Status:
ACTIVE_NOT_RECRUITING
Polymeric Microspheres vs Sculptra® in the Treatment of Moderate to Severe Nasolabial Folds
Lead Sponsor:
Taipei Medical University Hospital
Collaborating Sponsors:
Taipei Medical University
Panion & BF Biotech Inc.
Conditions:
Nasolabial Fold Wrinkles
Eligibility:
All Genders
18-65 years
Phase:
NA
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 subje...
Eligibility Criteria
Inclusion
- 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
- \-
- 1\. 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).
- 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.
Key Trial Info
Start Date :
April 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06013332
Start Date
April 15 2024
End Date
December 1 2025
Last Update
July 3 2024
Active Locations (2)
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1
Taipei Medical University Hospital
Taipei, Taiwan
2
Taipei Municipal Wanfang Hospital
Taipei, Taiwan