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

Launched by TAIPEI MEDICAL UNIVERSITY HOSPITAL · Aug 25, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at two different treatments for wrinkles that appear around the nose and mouth, known as nasolabial folds. The study compares a new treatment called PBF PLLA microspheres with an existing treatment called Sculptra®. About 50 people will participate, and each person will receive both treatments—one on each side of their face—so doctors can see which one works better.

To join the trial, participants need to be between 18 and 65 years old and have noticeable wrinkles on both sides of their face. They should not have had any recent cosmetic treatments in the area where the injections will occur or have certain health conditions that could complicate the treatment. If someone is eligible and decides to take part, they can expect to receive an injection of both treatments during their first visit, and then researchers will monitor the results. This study is currently active but not recruiting new participants.

Gender

ALL

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.