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

NCT06013332 | Active Not Recruiting DMC

• 1 other identifier: PBF-PLLA-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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:

1. 1.Group 1: right face will be injected with PBF PLLA microsphere, and left face with Sculptra®
2. 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.

Conditions

Nasolabial Fold Wrinkles

Outcome Measures

Primary Outcomes (1)

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

  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

  26 weeks

Secondary Outcomes (8)

• Overall operation time during subcutaneous injection of PLLA(PBF) versus Sculptra®

  First week from the Start of administration to the end of 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

• 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

• 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 WAS score compared to baseline assessed by the Investigator of PLLA(PBF) versus Sculptra®

  13th, 26th, 39th and 52nd week post-administration

Other Outcomes (3)

• Post injection treatment responses (From common treatment responses diary card) for safety evaluation of PBF PLLA microsphere versus Sculptra®

  During 2 weeks post-administration

• Assessment of injection site pain of PBF PLLA microsphere versus Sculptra® by using Visual Analogue Scale (VAS) score

  immediately after injection and at 5-, 15- and 30- minute post-administration

• Compare the treatment related adverse event

  During 52 weeks post-administration

Study Arms (2)

Group 1

EXPERIMENTAL

right face will be injected with PBF PLLA microsphere, and left face with Sculptra®

Device: PBF PLLA microsphere (injectable poly-L-lactic acid); Device: Sculptra®

Group 2

EXPERIMENTAL

right face will be injected with Sculptra® and left face with PBF PLLA microsphere

Device: PBF PLLA microsphere (injectable poly-L-lactic acid); Device: Sculptra®

Interventions

PBF PLLA microsphere (injectable poly-L-lactic acid) DEVICE

Poly-L-lactic acid (PLLA) is a collagen stimulator, helps restore the deep, underlying structure of the skin to diminish facial wrinkles. PLLA microparticles are absorbable for human body, and it works with human body within the deep dermis to help revitalize collagen production and help restore human skin's inner structure and volume. PLLA can rebuilt collagen strands begin gradually helping to restore facial volume and the look of fullness to wrinkles and folds.

Group 1; Group 2

Sculptra® DEVICE

Sculptra®

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• \. 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. 3. Participant who has obvious defects, trauma, or scars near the treatment area.
• \. Participant who has been diagnosed head cancer in the last 3 years. 5. 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.
• \. Participant who has connective tissue disease, bleeding disorders, active hepatitis, immune deficiency disease, disease such as cancer, stroke and/or myocardial infarction and on any immunosuppressive therapy.
• \. Participant who previously had or have risks factors for hypertrophic scarring or keloid formation near the treatment area.
• \. Participant who has used immune system suppression drugs, steroids, anti-inflammatory drugs, anticoagulant drugs, or aspirin within 7 days before treatment.
• \. Female participant who is pregnant or lactating.

Sponsors & Collaborators

• Taipei Medical University Hospital: lead
• Taipei Medical University: collaborator
• Panion & BF Biotech Inc.: collaborator

Study Sites (2)

Taipei Medical University Hospital

Taipei, Taiwan

Location

Taipei Municipal Wanfang Hospital

Taipei, Taiwan

Location

Study Officials

• Hsiou-Hsin Tsai, M.D. PhD.

  Taipei Medical University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Visiting Staff

Study Record Dates

• First Submitted: August 13, 2023
• First Posted: August 28, 2023
• Study Start: April 15, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 3, 2024

Record last verified: 2024-07

Locations

TW (2)