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

NCT02179606 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-07-08

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Across Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Beom Joon Kim, MD · Chung-Ang University Hosptial, Chung-Ang University College of Medicine

  • Jong Hoon Lee, MD · Eulji General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-03-31

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 NCT02179606 on ClinicalTrials.gov