Effect of a New HA Filler in Correcting Nasolabial Fold

Seoul National University Bundang Hospital74 enrolled

Overview

The investigators aimed to evaluate the efficacy and safety of new HA filler for nasolabial fold correction

A 24-week prospective, single-center, assessor-blinded, randomized, split-face study was conducted to compare the clinical efficacy and safety of new HA filler versus Juvederm for nasolabial fold correction

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Aging Problems

Interventions

CUREAⓇ (ARIBIO, Ltd., Seoul, Republic of Korea)DRUG

Hyaluronic acid filler injection were administered into the mid-dermis of the nasolabial fold.

JuvedermⓇ (Q-Med AB, Uppsala, Sweden)DRUG

Hyaluronic acid filler injection were administered into the mid-dermis of the nasolabial fold.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who had prominent NLFs with a WSRS score of 3 or 4 on both sides Exclusion Criteria: * patients with active facial skin diseases or history of severe allergies, autoimmune disorders, or hypersensitivity to HA or any of the excipients contained in the investigational filler * participants who had used a local topical preparation (steroid and retinoid) within 2 weeks before the study * participants who had undergone chemical peeling, laser procedures, or acne treatments within 4 months before the study * participants who had been injected with other biomaterials, including HA within 6 months before the study.

Locations (1)

Seoul National University Bundang Hospital

Seongnam, South Korea

Outcomes

Primary Outcomes

WSRS

Wrinkle Severity Rating Scale from 1 (no visible fold) to 5 (extremely deep and long folds)

Time frame: at 24 weeks after treatment

Secondary Outcomes

GAIS

Global Aesthetic Improvement Scale from 3 (very much improved) to -1 (worse).

Time frame: at 24 weeks after treatment

Adverse events related to the procedure

Patients were required to report any adverse events up to 24 weeks

Time frame: up to 24 weeks

Data from ClinicalTrials.gov

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