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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04224649

Enrollment

Registered

2020-01-13

Start date

2019-04-23

Completion date

2020-07-30

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasolabial FOLD

Brief 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

Interventions

DEVICEHARA 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).

DEVICERestylane® Lidocaine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Assessment By independent evaluator	Week 24 From baseline Visit(=Investigational Device Injection)	Wrinkle Severity Rating Scale (WSRS, Wrinkle severity Rating scale) \* Grade 1: Absent, Grade 2: Mild, Grade 3: Moderate, Grade 4: Severe, Grade 5: Extereme

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026