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RecruitingNCT06216418Updated Jan 22, 2024

Evaluate the Safety and Efficacy of 'BRFS-18G-S100WH' as Compared to 'MINT Lift FINE+' in Subject With Nasolabial Folds

An interventional study of BRFS-18G-S100WH and MINT Lift FINE+ in Nasolabial Folds, sponsored by Hugel. Recruiting at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-01-22.

Sponsored by Hugel · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
106
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

Evaluate the Safety and Efficacy of 'BRFS-18G-S100WH' as Compared to 'MINT Lift FINE+' in Subject With Nasolabial Folds.

Read the detailed description

This clinical trial was conducted on patients who wanted to improve both nasolabial folds through facial tissue lifting using facial tissue fixing material 'BRFS-18G-S100WH' made of polydioxanone (PDO). Compared to 'MINT Lift FINE+', we want to confirm whether it has a non-inferior temporary wrinkle improvement effect and can be safely applied to the human body.

02

Conditions studied

  • Nasolabial Folds
03

In context

Lead sponsor

Hugel is the lead sponsor of 16 studies on the registry; 2 are open to participants now.

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

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Adults over 19 years of age
  2. Those who wish to temporarily improve nasolabial folds on both sides of the face and have a score of 3 (Moderate) or 4 (Severe) on the WSRS (Wrinkle Severity Rating Scale)
  3. Those who voluntarily decided to participate in this clinical trial and agreed to the subject description and consent form in writing

Exclusion criteria

Exclusion Criteria:

  1. A person who has undergone a procedure using filler or facial tissue fixation thread on the facial area.
  2. Those who are pregnant or lactating
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
106 participants (estimated)

Study arms

  • Experimental
    BRFS-18G-S100WH

    Device: BRFS-18G-S100WH

  • Active comparator
    MINT Lift FINE+

    Device: MINT Lift FINE+

Interventions

  • DeviceBRFS-18G-S100WH

    A facial tissue fixation material made of polydioxanone (PDO).

  • DeviceMINT Lift FINE+

    A facial tissue fixation material made of polydioxanone (PDO).

06

What researchers measure

Primary outcomes

  1. Improvement rate (%) at 12 weeks after the procedure compared to baseline.

    Improvement rate (%) at 12 weeks after the procedure compared to baseline by an independent evaluator.

    Time frame: Baseline to week 12

Secondary outcomes

  1. WSRS evaluation by an independent evaluator

    Improvement rate (%): 4, 8, and 24 weeks after treatment. Baseline score change (points): 4, 8, 12, and 24 weeks after the procedure.

    Time frame: Baseline to week 4, 8, 24

  2. WSRS evaluation by tester

    Improvement rate (%): 4, 8, and 24 weeks after treatment. Baseline score change (points): 4, 8, 12, and 24 weeks after the procedure.

    Time frame: Baseline to week 4, 8, 24

  3. Satisfaction level (%) at 4, 8, 12, and 24 weeks after the procedure compared to the baseline.

    Satisfaction level (%) at 4, 8, 12, and 24 weeks after the procedure compared to the baseline by the subject

    Time frame: Baseline to week 4, 8, 12, 24

07

Study locations

1 of 1 sites recruiting
  • Hugel Inc.
    Seoul, Korea, Republic of
    Recruiting
    • ChoLong Park · Contact
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Feb 2024; primary completion for Jul 2025, 17 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 11, 2024
First posted
Jan 22, 2024
StartEst.
Feb 29, 2024
Primary completionEst.
Jul 31, 2025
CompletionEst.
Oct 30, 2025
Last update
Jan 22, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06216418
Lead sponsor
Hugel
Collaborators
Jworld
Responsible party
Sponsor
First posted
Jan 22, 2024
Start date
Feb 29, 2024 (estimated)
Primary completion
Jul 31, 2025 (estimated)
Completion
Oct 30, 2025 (estimated)
Last update
Jan 22, 2024

Study contacts

Cho Long Park
Contact
clpark@hugel.co.kr
+82-2-6966-1654

Oversight

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

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