Nuceiva safety checked in 756 patients for frown lines
NCT ID NCT05481931
First seen Jun 24, 2026 · Last updated Jul 01, 2026 · Updated 4 times
Summary
This completed study looked at the long-term safety of Nuceiva (a botulinum toxin injection) for treating moderate-to-severe frown lines between the eyebrows. It involved 756 adults under 65 who received the treatment in real-world clinics. The main goal was to track any side effects, especially eye problems or signs of the toxin spreading. The study did not test how well the treatment works, only its safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- prabotulinumtoxinA (a type of botulinum toxin, also known as Jeuveau or Nuceiva)
- What this could lead to
- If successful, this study could confirm that Nuceiva is safe for long-term use in treating frown lines.
- What could go wrong
- This is an observational safety study, not a test of effectiveness. It cannot prove the treatment works better than others, and rare side effects may still emerge.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
756 people
The number who actually took part.
- Started
-
Mar 2023
- Finished
-
Apr 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Approximately 750 patients will be recruited at 20 sites from the United Kingdom, Germany, France, Sweden and Spain.
- Ages
-
18 to 64 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patient is an adult less than 65 years of age * Patient presenting to a participating physician has moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar lines) * Patient finds their glabellar lines have an important psychological impact * Written informed consent is obtained from the patient. Exclusion Criteria: * Patient has a legal incapacity or limited legal capacity without legal guardian representation * Patient is currently participating in an interventional study of any investigational product, device or procedure * Patient has a hypersensitivity to the active substance or to any of the excipients listed in Section 6.1 of the Summary of Product Characteristics * Patient has a generalised disorder of muscle activity (e.g. myasthenia gravis or Eaton Lambert Syndrome) * Patient has an infection or inflammation at any of the proposed injection sites * Patient has a history of dysphagia and/or aspiration * Female patient is pregnant, is of childbearing potential and not using contraception, is breast feeding, or is planning to become pregnant during the next 18 months * Patient has received prior botulinum toxin for any indication within 3 months of study enrolment.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Cologne Dermatology
Cologne, Germany
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