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

Huons

Status: Unknown

Conditions: Nasolabial FOLD

Treatments: Device: Restylane® Lidocaine; Device: HARA Filler(Hyaluronic acid Filler)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04224649

HU-055

Details and patient eligibility

About

• 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

Enrollment: 67 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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67 participants in 2 patient groups

Test Device Group(HARA filler)

Experimental group

Treatment:

Device: HARA Filler(Hyaluronic acid Filler)

Comparator Group(Restylane® Lidocaine)

Active Comparator group

Treatment:

Device: Restylane® Lidocaine