Head-to-Head Comparison of All Botulinum Neurotoxin Type A Products for Glabellar Rhytides
Status:
NOT_YET_RECRUITING
Trial end date:
2025-11-01
Target enrollment:
Participant gender:
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.
Phase:
PHASE4
Details
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)