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.
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
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)
Parallel
Botulinum toxin type A
DrugHead-to-head comparison of all commercially available botulinum neurotoxin type A products
Duration of Clinical Efficacy
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.
Duration of Clinical Efficacy
Median time to loss of effect
Incidence of Adverse Events (AEs)
Occurrences of adverse events such as ptosis, strabismus, and eyelid sensory disorders throughout the study period
Quality of Life (FACE-Q)
FACE-Q Psychological Wellbeing Scores, (values 10-40), higher score means a better outcome
Social Functioning (FACE-Q)
FACE-Q Social Scores, (values 8-32), higher score means a better outcome
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead sponsor
Universitair Medical Centrum Groningen
Collaborator
