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

Taipei Medical University Hospital2 sites in 1 country50 target enrollmentApril 15, 2024

ConditionsNasolabial Fold Wrinkles

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Nasolabial Fold Wrinkles
Sponsor: Taipei Medical University Hospital
Enrollment: 50
Locations: 2
Primary Endpoint: Delta of the WAS score between the Baseline and 26 weeks after treatment assessed by the Independent Evaluators of PLLA(PBF) versus Sculptra®
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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:

Group 1: right face will be injected with PBF PLLA microsphere, and left face with Sculptra®
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.

Registry

clinicaltrials.gov

Start Date

April 15, 2024

End Date

December 2025

Last Updated

last year

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Taipei Medical University Hospital

Responsible Party

Principal Investigator

Hsiou-Hsin Tsai

Visiting Staff

Taipei Medical University Hospital

Eligibility Criteria

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 ≥
•WAS Score is determined by investigator.
•Participant whose difference in WAS score of nasolabial folds on two sides of face ≤
•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

•Participant who has previous tissue augmenting therapy, contouring or revitalization treatment in or near the treatment area prior to the Baseline visit.
•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.
•Had face laser treatment within 6 months.
•Had been treated with Calcium Hydroxyapatite (CaHA), PLLA or permanent (non-biodegradable).
•Participant who has severe allergies with a history of severe reactions (anaphylaxis) or multiple severe allergies or has known/previous allergy or hypersensitivity to any of the PLLA, other constituents of PBF PLLA microsphere or Sculptra®, or drugs containing lidocaine such as Lidiprine Cream and its constituents.
•Participant who has obvious defects, trauma, or scars near the treatment area.
•Participant who has been diagnosed head cancer in the last 3 years.
•Participant who has trauma, open wound, active skin disease or inflammation at the injection site.
•Participant who has serious systematic disease that judged by Investigator which is not suitable for the treatment.

Outcomes

Primary Outcomes

Delta of the WAS score between the Baseline and 26 weeks after treatment assessed by the Independent Evaluators of PLLA(PBF) versus Sculptra®

Time Frame: 26 weeks

Wrinkle Assessment Scale (WAS): 0 No wrinkles; 1 Just perceptible wrinkle; 2 Shallow wrinkles; 3 Moderately deep wrinkle; 4 deep wrinkle, well-defined edges; 5 Very deep wrinkle, redundant fold

Secondary Outcomes

Overall operation time during subcutaneous injection of PLLA(PBF) versus Sculptra®(First week from the Start of administration to the end of administration)
Number of subjects scored either 'Much Improved' or 'Improved' on GAIS evaluated by the Investigator for PLLA(PBF) versus Sculptra®(13th, 26th, 39th and 52nd week post-administration)
Delta of the WAS score assessed by the Investigator between each follow-up visit (13th, 26th, 39th and 52nd week post-administration) and the Baseline of PLLA(PBF) versus Sculptra®(13th, 26th, 39th and 52nd week post-administration)
Subject's satisfaction score (Subjective 5-point scale with 1 being 'very satisfied' and 5 being 'very dissatisfied') of PLLA(PBF) versus Sculptra®(13th, 26th, 39th and 52nd week post-administration)
Delta of the WSRS score between the Baseline and 26 weeks after treatment assessed by the Independent Evaluators of PLLA(PBF) versus Sculptra®(26 weeks)
Percentage of responders based on the intra-individual improvement of at least one grade in the WAS score compared to baseline assessed by the Investigator of PLLA(PBF) versus Sculptra®(13th, 26th, 39th and 52nd week post-administration)
Delta of the WSRS score assessed by the Investigator between each follow-up visit (13th, 26th, 39th and 52nd week post-administration) and the Baseline of PLLA(PBF) versus Sculptra®(13th, 26th, 39th and 52nd week post-administration)
Percentage of responders based on the intra-individual improvement of at least one grade in the WSRS score compared to baseline assessed by the Investigator of PLLA(PBF) versus Sculptra®(13th, 26th, 39th and 52nd week post-administration)