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

Huons Co., Ltd.67 enrolled

Overview

* 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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Nasolabial FOLD

Interventions

HARA Filler(Hyaluronic acid Filler)

Eligibility

Sex: ALLMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Those who agreed to this treatment and signed the Informed Consent Form 2. Those who are 19 years old or more and desire to take correction of nasolabial folds 3. Those who have an intention of refraining from other cosmetic treatment(other filler injection, laser or chemical peeling, Botox injection or wrinkle reduction) during the clinical study period 4. Those whose Wrinkle Severity Rating Scale (WSRS) is more than 2 points at least Exclusion Criteria: 1. Those who are sensitive to lidocaine or other amide anesthesia 2. Those who are sensitive to control device 3. Those who are pregnant or lactating, or expect pregnancy 4. Those who are judged by the subinvestigator to be improper for this study

Outcomes

Primary Outcomes

Assessment By independent evaluator

Wrinkle Severity Rating Scale (WSRS, Wrinkle severity Rating scale) \* Grade 1: Absent, Grade 2: Mild, Grade 3: Moderate, Grade 4: Severe, Grade 5: Extereme

Time frame: Week 24 From baseline Visit(=Investigational Device Injection)