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

RecruitingPhase 4Ages 18 Years - anyFemaleAcademisch Medisch Centrum - Universiteit van Ams…
NCT06448676 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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 * Negative pregnancy test 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
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What it tests

  • Botulinum toxin type A
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Where

3 sites
Faceland
Amsterdam, Netherlands
Faceland
Eindhoven, Netherlands
Faceland
Utrecht, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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