Clinical Trial

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

Unknown
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Record status
This record was last updated July 3, 2024 (before its estimated September 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 change
critical Trial status changed: Active, Not Recruiting → Unknown 2026-08-02
Trial Details
NCT Number NCT06013332
Lead Sponsor Taipei Medical University Hospital
Collaborators: Taipei Medical University, Panion & BF Biotech Inc.
Conditions Nasolabial Fold Wrinkles
Enrollment 50 participants
Start Date 2024-04-15
Primary Completion 2025-09 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2024-07-03