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

A Single Center, Prospective, Comparative, Randomized, Double-blinded(Subject, Evaluator), Non-inferiority, Pivotal Clinical Study to Evaluate the Efficacy and Safety of the Polydioxanone Suture 'BRFS-18G-S100WH' Compared to 'MINT Lift FINE+' for Correction of the Nasolabial Folds

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06216418

Enrollment

106

Registered

2024-01-22

Start date

2024-02-29

Completion date

2025-10-30

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasolabial Folds

Brief summary

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

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.

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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

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

Design outcomes

Primary

Measure	Time frame	Description
Improvement rate (%) at 12 weeks after the procedure compared to baseline.	Baseline to week 12	Improvement rate (%) at 12 weeks after the procedure compared to baseline by an independent evaluator.

Secondary

Measure	Time frame	Description
WSRS evaluation by an independent evaluator	Baseline to week 4, 8, 24	Improvement rate (%): 4, 8, and 24 weeks after treatment. Baseline score change (points): 4, 8, 12, and 24 weeks after the procedure.
WSRS evaluation by tester	Baseline to week 4, 8, 24	Improvement rate (%): 4, 8, and 24 weeks after treatment. Baseline score change (points): 4, 8, 12, and 24 weeks after the procedure.
Satisfaction level (%) at 4, 8, 12, and 24 weeks after the procedure compared to the baseline.	Baseline to week 4, 8, 12, 24	Satisfaction level (%) at 4, 8, 12, and 24 weeks after the procedure compared to the baseline by the subject

Countries

South Korea

Contacts

Primary ContactCho Long Park

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026