Clinical Trial: Medical Device Pivotal Study to Evaluate the Efficacy and Safety of Injection With SkinPlus-HYAL Implant Lidocaine as Compared to RESTYLANE Lidocaine in Temporary Correction of Nasolabial Folds

U.S., March 12 -- ClinicalTrials.gov registry received information related to the study (NCT06305520) titled 'Medical Device Pivotal Study to Evaluate the Efficacy and Safety of Injection With SkinPlus-HYAL Implant Lidocaine as Compared to RESTYLANE Lidocaine in Temporary Correction of Nasolabial Folds' on March 1.

Brief Summary: Purpose : This investigation intends to demonstrate that the investigational device, SkinPlus-HYAL Implant Lidocaine, is non-inferior to the control device, RESTYLANE Lidocaine, in terms of temporary wrinkle reduction effect, safety, and injection site pain when applied on nasolabial folds in adults.

Design : 24-week efficacy and safety evaluation and additional 48-week long-term safety and efficacy evaluation wi...