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OpenTrials
Completed

NCT Number: NCT06574750

Effect of a New HA Filler in Correcting Nasolabial Fold

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

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Key information

Conditions

Aging Problems

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam, 13620, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

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

Other names: experimental group

JuvedermⓇ (Q-Med AB, Uppsala, Sweden)

Drug

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

Other names: active control group

Primary outcomes

  1. WSRS

    Time frame: at 24 weeks after treatment

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

Secondary outcomes

  1. GAIS

    Time frame: at 24 weeks after treatment

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

  2. Adverse events related to the procedure

    Time frame: up to 24 weeks

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

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

New HA Filler Versus Juvederm for Nasolabial Fold Correction

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 28, 2024
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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