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CompletedNCT06574750Updated Aug 28, 2024

Effect of a New HA Filler in Correcting Nasolabial Fold

An interventional study of CUREAⓇ (ARIBIO, Ltd., Seoul, Republic of Korea) and JuvedermⓇ (Q-Med AB, Uppsala, Sweden) in Aging Problems, sponsored by Seoul National University Bundang Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-28.

Sponsored by Seoul National University Bundang Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 10 months after the study started (first participant enrolled Oct 2021, registered Aug 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
74
Allocation
Randomized
Ages
30 Years to 65 Years
Sex
All
01

Study summary

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

Read the detailed 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

02

Conditions studied

  • Aging Problems
03

In context

Lead sponsor

Seoul National University Bundang Hospital is the lead sponsor of 368 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patients who had prominent NLFs with a WSRS score of 3 or 4 on both sides

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
74 participants (actual)

Study arms

  • Experimental
    New HA filler (Curea)

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

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

  • Active comparator
    Juvederm

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

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

Interventions

  • DrugCUREAⓇ (ARIBIO, Ltd., Seoul, Republic of Korea)

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

    Also known as: experimental group

  • DrugJuvedermⓇ (Q-Med AB, Uppsala, Sweden)

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

    Also known as: active control group

06

What researchers measure

Primary outcomes

  1. 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

  1. GAIS

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

    Time frame: at 24 weeks after treatment

  2. Adverse events related to the procedure

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

    Time frame: up to 24 weeks

07

Study locations

1 site
  • Seoul National University Bundang Hospital
    Seongnam, 13620, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06574750
Lead sponsor
Seoul National University Bundang Hospital
Responsible party
Bo Ri Kim (Assistant professor, Seoul National University Bundang Hospital) — Principal investigator
First posted
Aug 28, 2024
Start date
Oct 16, 2021
Primary completion
May 8, 2023
Completion
May 8, 2023
Last update
Aug 28, 2024

Study contacts

Bo Ri Kim, M.D., Ph.D.
principal investigator · Seoul National University Bundang Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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