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

Nasolabial Folds Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06216418
• Other study ID #: JWD-TH-01
• Status: Recruiting
• Phase: N/A
• Start date: February 29, 2024
• Est. completion date: October 30, 2025

Study information

• Verified date: January 2024
• Source: Hugel
• Contact: Cho Long Park
• Phone: +82-2-6966-1654
• Email: clpark[@]hugel.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: October 30, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nasolabial Folds

Intervention

Device:
• BRFS-18G-S100WH
A facial tissue fixation material made of polydioxanone (PDO).
• MINT Lift FINE+
A facial tissue fixation material made of polydioxanone (PDO).

Locations

Country	Name	City	State
Korea, Republic of	Hugel Inc.	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Hugel	Jworld

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline to week 4, 8, 24
Secondary	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.	Baseline to week 4, 8, 24
Secondary	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	Baseline to week 4, 8, 12, 24