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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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05481931). StuddyBuddy aggregates publicly available trial information.