Polymeric Microspheres vs Sculptra® in the Treatment of Moderate to Severe Nasolabial Folds (NCT06013332) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Polymeric Microspheres vs Sculptra® in the Treatment of Moderate to Severe Nasolabial Folds
Taiwan50 participantsStarted 2024-04-15
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Participant whose age is ≥ 18 and ≤ 65 years old.
✓. Participant who is able to read, understand, sign, and date a written informed consent form (ICF) before study participation at screening.
✓. Participant is able to understand and comply with protocol requirements and instructions and likely to complete the study as planned.
✓. Participant who has moderate to severe nasolabial folds on two sides of face, WAS Score ≥ 3. WAS Score is determined by investigator.
✓. Participant whose difference in WAS score of nasolabial folds on two sides of face ≤ 1. WAS Score is determined by investigator.
✓. Participant's skin condition is considered by Investigator suitable for the treatment of Poly-L-lactic Acid (PLLA).
Exclusion criteria
✕. Treatment with collagen or hyaluronic acid (HA) in the last 12 months.
✕. Had facelift treatment (high intensity focused ultrasound, radio frequency, or thread) within 12 months.
What they're measuring
1
Delta of the WAS score between the Baseline and 26 weeks after treatment assessed by the Independent Evaluators of PLLA(PBF) versus Sculptra®