NCT06305520

Medical Device Pivotal Study to Injection With SkinPlus-HYAL Implant Lidocaine vs RESTYLANE Lidocaine in of Nasolabial Folds

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Bioplus · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

Purpose : This investigation intends to demonstrate that the investigational device, SkinPlus-HYAL Implant Lidocaine, is non-inferior to the comparator 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 with a multi-center, randomized, subject- \& evaluator-blind, matched pairs, active controlled, none-inferiority, confirmatory design Treatment Group: Application of the investigational medical device (SkinPlus-HYAL Implant Lidocaine) Control Group: Application of the comparator device (RESTYLANE Lidocaine) Population: Number of subject 100 \* In this investigation, the same subject receives both test and control treatments, one on each side of the nasolabial folds (matched pairs design).

Conditions

• Nasal Disease
• Nasal Surgery

Interventions

Type	Name	Description
DEVICE	Investigational medical device (SkinPlus-HYAL Implant Lidocaine)	\* In this investigation, the same subject receives both test and control treatments, one on each side of the nasolabial folds (matched pairs design).
DEVICE	Active Comparator: Active Comparator Medical Device (RESTYLANE Lidocaine)	\* In this investigation, the same subject receives both test and control treatments, one on each side of the nasolabial folds (matched pairs design).

Timeline

• Start date: 2023-03-10
• Primary completion: 2024-09-30
• Completion: 2024-10-31
• First posted: 2024-03-12
• Last updated: 2024-03-15

Locations

1 site across 1 country: South Korea