Actively Recruiting
Comparing All FDA-Approved Botulinum Neurotoxin Type A Products for Treating Moderate to Severe Frown Lines in Women A Multicenter, Triple-Blind Randomized Controlled Trial
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2026-07-02
325
Participants Needed
3
Research Sites
4 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to compare the effectiveness and safety of all commercially available Botulinum Neurotoxin Type A BoNT-A products in treating glabellar rhytides, commonly known as frown lines. It is a multicenter, triple-blind, randomized controlled trial enrolling women aged 18 years or older with moderate to severe frown lines. The study addresses which BoNT-A product provides the longest lasting effect and compares safety profiles, filling gaps in current knowledge. Participants will receive injections of one of five different BoNT-A formulations, including Botox, Xeomin, Dysport at two dosing levels, and Jeuveau. Each treatment involves specific unit doses injected into targeted facial muscles. The study includes baseline and follow-up assessments over 16 weeks, with weekly smartphone photographs documenting changes. Questionnaires on satisfaction, quality of life, and symptoms will be completed at the start and end of the study. During the study, participants will be closely monitored through clinical assessments and secure digital submissions of weekly photos. Researchers will evaluate the duration of treatment efficacy using standardized scales and analyze safety by tracking side effects. Secondary outcomes include quality of life, social functioning, and symptom changes over several weeks. The total participation period extends up to 16 weeks with active follow-up to assess treatment effects and participant experiences.
CONDITIONS
Brief Title
Head-to-Head Comparison of All Botulinum Neurotoxin Type A Products for Glabellar Rhytides
Research Team
S
Serge A. Steenen, MD DMD
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