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 range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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®