None
Conditions
Interventions
Control group:Subjects willing to correct nasolabial folds.
Investigational group:Subjects willing to correct nasolabial folds.
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
26 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Ages >= 26 (including 26 years old), male or female; 2.Subjects desiring to correct nasolabial folds; 3.Subjects with identical WSRS grades for bilateral nasolabial folds, with both being grade 3 or 4, as evaluated by blinded evaluators; 4.Subjects are able to understand the purpose of the trial, voluntarily participate in the trial and are willing to sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1.Subjects known to be allergic to hyaluronic acid products or any components of the investigational/control devices, or those with a history of severe allergic reactions or anaphylactic shock; 2.Subjects showing abnormal coagulation mechanism (activated partial thromboplastin time (APTT) >1.5 times the upper limit of normal) during the screening period, or those who have received any thrombolytic agent, anticoagulant or antiplatelet drugs (such as warfarin and aspirin) within 2 weeks before the screening; 3.Having tattoos, piercings, significant facial hair, scars, deformities, unhealed wounds, abscess, granuloma, active or persistent perinasal infection, cancers or precancerous lesions, malignant tumours or skin swellings with unknown nature, etc. in the injection and adjacent area that may affect the effectiveness evaluation or increase treatment-related risks; 4.Subjects presenting with active dermatological conditions or inflammations or infections (e.g., herpes, acne, eczema, dermatitis, psoriasis, herpes zoster, fungal infections, papillomatosis, etc.) that, in the investigator's judgment, may affect effectiveness evaluation or increase treatment risk; 5.Subjects who have previously undergone surgical procedures to improve facial wrinkles (such as autologous fat grafting, absorbable catgut embedding treatment, or face lift surgery, etc.) in or around the injection site within 12 months prior to screening, or those intending to undergo such treatments during the trial period, which, in the investigator's judgment, may affect effectiveness evaluation or increase treatment risk; 6.Subjects who have previously undergone any permanent filler treatments (e.g., polymethylmethacrylate, silicone, expanded polytetrafluoroethylene, etc.) or other unknown materials injection in or around the injection site, or those intending to undergo such treatments during the trial period; 7.Subjects who have received calcium hydroxylapatite, poly-L-lactic acid, polylactic acid, poly-D,L-lactic acid, poly-caprolactone, etc.) in or around the injection site within 24 months prior to screening, or those inending to undergo such treatments during the trial period; 8.Subjects who have previously undergone cross-linked hyaluronic acid sodium injection in or around the injection sites within 12 months prior to screening, or those intending to undergo such treatments during the trial period; 9.Subjects who have undergone any cosmetic treatments or facial surgeries (e.g., botulinum toxin treatment, non-crosslinked hyaluronic acid sodium filler, collagen filler, radiofrequency treatment, focused ultrasound treatment, photon, laser, medium or deeper chemical peels, dermabrasion, liposuction, lipolysis, photodynamic therapy or other ablative surgeries, etc. (except mesotherapy)) in the injection area and nearby regions within 6 months prior to screening, or those intending to undergo such treatments during the trial period; 10.Subjects who have undergone mesotherapy, photobiologic modulation therapy (red and blue light, etc., except laser therapy), intense pulsed light, microneedling (except radio frequency microneedles), very superficial or superficial chemical peels (e.g., retinol, glycolic acid, salicylic acid, etc.) treatments in the injection area and nearby regions within 3 months prior to screening, or those intending to undergo such treatments during the trial period; 11.Subjects with active autoimmune diseases (e.g., inflammatory bowel disease) or history
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Incidence of (serious) adverse events (%);Incidence of device defects (%);Subject satisfaction;Incidence of device-related (serious) adverse events (%);Effective rate of nasolabial folds improvement 180 days ±14 days after the last injection (evaluated by blinded researchers);Effective rate of improvement of nasolabial folds (Evaluation by treatment researchers);Evaluation of the overall aesthetic improvement effect (Evaluation by treatment researchers and subjects);Laboratory examination;Vital signs;Effective rate of improvement of nasolabial folds (evaluated by blinded researchers, excluding the evaluation time points of the main effectiveness evaluation indicators);Incidence of local reactions at the injection site (%); | — |
Countries
China
Contacts
Public ContactYan Wu
Peking University First Hospital
Outcome results
None listed