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

Nasolabial Fold Wrinkles Clinical Trial

Official title: 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 Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Nasolabial Fold Wrinkles

• NCT number: NCT06013332
• Study type: Interventional
• Source: Taipei Medical University Hospital
• Contact: Hsiou-Hsin Tsai, M.D. PhD.
• Phone: +886-2-2737-2181
• Email: tsaihh2000@yahoo.com.tw
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2024
• Completion date: December 2025