NCT04224649

To Evaluate the Efficacy and Safety of Injection With HARA as Compared to Restylane® Lidocaine in Temporary Correction of Nasolabial Folds

A Single Center, Randomized, Subject & Evaluator-blind, Matched Pairs, Active-controlled Design Pivotal Study to Evaluate the Efficacy and Safety of Injection With HARA as Compared to Restylane® Lidocaine in Temporary Correction of Nasolabial Folds

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 67 (estimated)
• Sponsor: Huons Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

* Investigational Device : HARA (Hyaluronic Acid Filler) * Title : A Single center, Randomized, Subject \& Evaluator-blind, Matched pairs, Active-controlled design Pivotal study to Evaluate the Efficacy and Safety of Injection with HARA as Compared to Restylane® Lidocaine in temporary Correction of Nasolabial folds * Sites and investigators : Chung-ang University Hospital(Seoul), Beom-Joon Kim, M.D, Ph.D * Objective : To compare the non-inferiority of HARA with Restylane® Lidocaine for evaluation of the efficacy and safety on Nasolabial Folds

Conditions

• Nasolabial FOLD

Interventions

Type	Name	Description
DEVICE	HARA Filler(Hyaluronic acid Filler)	The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).
DEVICE	Restylane® Lidocaine	The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).

Timeline

• Start date: 2019-04-23
• Primary completion: 2020-01-30
• Completion: 2020-07-30
• First posted: 2020-01-13
• Last updated: 2020-01-13

Locations

1 site across 1 country: South Korea