Clinical trial NCT06013332: Polymeric Microspheres vs Sculptra® in the Treatment of Moderate to Severe Nasolabial Folds
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Nasolabial Fold Wrinkles
Lead sponsor: Taipei Medical University Hospital
Sponsor class: OTHER
Collaborators: name: Taipei Medical University
name: Panion & BF Biotech Inc.
First posted: 2023-08-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Delta of the WAS score between the Baseline and 26 weeks after treatment assessed by the Independent Evaluators of PLLA(PBF) versus Sculptra®
timeFrame: 26 weeks
Secondary outcomes:
measure: Overall operation time during subcutaneous injection of PLLA(PBF) versus Sculptra®
timeFrame: First week from the Start of administration to the end of administration
measure: 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®
timeFrame: 13th, 26th, 39th and 52nd week post-administration
measure: Delta of the WSRS score between the Baseline and 26 weeks after treatment assessed by the Independent Evaluators of PLLA(PBF) versus Sculptra®
timeFrame: 26 weeks
measure: 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®
timeFrame: 13th, 26th, 39th and 52nd week post-administration
measure: 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®
timeFrame: 13th, 26th, 39th and 52nd week post-administration
measure: 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®
timeFrame: 13th, 26th, 39th and 52nd week post-administration
measure: Number of subjects scored either 'Much Improved' or 'Improved' on GAIS evaluated by the Investigator for PLLA(PBF) versus Sculptra®
timeFrame: 13th, 26th, 39th and 52nd week post-administration
measure: Subject's satisfaction score (Subjective 5-point scale with 1 being 'very satisfied' and 5 being 'very dissatisfied') of PLLA(PBF) versus Sculptra®
timeFrame: 13th, 26th, 39th and 52nd week post-administration
Other outcomes:
measure: Post injection treatment responses (From common treatment responses diary card) for safety evaluation of PBF PLLA microsphere versus Sculptra®
timeFrame: During 2 weeks post-administration
measure: Assessment of injection site pain of PBF PLLA microsphere versus Sculptra® by using Visual Analogue Scale (VAS) score
timeFrame: immediately after injection and at 5-, 15- and 30- minute post-administration
measure: Compare the treatment related adverse event
timeFrame: During 52 weeks post-administration
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
city: Taipei
country: Taiwan
facility: Taipei Municipal Wanfang Hospital
Study officials:
affiliation: Taipei Medical University Hospital
name: Hsiou-Hsin Tsai, M.D. PhD.
role: PRINCIPAL_INVESTIGATOR
References: