NCT07150273

A Clinical Study to Evaluate the Efficacy and Safety of the Injection With UNIVELO Sub-Q, as Compared to Restylane® Sub-Q, in the Temporary Correction of the Nasolabial Fold

A Randomized, Single-Center, Patient & Evaluator-Blind, Matched Pairs, Active-Controlled Design Confirmatory Clinical Study to Evaluate the Efficacy and Safety of the Injection With UNIVELO Sub-Q, as Compared to Restylane® Sub-Q, in the Temporary Correction of the Nasolabial Fold

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Jetema Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

A 48-week, single-center, randomized, patient \& evaluator-blind, matched pairs, active-controlled, non-inferiority, confirmatory design

Conditions

• Nasolabial Fold

Interventions

Type	Name	Description
DEVICE	UNIVELO Sub-Q 2mL	Test device
DEVICE	Restylane Sub-Q 2mL	Comparator Device

Timeline

• Start date: 2016-02-23
• Primary completion: 2017-03-23
• Completion: 2017-07-28
• First posted: 2025-09-02
• Last updated: 2025-09-08