Clinical trial NCT06448676: Head-to-Head Comparison of All Botulinum Neurotoxin Type A Products for Glabellar Rhytides
Official title: 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, Triple-Blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Wrinkle
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Universitair Medical Centrum Groningen
First posted: 2024-06-07
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a triple-blind, multi-center, parallel-group randomized controlled trial designed to compare the efficacy and safety of onabotulinumtoxinA, abobotulinumtoxinA, incobotulinumtoxinA, prabotulinumtoxinA, and daxibotulinumtoxinA, for the treatment of glabellar rhytides.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Duration of Clinical Efficacy
timeFrame: From baseline to week 16
Secondary outcomes:
measure: Duration of Clinical Efficacy
timeFrame: 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)
measure: Incidence of Adverse Events (AEs)
timeFrame: From baseline to week 16
measure: Quality of Life (FACE-Q)
timeFrame: From baseline to week 16
measure: Social Functioning (FACE-Q)
timeFrame: From baseline to week 16
measure: Satisfaction with the Result (FACE-Q)
timeFrame: From baseline to week 16
measure: Depressive Symptoms
timeFrame: Baseline to week 4
measure: Anxiety Symptoms
timeFrame: Baseline to week 4
measure: Migraine Symptoms
timeFrame: Baseline to week 4
measure: Headache Symptoms
timeFrame: Baseline to week 4
measure: Side Effects (FACE-Q)
timeFrame: First 2 weeks after treatment
Other outcomes:
Locations:
Study officials:
affiliation: Amsterdam University Medical Centers
name: Jan de Lange, MD DMD PhD
role: PRINCIPAL_INVESTIGATOR
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