Nasolabial Fold WrinklesNCT06013332
Polymeric Microspheres vs Sculptra® in the Treatment of Moderate to Severe Nasolabial Folds
A study testing PBF PLLA microsphere (injectable poly-L-lactic acid) and Sculptra® in people with Nasolabial Fold Wrinkles, run by Taipei Medical University Hospital at 2 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasolabial Fold Wrinkles
- What is being tested?
- PBF PLLA microsphere (injectable poly-L-lactic acid) and Sculptra®
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesTaiwan
- Study dates
- 15 Apr 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- -
- 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).
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- 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.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Taipei Medical University Hospital
Taipei
Taipei Municipal Wanfang Hospital
Taipei
About this study
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
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:
- Group 1: right face will be injected with PBF PLLA microsphere, and left face with Sculptra®
- 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
- Being tested
- PBF PLLA microsphere (injectable poly-L-lactic acid), Sculptra®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Sculptra®Device
Sculptra®
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | right face will be injected with PBF PLLA microsphere, and left face with Sculptra® Receives: 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 Receives: Device: PBF PLLA microsphere (injectable poly-L-lactic acid); Device: Sculptra® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 26 weeks
Secondary outcomes (8)
Overall operation time during subcutaneous injection of PLLA(PBF) versus Sculptra®
To compare the operational smoothness for physicians between the two medical devices
Measured: 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®
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
Measured: 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®
Grade 1: No visible nasolabial fold; continuous skin line Grade 2: Shallow but visible nasolabial fold with a slight indentation; minor facial feature; the implant is expected to produce a slight improvement in appearance Grade 3: Moderately deep nasolabial folds; clear facial feature visible at normal appearance but not when stretched; excellent correction is expected with injectable implant Grade 4: Very long and deep nasolabial folds; prominent facial feature; 2mm visible fold when stretched; significant improvement is expected with injectable implant Grade 5: Extremely deep and long nasolabial folds, detrimental to facial appearance; 2-4mm visible V-shaped fold when stretched; unlikely to have satisfactory correction with injectable implant alone
Measured: 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®
Grade 1: No visible nasolabial fold; continuous skin line Grade 2: Shallow but visible nasolabial fold with a slight indentation; minor facial feature; the implant is expected to produce a slight improvement in appearance Grade 3: Moderately deep nasolabial folds; clear facial feature visible at normal appearance but not when stretched; excellent correction is expected with injectable implant Grade 4: Very long and deep nasolabial folds; prominent facial feature; 2mm visible fold when stretched; significant improvement is expected with injectable implant Grade 5: Extremely deep and long nasolabial folds, detrimental to facial appearance; 2-4mm visible V-shaped fold when stretched; unlikely to have satisfactory correction with injectable implant alone
Measured: 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®
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
Measured: 13th, 26th, 39th and 52nd week post-administration
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®
Grade 1: No visible nasolabial fold; continuous skin line Grade 2: Shallow but visible nasolabial fold with a slight indentation; minor facial feature; the implant is expected to produce a slight improvement in appearance Grade 3: Moderately deep nasolabial folds; clear facial feature visible at normal appearance but not when stretched; excellent correction is expected with injectable implant Grade 4: Very long and deep nasolabial folds; prominent facial feature; 2mm visible fold when stretched; significant improvement is expected with injectable implant Grade 5: Extremely deep and long nasolabial folds, detrimental to facial appearance; 2-4mm visible V-shaped fold when stretched; unlikely to have satisfactory correction with injectable implant alone
Measured: 13th, 26th, 39th and 52nd week post-administration
Number of subjects scored either 'Much Improved' or 'Improved' on GAIS evaluated by the Investigator for PLLA(PBF) versus Sculptra®
Measured: 13th, 26th, 39th and 52nd week post-administration
Subject's satisfaction score (Subjective 5-point scale with 1 being 'very satisfied' and 5 being 'very dissatisfied') of PLLA(PBF) versus Sculptra®
Measured: 13th, 26th, 39th and 52nd week post-administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start15 Apr 2024
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasolabial Fold WrinklesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Medical University, Panion & BF Biotech Inc.
- Responsible party
- Principal investigator, Hsiou-Hsin Tsai, Taipei Medical University Hospital
- Investigators
- Hsiou-Hsin Tsai, M.D. PhD., Principal investigator, Taipei Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06013332
- Sponsor's protocol ID
- PBF-PLLA-001
- Status last verified
- Jul 2024
- First submitted
- 13 Aug 2023
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06013332
- Acronym / sponsor ID
- PBF-PLLA-001
- Conditions
- Nasolabial Fold Wrinkles
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Taipei Medical University HospitalUniversity, hospital or other
- Collaborators
- Taipei Medical University, Panion & BF Biotech Inc.
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 28 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Group 1: right face will be injected with PBF PLLA microsphere, and left face with Sculptra®
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: PBF PLLA microsphere (injectable poly-L-lactic acid), Device: Sculptra®right face will be injected with PBF PLLA microsphere, and left face with Sculptra® |
| Group 2 | Experimental | Device: PBF PLLA microsphere (injectable poly-L-lactic acid), Device: Sculptra®right face will be injected with Sculptra® and left face with PBF PLLA microsphere |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- -
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Group 1, Group 2 |
| Sculptra®Sculptra® | Device | Group 1, Group 2 |
Primary outcome
Delta of the WAS score between the Baseline and 26 weeks after treatment assessed by the Independent Evaluators of PLLA(PBF) versus Sculptra®
Time frame: 26 weeks
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
8 secondary outcomes
Overall operation time during subcutaneous injection of PLLA(PBF) versus Sculptra®
Time frame: 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®
Time frame: 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®
Time frame: 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®
Time frame: 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®
Time frame: 13th, 26th, 39th and 52nd week post-administration
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®
Time frame: 13th, 26th, 39th and 52nd week post-administration
Number of subjects scored either 'Much Improved' or 'Improved' on GAIS evaluated by the Investigator for PLLA(PBF) versus Sculptra®
Time frame: 13th, 26th, 39th and 52nd week post-administration
Subject's satisfaction score (Subjective 5-point scale with 1 being 'very satisfied' and 5 being 'very dissatisfied') of PLLA(PBF) versus Sculptra®
Time frame: 13th, 26th, 39th and 52nd week post-administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsiou-Hsin Tsai, M.D. PhD. principal investigator
Taipei Medical University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PBF PLLA microsphere (injectable poly-L-lactic acid) and Sculptra® in people with Nasolabial Fold Wrinkles, run by Taipei Medical University Hospital at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delta of the WAS score between the Baseline and 26 weeks after treatment assessed by the Independent Evaluators of PLLA(PBF) versus Sculptra® (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.