Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06448676
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-03
Brief Title:
Head-to-Head Comparison of All Botulinum Neurotoxin Type A Products for Glabellar Rhytides
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None