Head-to-Head Comparison of All Botulinum Neurotoxin Type A Products for Glabellar Rhytides
- Registration Number
- NCT06448676
- Brief Summary
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 five 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.
- Detailed Description
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, triple-blind, randomized controlled trial will involve a structured intervention where participants receive one of five 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 240
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OnabotulinumtoxinA: 20 units Botulinum toxin type A 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) IncobotulinumtoxinA: 20 units Botulinum toxin type A 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) AbobotulinumtoxinA: 50 (Speywood) units Botulinum toxin type A 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) AbobotulinumtoxinA: 60 (Speywood) units Botulinum toxin type A 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) PrabotulinumtoxinA 20 units Botulinum toxin type A 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) Excluded: LetibotulinumtoxinA-wlbg: 20 units (reason for exclusion: not available in the EU). Botulinum toxin type A Arm Description: 20 units (4-4-4-4-4) Commercial Name: Letybo® Producing Company: Hugel Inc. Location: Chuncheon-si, South Korea Excluded: DaxibotulinumtoxinA 20 units (reason for exclusion: not available in the EU) Botulinum toxin type A 20 units (4-4-4-4-4) Commercial Name: Daxxify® Producing Company: Revance Therapeutics, Inc. Location: Nashville, Tennessee, USA
- Primary Outcome Measures
Name Time Method Duration of Clinical Efficacy 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.
- Secondary Outcome Measures
Name Time Method Social Functioning (FACE-Q) From baseline to week 16 FACE-Q Social Scores, (values 8-32), higher score means a better outcome
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) Median time to loss of effect
Incidence of Adverse Events (AEs) From baseline to week 16 Occurrences of adverse events such as ptosis, strabismus, and eyelid sensory disorders throughout the study period
Quality of Life (FACE-Q) From baseline to week 16 FACE-Q Psychological Wellbeing Scores, (values 10-40), higher score means a better outcome
Migraine Symptoms Baseline to week 4 Migraine Disability Assessment (MIDAS) Scores, (values 0-21+), higher score means a worse outcome
Satisfaction with the Result (FACE-Q) From baseline to week 16 FACE-Q Outcome Scores, (values 6-24), higher score means a better outcome
Side Effects (FACE-Q) First 2 weeks after treatment FACE-Q Early Life Impact Scores, (values 17-68), higher score means a worse outcome
Depressive Symptoms Baseline to week 4 Hospital Anxiety and Depression Scale (HADS) Depression Scores, (values 0-21), higher score means a worse outcome
Anxiety Symptoms Baseline to week 4 Hospital Anxiety and Depression Scale (HADS) Anxiety Scores, (values 0-21), higher score means a worse outcome
Headache Symptoms Baseline to week 4 Headache Impact Test (HIT-6) Scores, (values 36-78), higher score means a worse outcome