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
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
- •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).
- •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.
- •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.
- •Participant who has serious systematic disease that judged by Investigator which is not suitable for the treatment.
- •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.
- •Participant who previously had or have risks factors for hypertrophic scarring or keloid formation near the treatment area.
- •Participant who has used immune system suppression drugs, steroids, anti-inflammatory drugs, anticoagulant drugs, or aspirin within 7 days before treatment.
- •Female participant who is pregnant or lactating.
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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