NCT06013332

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

A Controlled, Randomized, Double-Blinded, Intra-Subject, Multicenter, Prospective, Clinical Study to Investigate the Non-Inferiority Between the Polymeric Microspheres and Sculptra® in the Treatment of Moderate to Severe Nasolabial Folds

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Taipei Medical University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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®

Timeline

• Start date: 2024-04-15
• Primary completion: 2025-09-01
• Completion: 2025-12-01
• First posted: 2023-08-28
• Last updated: 2024-07-03

Locations

2 sites across 1 country: Taiwan