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Completed
NCT05481931
Non Interventional Safety Study of NUCEIVA for the Treatment of Moderate-to-Severe Glabellar Lines
Conditions: Glabellar Frown Lines
Sex: All
Ages: 18 Years – 64 Years
Healthy volunteers: Yes
Enrollment: 756
Sponsor: Evolus, Inc.
Location: Cologne Dermatology Cologne
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT05481931). StuddyBuddy aggregates publicly available trial information.