An interventional study of PBF PLLA microsphere (injectable poly-L-lactic acid) and Sculptra® in Nasolabial Fold Wrinkles, sponsored by Taipei Medical University Hospital. Active, not recruiting at 2 sites in Taiwan. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by Taipei Medical University Hospital · Not applicable, Interventional, and Treatment
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:
Taipei Medical University Hospital is the lead sponsor of 62 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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right face will be injected with PBF PLLA microsphere, and left face with Sculptra®
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
Device: PBF PLLA microsphere (injectable poly-L-lactic acid) · Device: Sculptra®
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®
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
Time frame: 26 weeks
Overall operation time during subcutaneous injection of PLLA(PBF) versus Sculptra®
To compare the operational smoothness for physicians between the two medical devices
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®
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
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®
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
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®
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
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®
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
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®
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
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
Post injection treatment responses (From common treatment responses diary card) for safety evaluation of PBF PLLA microsphere versus Sculptra®
Time frame: During 2 weeks post-administration
Assessment of injection site pain of PBF PLLA microsphere versus Sculptra® by using Visual Analogue Scale (VAS) score
Time frame: immediately after injection and at 5-, 15- and 30- minute post-administration
Compare the treatment related adverse event
Time frame: During 52 weeks post-administration
This study is active, not recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Taipei Medical University Hospital