NCT06216418

Evaluate the Safety and Efficacy of 'BRFS-18G-S100WH' as Compared to 'MINT Lift FINE+' in Subject With Nasolabial Folds

A Single Center, Prospective, Comparative, Randomized, Double-blinded(Subject, Evaluator), Non-inferiority, Pivotal Clinical Study to Evaluate the Efficacy and Safety of the Polydioxanone Suture 'BRFS-18G-S100WH' Compared to 'MINT Lift FINE+' for Correction of the Nasolabial Folds

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (estimated)
• Sponsor: Hugel · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the Safety and Efficacy of 'BRFS-18G-S100WH' as Compared to 'MINT Lift FINE+' in Subject With Nasolabial Folds.

Detailed description

This clinical trial was conducted on patients who wanted to improve both nasolabial folds through facial tissue lifting using facial tissue fixing material 'BRFS-18G-S100WH' made of polydioxanone (PDO). Compared to 'MINT Lift FINE+', we want to confirm whether it has a non-inferior temporary wrinkle improvement effect and can be safely applied to the human body.

Conditions

• Nasolabial Folds

Interventions

Type	Name	Description
DEVICE	BRFS-18G-S100WH	A facial tissue fixation material made of polydioxanone (PDO).
DEVICE	MINT Lift FINE+	A facial tissue fixation material made of polydioxanone (PDO).

Timeline

• Start date: 2024-02-29
• Primary completion: 2025-07-31
• Completion: 2025-10-30
• First posted: 2024-01-22
• Last updated: 2024-01-22

Locations

1 site across 1 country: South Korea