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Efficacy and Safety Study of Neuramis in Correction of Nasolabial Fold

Nasolabial Fold Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01585220
Study type Interventional
Source Medy-Tox
Contact
Status Completed
Phase Phase 3
Start date February 9, 2012
Completion date October 30, 2012
View Details
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