Head-to-Head Comparison of BoNT-A Treatments for Glabellar Lines
Official title: 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
Run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · NCT06448676 · Data updated 2026-11-12
A multicenter, triple-blind study will test all FDA-approved Botulinum Neurotoxin Type A products to see which best reduces glabellar frown lines and lasts the longest.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 325 (estimated) |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 3 sites (Amsterdam and 2 other locations) |
| Status | Recruiting |
| Started | February 2, 2026 |
| Main results expected | January 15, 2027 |
| Study ends | February 1, 2027 |
| Registry record updated | August 14, 2026 |
| Trial ID | NCT06448676 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18 and older with moderate to severe glabellar lines who consent and meet ASA 1 or 2.
✕Probably not a fit
Individuals with ASA 3 or higher, neuromuscular disorders, pregnancy or breastfeeding, or prior lifetime Botulinum toxin treatment may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, multicenter trial compares all five FDA-approved BoNT-A products for treating moderate to severe glabellar lines in adult women. Participants will receive one BoNT-A formulation, with follow-up through 16 weeks and weekly selfie photos to document changes. Blinding is maintained to avoid bias, and safety is monitored throughout. Data will be analyzed for duration of effect and adverse events, using standard clinical scales and Kaplan-Meier methods.
Why it matters
Potential benefit: If successful, the study could identify the BoNT-A product that provides the longest-lasting wrinkle reduction.
How similar studies have gone: Previous research has explored individual BoNT-A products, but comprehensive head-to-head comparisons across all approved products are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Faceland
Amsterdam, Netherlands Recruiting -
Faceland
Eindhoven, Netherlands Recruiting -
Faceland
Utrecht, Netherlands Recruiting
Study contacts
- Principal investigator: Jan de Lange, MD DMD PhD — Amsterdam UMC, location VUmc
- Study coordinator: Serge A. Steenen, MD DMD
- Email: s.a.steenen@amsterdamumc.nl
- Phone: +316 26 457 415
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.