New wrinkle filler faces off against market leader in Split-Face trial

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Willing and able to provide written informed consent prior to any study-specific procedures. 2. Male or female subjects aged between 19 and 65 years. 3. Presence of bilateral nasolabial fold wrinkles with a Wrinkle Severity Rating Scale (WSRS) score of moderate (Grade 3) or severe (Grade 4) at baseline. 4. Willingness and ability to comply with all protocol-required follow-up visits and procedures. Exclusion Criteria: 1. History of hypertrophic scarring or keloid formation. 2. Presence of active infection or dermatologic conditions at or near the intended injection site that may interfere with the evaluation. 3. Underwent major surgery within 3 months prior to study initiation. 4. Diagnosed with autoimmune diseases, malignancies, psychiatric disorders, or poorly controlled chronic medical conditions. 5. Prior treatment with or planned use of permanent dermal fillers at the intended injection site. 6. Prior treatment with or planned use of temporary fillers, collagen stimulators, or thread lifting at the injection site within 12 months prior to screening or during the study period. 7. Underwent or plans to undergo laser treatments to the mid- or lower face within 3 months prior to treatment or during the study period. 8. Underwent or plans to undergo ultrasound or radiofrequency skin tightening procedures to the mid- or lower face within 6 months prior to treatment or during the study period. 9. Known hypersensitivity to poly-L-lactic acid or any components of the investigational device, or any other significant allergy as deemed by the investigator to pose risk to the subject. 10. Planned surgeries or medications during the study period that may cause significant weight changes. 11. Pregnant or breastfeeding women, or women intending to become pregnant during the study period. 12. Participation in another interventional clinical trial that has not concluded within 30 days prior to screening, or plans to participate in another interventional clinical study during the course of this study. 13. Any other condition or situation that, in the opinion of the investigator, renders the subject unsuitable for study participation.