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Clinical Study to Evaluate the Efficacy and Safety of Dermalax(Deep) in Correction of Nasolabial Folds

NCT02179619 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2014-07-02

No results posted yet for this study

Summary

The study is to verify that Dermalax (Deep) is not inferior to the reference device, Restylane®, in terms of efficacy and safety in the correction of nasolabial folds. 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 subject diary and follow up visits.

Conditions

  • Correction of Nasolabial Folds

Interventions

DEVICE

Dermalax(Deep)

Dermalax(Deep) injection into one nasolabial fold (NLF) of one side of the face (blinded, split-face study design) in the Initial Treatment period

DEVICE

Restylane

Restylane Injection into one nasolabial fold (NLF) 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, PhD · Chung-Ang University Hosptial, Chung-Ang University College of Medicine

  • Jong Hoon Lee, PhD · Eulji General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2014-01-31
Completion
2014-02-28

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 NCT02179619 on ClinicalTrials.gov