Moderate-to-severe nasolabial folds
Conditions
Interventions
Experimental group(Poly(p-dioxanone) Facial Filler):Surgical procedure
Control group (sodium hyaluronate gel for injection):Surgical procedure
Sponsors
West China Hospital of Stomatology, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–65 years (inclusive of both 18 and 65 years), regardless of gender; 2. Willing to undergo treatment for correction of nasolabial fold wrinkles; 3. As assessed by the investigator, bilateral nasolabial fold wrinkles are rated 3 or 4 on the Wrinkle Severity Rating Scale (WSRS); 4. Voluntarily signs the informed consent form, understands and accepts the study duration, and is able and willing to comply with all study requirements.
Exclusion criteria
Exclusion criteria: 1. Persons with active sinusitis; 2. Persons with tumors or precancerous lesions, active skin lesions (e.g., herpes), scars, or deformities in the nasolabial fold area; 3. Presence of unhealed wounds, acute or chronic skin diseases (e.g., infection or inflammation) in the treatment area; 4. Diagnosed with maxillary protrusion or descent of the mid-facial fat pad, which, in the investigator’s judgment, may affect efficacy evaluation; 5. Persons with active sepsis or autoimmune diseases (e.g., psoriasis); 6. Persons with a predisposition to scarring, prone to keloid or hypertrophic scar formation; 7. Diagnosed with mental illness or anxiety/depression in an active phase, unable to understand or comply with protocol requirements; 8. History of severe diseases of major organs or uncontrolled diabetes (fasting blood glucose > 9.0 mmol/L); 9. Persons with severe hepatic or renal insufficiency [liver function (ALT, AST) > 2× upper limit of normal (ULN); renal function (creatinine) > 1.5× ULN]; 10. Persons with a history of facial surgery or cosmetic procedures, or planning to undergo cosmetic treatments during the trial, meeting any of the following criteria: (1) In the nasolabial fold and/or mid-to-lower facial area, having undergone or planning to undergo during the study: fat injection, permanent implants/fillers (e.g., PMMA, silicone, or PTFE), or non-absorbable thread therapy; (2) In the nasolabial fold and/or mid-to-lower facial area, having undergone within 24 months before screening or planning to undergo during the study: semi-permanent dermal filler therapy (e.g., calcium hydroxylapatite, poly-L-lactic acid); (3) In the nasolabial fold and/or mid-to-lower facial area, having undergone within 12 months before screening or planning to undergo during the study: injectable biodegradable dermal fillers (e.g., cross-linked hyaluronic acid, collagen) or absorbable thread implantation; (4) Having undergone within 12 months before screening or planning to undergo during the study: facial rejuvenation surgery [e.g., endoscopic facelift, open facelift, short-scar facelift, minimally invasive facial suspension lift, canthoplasty, blepharoplasty via eyelid margin incision, lower eyelid blepharoplasty, mid-face lift]; (5) In the mid-to-lower facial area, having undergone within 6 months before screening or planning to undergo during the study: botulinum toxin injection, chemical peels, radiofrequency, ultrasound, laser, cryotherapy, mesotherapy; (6) In the facial area, having undergone within 3 months before screening or planning to undergo during the study: photorejuvenation therapy, intense pulsed light (IPL) treatment; 11. Persons with abnormal coagulation mechanisms (APTT > 1.5× ULN); those who have taken anticoagulants (e.g., warfarin, rivaroxaban), antiplatelet drugs (e.g., aspirin, clopidogrel), or injectable thrombolytics (e.g., recombinant human prourokinase) within 2 weeks before screening, or who may use such drugs during the trial; 12. Persons who have used topical agents [e.g., steroidal anti-inflammatory drugs, steroids (excluding cortisone), retinoids, etc.] in the mid-to-lower facial area within 1 month before screening, plan to use them during the trial, or are currently using cortisone medications (applies to medicinal products only, not cosmetics); 13. Persons who have used immunosuppressants, immunomodulatory therapies (e.g., monoclonal antibodies), or systemic corticosteroids (inhaled
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nasolabial Fold Wrinkle Correction Efficacy Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Nasolabial Fold Wrinkle Correction Efficacy Rate; | — |
Countries
China
Contacts
Public Contactwang hang
West China Hospital of Stomatology, Sichuan University
Outcome results
None listed