RecruitingPhase 4NCT06448676

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

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, Double-Blind, Randomized Controlled Trial


Sponsor

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

Enrollment

325 participants

Start Date

Feb 2, 2026

Study Type

INTERVENTIONAL

Conditions

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 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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria4

  • 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

Exclusion Criteria6

  • 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

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Interventions

DRUGBotulinum toxin type A

Head-to-head comparison of all commercially available botulinum neurotoxin type A products


Locations(3)

Faceland

Amsterdam, Netherlands

Faceland

Eindhoven, Netherlands

Faceland

Utrecht, Netherlands

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NCT06448676


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