NCT01585220

Efficacy and Safety Study of Neuramis in Correction of Nasolabial Fold

A Randomized, Multi-center, Double Masked, Matched Pairs, Active-controlled Clinical Trial to Evaluate the Efficacy and Safety of Injection With Neuramis as Compared to Restylane® in Correction of Nasolabial Fold

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Medy-Tox · Industry
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This study design is a randomized, multi-center, double Masked, matched Pairs, active-controlled clinical trial. Subjects who voluntarily signed the informed consent and are judged to be eligible for this study will be intradermally injected both of study device and comparator device. Subjects will be randomized to receive injection of study device and comparator device on their each nasolabial fold. Efficacy is evaluated based on the change in Wrinkle Severity Rating Scale (WSRS) from baseline. Safety will be assessed based on 24 weeks follow up visits and subject diary which will be given to subjects during the first 2 weeks after the injection. Any uncomfortable things and adverse events will be investigated from subeject diary and follow up visits.

Conditions

• Nasolabial Fold

Interventions

Type	Name	Description
DEVICE	HA filler	The study device and comparator device will be intradermally injected to each left and right nasolabial fold according to the randomization.

Timeline

• Start date: 2012-02-09
• Primary completion: 2012-08-30
• Completion: 2012-10-30
• First posted: 2012-04-25
• Last updated: 2019-03-29

Locations

2 sites across 1 country: South Korea