NCT02179606

Clinical Study to Evaluate the Efficacy and Safety of Dermalax Implant Plus

A Multi-Center, Randomized, Subject and Evaluator Blind, Split-Face Comparative Medical Device Clinical Study to Evaluate the Efficacy and Safety of Dermalax Implant Plus to Restylane® Sub-Q for Correction of Nasolabial Folds

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Across Co., Ltd. · Industry
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This study is to verify that Dermalax Implant Plus is not inferior to the reference device, Restylane® Sub-Q, in terms of efficacy and safety in the correction of nasolabial folds

Conditions

• Correction of Nasolabial Folds

Interventions

Type	Name	Description
DEVICE	Dermalax Implant Plus	Dermalax implant plus injection into one nasolabial fold(NFL) of one side of the face(blinded, split-face study design) in the initial treatment period.
DEVICE	Restylane Sub-Q	Restylane Sub-Q injection into one nasolabial fold(NFL) of one side of the face(blinded, split-face study design) in the initial treatment period.

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-03-01
• First posted: 2014-07-02
• Last updated: 2014-07-08

Locations

2 sites across 1 country: South Korea