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To Evaluate the Efficacy and Safety of Injection With HARA as Compared to Restylane® Lidocaine in Temporary Correction of Nasolabial Folds

NCT04224649 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2020-01-13

No results posted yet for this study

Summary

* Investigational Device : HARA (Hyaluronic Acid Filler)
* Title : A Single center, Randomized, Subject \& Evaluator-blind, Matched pairs, Active-controlled design Pivotal study to Evaluate the Efficacy and Safety of Injection with HARA as Compared to Restylane® Lidocaine in temporary Correction of Nasolabial folds
* Sites and investigators : Chung-ang University Hospital(Seoul), Beom-Joon Kim, M.D, Ph.D
* Objective : To compare the non-inferiority of HARA with Restylane® Lidocaine for evaluation of the efficacy and safety on Nasolabial Folds

Conditions

  • Nasolabial FOLD

Interventions

DEVICE

HARA Filler(Hyaluronic acid Filler)

The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).

DEVICE

Restylane® Lidocaine

The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).

Sponsors & Collaborators

  • Humedix Co., Ltd.

    collaborator INDUSTRY

  • Huons Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-23
Primary Completion
2020-01-30
Completion
2020-07-30

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 NCT04224649 on ClinicalTrials.gov