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Pivotal Study to Evaluate the Efficacy and Safety of Injection With LASBEAU Strong in Correction of Nasolabial Folds

NCT06310863 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2024-03-15

No results posted yet for this study

Summary

Background: Nonsurgical injectable treatments have become popular for aesthetic purposes. In recent years, cross-linked hyaluronic acid (HA) fillers containing lidocaine have been used to correct the nasolabial folds.

Aim: The aim of this study was to demonstrate the efficacy and safety of a new HA filler (LASBEAU Strong) (24 mg/mL) compared with a conventional HA filler (Restylane Lyft) for the restoration of nasolabial folds.

Patients/methods: A total of 72 subjects were enrolled and randomized to receive injections of the new HA filler (test group) or the conventional HA filler (control group) on the left or right side of the face. The mean value difference in the Wrinkle Severity Rating Scale (WSRS) scores at week 24 evaluated primary efficacy. The WSRS and the Global Aesthetic Improvement Scale (GAIS) at weeks 8, 16, 24, and 48 evaluated secondary efficacy. Adverse events, laboratory tests, and a check of vital signs at every visit assessed safety.

Conditions

  • Dermal Fillers

Interventions

DEVICE

LASBEAU Strong or Restylane Lyft injection as hyaluronic acid fillers

Subjects will be randomized to receive LASBEAU Strong or Restylane Lyft injections into each of the nasolabial folds on both sides. LASBEAU Strong or Restylane Lyft Injection Box

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Chong Hyun Won, Doctor · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-07
Primary Completion
2020-11-24
Completion
2020-11-24

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06310863 on ClinicalTrials.gov