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

Hugel

Status: Enrolling

Conditions: Nasolabial Folds

Treatments: Device: BRFS-18G-S100WH; Device: MINT Lift FINE+

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06216418

JWD-TH-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 106 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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106 participants in 2 patient groups

BRFS-18G-S100WH

Experimental group

Treatment:

Device: BRFS-18G-S100WH

MINT Lift FINE+

Active Comparator group

Treatment:

Device: MINT Lift FINE+