Medical Device Pivotal Study to Injection With SkinPlus-HYAL Implant Lidocaine vs RESTYLANE Lidocaine in of Nasolabial Folds — BPLUS-02  

Nasal Surgery Clinical Trial

Official title: 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 Enrolling by invitation

Clinical Trial 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).

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Nasal Disease
• Nasal Surgery
• Nose Diseases

• NCT number: NCT06305520
• Study type: Interventional
• Source: Bioplus
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 10, 2023
• Completion date: October 31, 2024