Effect of a New HA Filler in Correcting Nasolabial Fold

NCT ID: NCT06574750

Last Updated: 2024-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-16

Study Completion Date

2023-05-08

Brief Summary

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

Detailed Description

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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

Conditions

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Aging Problems

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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New HA filler (Curea)

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Juvederm

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

Group Type ACTIVE_COMPARATOR

JuvedermⓇ (Q-Med AB, Uppsala, Sweden)

Intervention Type DRUG

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

Interventions

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

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

Intervention Type DRUG

JuvedermⓇ (Q-Med AB, Uppsala, Sweden)

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

Intervention Type DRUG

Other Intervention Names

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experimental group active control group

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Bo Ri Kim

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bo Ri Kim, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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E-2105/684-001

Identifier Type: -

Identifier Source: org_study_id

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