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

January 19, 2024 updated by: Hugel

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Hugel Inc.
        • Contact:
          • ChoLong Park

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BRFS-18G-S100WH
Device: BRFS-18G-S100WH
A facial tissue fixation material made of polydioxanone (PDO).
Active Comparator: MINT Lift FINE+
Device: MINT Lift FINE+
A facial tissue fixation material made of polydioxanone (PDO).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WSRS evaluation by an independent evaluator
Time Frame: 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.
Baseline to week 4, 8, 24
WSRS evaluation by tester
Time Frame: 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.
Baseline to week 4, 8, 24
Satisfaction level (%) at 4, 8, 12, and 24 weeks after the procedure compared to the baseline.
Time Frame: 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
Baseline to week 4, 8, 12, 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hugel

Collaborators

Jworld

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 29, 2024

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

October 30, 2025

Study Registration Dates

First Submitted

January 11, 2024

First Submitted That Met QC Criteria

January 19, 2024

First Posted (Actual)

January 22, 2024

Study Record Updates

Last Update Posted (Actual)

January 22, 2024

Last Update Submitted That Met QC Criteria

January 19, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • JWD-TH-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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