Head-to-Head Comparison of the Efficacy and Safety of All Five Commercially Available Botulinum Neurotoxin Type A Products for the Treatment of Glabellar Rhytides: A Multicenter, Double-Blind, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 325
- 试验地点
- 3
- 主要终点
- Duration of Clinical Efficacy
研究概览
简要总结
Study Type: This is a multicenter, triple-blind, randomized controlled trial.
Purpose: The goal of this clinical trial is to compare the effectiveness and safety of all commercially available Botulinum Neurotoxin Type A (BoNT-A) products for treating glabellar rhytides, commonly known as frown lines. This study is designed to provide comprehensive data on how these treatments compare in terms of improving frown lines and the duration of their effects.
Main Questions the Study Aims to Answer:
Which BoNT-A product provides the longest lasting effect on reducing glabellar rhytides? How do these products compare in terms of safety and the occurrence of side effects?
Participant Tasks:
Women aged 18 years or older with moderate to severe glabellar lines will participate.
Participants will receive injections of a BoNT-A product into specific facial muscles.
They will need to take weekly photographs using their smartphones to document changes in their frown lines.
These photos will be securely sent to our research team for analysis. Participants will complete questionnaires at the start and end of the study to assess their satisfaction, quality of life, and any changes in their condition.
Comparison Group:
Researchers will compare participants receiving different types of BoNT-A products to see which one is more effective at reducing frown lines and maintaining these effects over time.
The safety profiles of these products will also be compared to determine which has the fewest and least severe side effects.
This study aims to fill important gaps in our understanding of Botulinum Neurotoxin Type A treatments, guiding more effective clinical decisions and improving patient outcomes.
详细描述
Background: Glabellar rhytides, commonly known as frown lines, are a significant aesthetic concern for many individuals, leading to increasing utilization of Botulinum Neurotoxin Type A (BoNT-A) treatments. Despite multiple products being available, comprehensive comparative data on their efficacy and safety are limited. This trial aims to fill this evidence gap by evaluating and comparing the effectiveness and safety profiles of all five FDA-approved BoNT-A products.
Methods: Conducted across several clinical sites, this multicenter, double-blind, randomized controlled trial will involve a structured intervention where participants receive one of the different BoNT-A formulations. The study employs a stringent blinding and randomization process to ensure the objectivity and reliability of the results. Data on treatment efficacy, safety, and participant-reported outcomes will be collected at baseline and follow-up through direct clinical assessments and secure digital communication methods.
Data Collection and Analysis: Data collection will include baseline and 16-week follow-up assessments using standardized clinical scales and self-reported question anaires. Participants will document 30 weekly progress through standardized 'selfie' photos using a secure, encrypted application to ensure data privacy. The primary outcome, the duration of treatment efficacy, will be analyzed using Kaplan-Meier survival analysis. Secondary outcomes, including the incidence of adverse events and participant satisfaction, will be analyzed using repeated measures ANOVA and logistic regression. Detailed duration of effect will be assessed using Kaplan-Meier curves and Cox proportional hazards models.
Statistical Analysis
The study is powered to detect meaningful clinical differences between the treatment groups with a high degree of statistical confidence. The analysis will explore treatment effects over time and assess factors influencing treatment efficacy and safety.
Conclusion: By rigorously comparing all available BoNT-A products, this study will provide critical insights into their relative effectiveness and safety, significantly informing clinical decision-making and optimizing patient care strategies for treating glabellar lines. The findings are expected to enhance the understanding of treatment dynamics and guide future therapeutic approaches in aesthetic medicine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Trial participants, data collectors, the statistician, and outcome assessors were blinded to the study-group assignments. Blinded syringes are labeled a sticker containing no information other than the allocated study number. After reconstitution, syringes were stored under hygienic non-sterile conditions between 39-46F in medical refrigerators. The safety related to this sterile transfer is substantiated by several studies.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 18 years or over, with moderate to severe glabellar lines
- •Willing to provide written informed consent
- •American Society of Anesthesiologists (ASA) Physical Status Classification 1 or 2
- •Negative pregnancy test
排除标准
- •ASA Classification 3 or over
- •History of hypersensitivity or adverse reactions to botulinum toxin or any of its components
- •Infection at the injection site
- •Previous treatment with botulinum toxin (lifetime)
- •Pregnant or breastfeeding women
- •Neuromuscular disorders or conditions that could interfere with the study assessments
研究组 & 干预措施
PrabotulinumtoxinA 20 units
20 units (4-4-4-4-4) Commercial Name: Jeuveau® Producing Company: Evolus, Inc. Location: Newport Beach, California, USA Additional Commercial Names: Nuceiva® (for aesthetic use in some regions)
干预措施: Botulinum toxin type A (Drug)
AbobotulinumtoxinA: 60 (Speywood) units
60 units (12-12-12-12-12) Commercial Name: Dysport® Producing Company: Ipsen Biopharmaceuticals, Inc. Location: Paris, France Additional Commercial Names: Azzalure® (for aesthetic use in some regions)
干预措施: Botulinum toxin type A (Drug)
AbobotulinumtoxinA: 50 (Speywood) units
50 units (10-10-10-10-10) Commercial Name: Dysport® Producing Company: Ipsen Biopharmaceuticals, Inc. Location: Paris, France Additional Commercial Names: Azzalure® (for aesthetic use in some regions)
干预措施: Botulinum toxin type A (Drug)
OnabotulinumtoxinA: 20 units
20 units (4-4-4-4-4) Commercial Name: Botox® Producing Company: Allergan, an AbbVie company Location: Dublin, Ireland Additional Commercial Names: Vistabel® (in some regions, especially Europe)
干预措施: Botulinum toxin type A (Drug)
IncobotulinumtoxinA: 20 units
20 units (4-4-4-4-4) Commercial Name: Xeomin® Producing Company: Merz Pharmaceuticals Location: Frankfurt, Germany Additional Commercial Names: Bocouture® (for aesthetic use in some regions)
干预措施: Botulinum toxin type A (Drug)
结局指标
主要结局
Duration of Clinical Efficacy
时间窗: From baseline to week 16
Period until loss of treatment effect, measured as the percentage of participants who maintain at least a 1-point improvement in glabellar line severity at maximum frown from baseline to week 16, assessed using the "four-point clinical severity score for glabellar frown lines" developed by Honeck.
次要结局
- Social Functioning (FACE-Q)(From baseline to week 16)
- Duration of Clinical Efficacy(Kaplan-Meier survival curves and Cox proportional hazards models to analyze the time to complete loss of effect across the entire study duration (From baseline to week 30))
- Incidence of Adverse Events (AEs)(From baseline to week 16)
- Quality of Life (FACE-Q)(From baseline to week 16)
- Migraine Symptoms(Baseline to week 4)
- Satisfaction with the Result (FACE-Q)(From baseline to week 16)
- Side Effects (FACE-Q)(First 2 weeks after treatment)
- Depressive Symptoms(Baseline to week 4)
- Anxiety Symptoms(Baseline to week 4)
- Headache Symptoms(Baseline to week 4)
研究者
Prof. dr. J. de Lange, MD DMD
Prof. dr. Jan de Lange, MD DMD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)