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Efficacy and Safety Study of Neuramis in Correction of Nasolabial Fold

NCT01585220 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2019-03-29

No results posted yet for this study

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

DEVICE

HA filler

The study device and comparator device will be intradermally injected to each left and right nasolabial fold according to the randomization.

Sponsors & Collaborators

  • Medy-Tox

    lead INDUSTRY

Principal Investigators

  • Chan Yeong Heo · Seoul National University Bundang Hospital

  • Saik Bang · Samsung Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-02-09
Primary Completion
2012-08-30
Completion
2012-10-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01585220 on ClinicalTrials.gov