Effect of a New HA Filler in Correcting Nasolabial Fold

Seoul National University

Status: Completed

Conditions: Aging Problems

Treatments: Drug: JuvedermⓇ (Q-Med AB, Uppsala, Sweden); Drug: CUREAⓇ (ARIBIO, Ltd., Seoul, Republic of Korea)

Study type: Interventional

Funder types: Other

Identifiers

NCT06574750

E-2105/684-001

Details and patient eligibility

About

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

Full description

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

Enrollment: 74 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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74 participants in 2 patient groups

New HA filler (Curea)

Experimental group

Description:

The left/right assignment was sealed in a nontransparent envelop.

Treatment:

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

Juvederm

Active Comparator group

Description:

The left/right assignment was sealed in a nontransparent envelop.

Treatment:

Drug: JuvedermⓇ (Q-Med AB, Uppsala, Sweden)