NCT06216418

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 22, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

February 29, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

January 22, 2024

Status Verified

January 1, 2024

Enrollment Period

1.4 years

First QC Date

January 11, 2024

Last Update Submit

January 19, 2024

Conditions

Nasolabial Folds

Outcome Measures

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.

    Baseline to week 12

Secondary Outcomes (3)

  • WSRS evaluation by an independent evaluator

    Baseline to week 4, 8, 24

  • WSRS evaluation by tester

    Baseline to week 4, 8, 24

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

    Baseline to week 4, 8, 12, 24

Study Arms (2)

BRFS-18G-S100WH

EXPERIMENTAL
Device: BRFS-18G-S100WH

MINT Lift FINE+

ACTIVE COMPARATOR
Device: MINT Lift FINE+

Interventions

BRFS-18G-S100WHDEVICE

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

BRFS-18G-S100WH
MINT Lift FINE+DEVICE

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

MINT Lift FINE+

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults over 19 years of age
  • 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)
  • Those who voluntarily decided to participate in this clinical trial and agreed to the subject description and consent form in writing

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hugel Inc.

Seoul, South Korea

RECRUITING

Central Study Contacts

Cho Long Park

CONTACT

+82-2-6966-1654clpark@hugel.co.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2024

First Posted

January 22, 2024

Study Start

February 29, 2024

Primary Completion

July 31, 2025

Study Completion

October 30, 2025

Last Updated

January 22, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)