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Polymeric Microspheres vs Sculptra® in the Treatment of Moderate to Severe Nasolabial Folds

NCT06013332 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-07-03

No results posted yet for this study

Summary

This is a single-dose, randomized, double-blind, active-controlled, split-face, multiple centers, non-inferiority study. Approximately 50 nasolabial fold subjects will be enrolled. Each enrolled subject will be randomized equally into one of the following groups:

1. Group 1: right face will be injected with PBF PLLA microsphere, and left face with Sculptra®
2. Group 2: right face will be injected with Sculptra® and left face with PBF PLLA microsphere Subjects will be administrated on Visit 1 by applying PBF PLLA microsphere on one side of face and Sculptra® on the other.

Conditions

  • Nasolabial Fold Wrinkles

Interventions

DEVICE

PBF PLLA microsphere (injectable poly-L-lactic acid)

Poly-L-lactic acid (PLLA) is a collagen stimulator, helps restore the deep, underlying structure of the skin to diminish facial wrinkles. PLLA microparticles are absorbable for human body, and it works with human body within the deep dermis to help revitalize collagen production and help restore human skin's inner structure and volume. PLLA can rebuilt collagen strands begin gradually helping to restore facial volume and the look of fullness to wrinkles and folds.

DEVICE

Sculptra®

Sculptra®

Sponsors & Collaborators

  • Taipei Medical University

    collaborator OTHER

  • Panion & BF Biotech Inc.

    collaborator INDUSTRY

  • Taipei Medical University Hospital

    lead OTHER

Principal Investigators

  • Hsiou-Hsin Tsai, M.D. PhD. · Taipei Medical University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-15
Primary Completion
2025-09-30
Completion
2025-12-31

Countries

  • Taiwan

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 NCT06013332 on ClinicalTrials.gov