Head-to-Head Comparison of All Botulinum Neurotoxin Type A Products for Glabellar Rhytides

July 29, 2024 updated by: Prof. dr. J. de Lange, MD DMD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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)
Drug: Botulinum toxin type A
Head-to-head comparison of all commercially available botulinum neurotoxin type A products
Active Comparator: 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)
Drug: Botulinum toxin type A
Head-to-head comparison of all commercially available botulinum neurotoxin type A products
Active Comparator: 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)
Drug: Botulinum toxin type A
Head-to-head comparison of all commercially available botulinum neurotoxin type A products
Active Comparator: 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)
Drug: Botulinum toxin type A
Head-to-head comparison of all commercially available botulinum neurotoxin type A products
Active Comparator: PrabotulinumtoxinA 20 units
20 units (4-4-4-4-4) Commercial Name: Jeuveau® Producing Company: Evolus, Inc. Location: Newport Beach, California, USA
Drug: Botulinum toxin type A
Head-to-head comparison of all commercially available botulinum neurotoxin type A products
Active Comparator: DaxibotulinumtoxinA 20 units
20 units (4-4-4-4-4) Commercial Name: Daxxify® Producing Company: Revance Therapeutics, Inc. Location: Nashville, Tennessee, USA
Drug: Botulinum toxin type A
Head-to-head comparison of all commercially available botulinum neurotoxin type A products

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Clinical Efficacy
Time Frame: 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.
From baseline to week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Clinical Efficacy
Time Frame: 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
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)
Time Frame: From baseline to week 16
Occurrences of adverse events such as ptosis, strabismus, and eyelid sensory disorders throughout the study period
From baseline to week 16
Quality of Life (FACE-Q)
Time Frame: From baseline to week 16
FACE-Q Psychological Wellbeing Scores, (values 10-40), higher score means a better outcome
From baseline to week 16
Social Functioning (FACE-Q)
Time Frame: From baseline to week 16
FACE-Q Social Scores, (values 8-32), higher score means a better outcome
From baseline to week 16
Satisfaction with the Result (FACE-Q)
Time Frame: From baseline to week 16
FACE-Q Outcome Scores, (values 6-24), higher score means a better outcome
From baseline to week 16
Depressive Symptoms
Time Frame: Baseline to week 4
Hospital Anxiety and Depression Scale (HADS) Depression Scores, (values 0-21), higher score means a worse outcome
Baseline to week 4
Anxiety Symptoms
Time Frame: Baseline to week 4
Hospital Anxiety and Depression Scale (HADS) Anxiety Scores, (values 0-21), higher score means a worse outcome
Baseline to week 4
Migraine Symptoms
Time Frame: Baseline to week 4
Migraine Disability Assessment (MIDAS) Scores, (values 0-21+), higher score means a worse outcome
Baseline to week 4
Headache Symptoms
Time Frame: Baseline to week 4
Headache Impact Test (HIT-6) Scores, (values 36-78), higher score means a worse outcome
Baseline to week 4
Side Effects (FACE-Q)
Time Frame: First 2 weeks after treatment
FACE-Q Early Life Impact Scores, (values 17-68), higher score means a worse outcome
First 2 weeks after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Collaborators

Universitair Medical Centrum Groningen

Investigators

  • Principal Investigator: Jan de Lange, MD DMD PhD, Amsterdam University Medical Centers

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

June 3, 2024

First Submitted That Met QC Criteria

June 3, 2024

First Posted (Actual)

June 7, 2024

Study Record Updates

Last Update Posted (Actual)

July 30, 2024

Last Update Submitted That Met QC Criteria

July 29, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-514936-26-00

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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