Comparing two treatments for improving 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
This study is testing a new facial treatment to see if it can improve wrinkles around the mouth better than a current option for people with nasolabial folds.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 106 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Hugel Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06216418 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of a new facial tissue fixing material called 'BRFS-18G-S100WH' in comparison to the existing treatment 'MINT Lift FINE+' for patients with nasolabial folds. Participants will undergo a procedure aimed at temporarily improving the appearance of these wrinkles using the two different materials. The study aims to determine if 'BRFS-18G-S100WH' provides a similar or better wrinkle improvement effect while ensuring safety for the patients involved.
Who should consider this trial
Good fit: Ideal candidates are adults over 19 years old with moderate to severe nasolabial folds who wish to improve their appearance.
Not a fit: Patients who have previously undergone facial procedures using fillers or fixation threads may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer patients a new effective option for temporarily reducing nasolabial folds.
How similar studies have performed: While this approach is being tested in this specific context, similar studies have shown promising results with facial tissue lifting techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seoul
- Hugel Inc. — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Cho Long Park
- Email: clpark@hugel.co.kr
- Phone: +82-2-6966-1654
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.