NCT06448676 Head-to-Head Comparison of All Botulinum Neurotoxin Type A Products for Glabellar Rhytides
| NCT ID | NCT06448676 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Condition | Wrinkle |
| Study Type | INTERVENTIONAL |
| Enrollment | 325 participants |
| Start Date | 2026-02-02 |
| Primary Completion | 2027-01-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 325 participants in total. It began in 2026-02-02 with a primary completion date of 2027-01-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Jan de Lange, MD DMD PhD
PRINCIPAL INVESTIGATOR
Amsterdam UMC, location VUmc
Frequently Asked Questions
Who can join the NCT06448676 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Wrinkle. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06448676 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06448676 currently recruiting?
Yes, NCT06448676 is actively recruiting participants. Contact the research team at s.a.steenen@amsterdamumc.nl for enrollment information.
Where is the NCT06448676 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands, Eindhoven, Netherlands, Utrecht, Netherlands.
Who is sponsoring the NCT06448676 clinical trial?
NCT06448676 is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The principal investigator is Jan de Lange, MD DMD PhD at Amsterdam UMC, location VUmc. The trial plans to enroll 325 participants.