NCT06013332进行中（未招募）不适用
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
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Delta of the WAS score between the Baseline and 26 weeks after treatment assessed by the Independent Evaluators of PLLA(PBF) versus Sculptra®
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 ≥
- •WAS Score is determined by investigator.
- •Participant whose difference in WAS score of nasolabial folds on two sides of face ≤
- •WAS Score is determined by investigator.
- •Participant's skin condition is considered by Investigator suitable for the treatment of Poly-L-lactic Acid (PLLA).
排除标准
- •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).
- •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.
- •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.
- •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.
研究组 & 干预措施
Group 1
Experimental
right face will be injected with PBF PLLA microsphere, and left face with Sculptra®
干预措施: PBF PLLA microsphere (injectable poly-L-lactic acid) (Device)
Group 1
Experimental
right face will be injected with PBF PLLA microsphere, and left face with Sculptra®
干预措施: Sculptra® (Device)
Group 2
Experimental
right face will be injected with Sculptra® and left face with PBF PLLA microsphere
干预措施: PBF PLLA microsphere (injectable poly-L-lactic acid) (Device)
Group 2
Experimental
right face will be injected with Sculptra® and left face with PBF PLLA microsphere
干预措施: Sculptra® (Device)
结局指标
主要结局
Delta of the WAS score between the Baseline and 26 weeks after treatment assessed by the Independent Evaluators of PLLA(PBF) versus Sculptra®
时间窗: 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
次要结局
- Overall operation time during subcutaneous injection of PLLA(PBF) versus Sculptra®(First week from the Start of administration to the end of 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)
- 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®(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)
- Delta of the WSRS score between the Baseline and 26 weeks after treatment assessed by the Independent Evaluators of PLLA(PBF) versus Sculptra®(26 weeks)
- 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®(13th, 26th, 39th and 52nd week post-administration)
- 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®(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®(13th, 26th, 39th and 52nd week post-administration)
研究者
Hsiou-Hsin Tsai
Visiting Staff
Taipei Medical University Hospital
研究点 (2)
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