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

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Primary completion date: Jan 1, 2027 to Jan 15, 2027v6
  2. Notable Trial status: Not Yet Recruiting to Recruiting Enrollment target: 200 to 325 · Primary completion date: Oct 1, 2025 to Jan 1, 2027 · Start date changed from estimate of Jan 1, 2025 to Feb 2, 2026 · 5 morev5 Show 8 more changesShow less
    • Enrollment target: 200 to 325
    • Primary completion date: Oct 1, 2025 to Jan 1, 2027
    • Start date changed from estimate of Jan 1, 2025 to Feb 2, 2026
    • Study sites: 0 to 3
    • Completion date: Nov 1, 2025 to Feb 1, 2027
    • Study description revised
    • Study arms: 7 to 5
    • Eligibility criteria expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  3. Minor Enrollment target: 240 to 200 Study arms: 6 to 7v4 Show 1 more changeShow less
    • Study arms: 6 to 7
  4. Minor Re-verified, no change to tracked fieldsv3
  5. Minor Secondary endpoints revised (10)v2 See this version in full on ClinicalTrials.gov ↗
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06448676
Lead Sponsor Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators: Universitair Medical Centrum Groningen
Conditions Wrinkle, Glabellar Frown Lines, Glabellar Furrowing
Enrollment 325 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov