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| Name | Class |
|---|---|
| Taipei Medical University | OTHER |
| Panion & BF Biotech Inc. | INDUSTRY |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | right face will be injected with PBF PLLA microsphere, and left face with Sculptra® |
|
| Group 2 | Experimental | right face will be injected with Sculptra® and left face with PBF PLLA microsphere |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall operation time during subcutaneous injection of PLLA(PBF) versus Sculptra® | To compare the operational smoothness for physicians between the two medical devices | 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® |
| Measure | Description | Time Frame |
|---|---|---|
| Post injection treatment responses (From common treatment responses diary card) for safety evaluation of PBF PLLA microsphere versus Sculptra® | During 2 weeks post-administration | |
| Assessment of injection site pain of PBF PLLA microsphere versus Sculptra® by using Visual Analogue Scale (VAS) score |
Inclusion Criteria:
Exclusion Criteria:
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1. Participant who has previous tissue augmenting therapy, contouring or revitalization treatment in or near the treatment area prior to the Baseline visit.
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.
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| Name | Affiliation | Role |
|---|---|---|
| Hsiou-Hsin Tsai, M.D. PhD. | Taipei Medical University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Medical University Hospital | Taipei | Taiwan | ||||
| Taipei Municipal Wanfang Hospital |
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| Sculptra® | Device | 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 |
| 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 | 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 | 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 | 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 | 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® | 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® | 13th, 26th, 39th and 52nd week post-administration |
| immediately after injection and at 5-, 15- and 30- minute post-administration |
| Compare the treatment related adverse event | During 52 weeks post-administration |
| Taipei |
| Taiwan |