening; e) Botulinum toxin injection, mesotherapy, energy-based device treatment (ultrasound, radiofrequency, laser, etc.), or chemical peeling within 6 months prior to screening; 5. Use of topical glucocorticoids (regardless of potency), retinoids, retinol-like agents, or other topical medications (pharmaceuticals only) that may affect trial evaluations on the mid-lower face within 3 months prior to screening; or individuals planning to use such medications on any body region during the trial; 6. Individuals with abnormal coagulation function (e.g., activated partial thromboplastin time > 1.5 × upper limit of normal); oral administration of anticoagulants (e.g., warfarin, rivaroxaban, etc.), antiplatelet agents (e.g., aspirin, clopidogrel, etc.), or thrombolytic injections (e.g., recombinant human prourokinase, etc.) within 2 weeks prior to screening, or those unwilling or unable to discontinue these medications during the trial; 7. Individuals undergoing or planning to undergo orthodontic treatment during the trial; 8. Liver function (alanine aminotransferase, aspartate aminotransferase) > 2 × upper limit of normal; renal function (creatinine) > 1.5 × upper limit of normal; 9. Individuals with active sinusitis; 10. Individuals with active sepsis or autoimmune diseases (e.g., psoriasis, etc.); 11. Individuals with a history of keloids, hypertrophic scars, or scar diathesis; 12. Individuals with severe psychiatric disorders or emotional instability who are unable to understand and comply with protocol requirements; 13. Individuals with excessively high expectations for treatment outcomes or those unable to accept any transient adverse reactions such as bruising, swelling, or pain that may occur after treatment; 14. Individuals undergoing radiotherapy or chemotherapy; 15. Participation in any other interventional clinical trial within 3 months prior to screening; 16. Any other conditions deemed inappropriate for participation in this trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy rate of wrinkle correction at 48 weeks after the last injection; | — |
Secondary
| Measure | Time frame |
|---|---|
| Effective Rate of Wrinkle Correction;Wrinkle Severity Rating Scale, WSRS;Global Aesthetic Improvement Scale, GAIS;Pain Score; | — |
Countries
China
Contacts
Public ContactWang Hang
West China Hospital of Stomatology, Sichuan University
Outcome results
None listed