Non Interventional Safety Study of NUCEIVA for the Treatment of Moderate-to-Severe Glabellar Lines (NCT05481931) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Non Interventional Safety Study of NUCEIVA for the Treatment of Moderate-to-Severe Glabellar Lines
Germany756 participantsStarted 2023-03-15
Plain-language summary
Non-interventional PASS of NUCEIVA for the treatment of moderate-to-severe glabellar lines to provide additional characterisation of the long-term safety of NUCEIVA in the real-world clinical practice setting.
Who can participate
Age range18 Years – 64 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Treatment Emergent Adverse Events
Timeframe: From the time of first dose until participant exits the study at 18 months post initial treatment