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

NCT ID: NCT06013332

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-15
• Study Completion Date: 2025-12-31

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. 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.

Conditions

Nasolabial Fold Wrinkles

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group 1

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Sculptra®

Intervention Type: DEVICE

Sculptra®

Group 2

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Sculptra®

Intervention Type: DEVICE

Sculptra®

Interventions

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

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.

Intervention Type: DEVICE

Sculptra®

Sculptra®

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Participant whose age is ≥ 18 and ≤ 65 years old.

2. Participant who is able to read, understand, sign, and date a written informed consent form (ICF) before study participation at screening.

3. Participant is able to understand and comply with protocol requirements and instructions and likely to complete the study as planned.

4. Participant who has moderate to severe nasolabial folds on two sides of face, WAS Score ≥ 3. WAS Score is determined by investigator.

5. Participant whose difference in WAS score of nasolabial folds on two sides of face ≤ 1. WAS Score is determined by investigator.

6. Participant's skin condition is considered by Investigator suitable for the treatment of Poly-L-lactic Acid (PLLA).

Exclusion Criteria

-

1. Participant who has previous tissue augmenting therapy, contouring or revitalization treatment in or near the treatment area prior to the Baseline visit.

1. Treatment with collagen or hyaluronic acid (HA) in the last 12 months.

2. Had facelift treatment (high intensity focused ultrasound, radio frequency, or thread) within 12 months.

3. Had face laser treatment within 6 months.

4. Had been treated with Calcium Hydroxyapatite (CaHA), PLLA or permanent (non-biodegradable).

2. 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.

4. 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.

6. Participant who has serious systematic disease that judged by Investigator which is not suitable for the treatment.

7. 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.

8. Participant who previously had or have risks factors for hypertrophic scarring or keloid formation near the treatment area.

9. Participant who has used immune system suppression drugs, steroids, anti-inflammatory drugs, anticoagulant drugs, or aspirin within 7 days before treatment.

10. Female participant who is pregnant or lactating.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Taipei Medical University

OTHER

Sponsor Role: collaborator

Panion & BF Biotech Inc.

INDUSTRY

Sponsor Role: collaborator

Taipei Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hsiou-Hsin Tsai

Visiting Staff

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hsiou-Hsin Tsai, M.D. PhD.

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University Hospital

Locations

Taipei Medical University Hospital

Taipei, , Taiwan

Taipei Municipal Wanfang Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

PBF-PLLA-001

Identifier Type: -

Identifier Source: org_study_id