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.
This is a prospective, multicentre, non-interventional observational Post Authorisation Safety Study; Safety data will be collected from approximately 750 patients at 20 sites throughout the United Kingdom and the European Union over an 18 month evaluation period. Eligible patients will receive an initial treatment of 20 Units of NUCEIVA. Further treatment will not be specified, recommended or required by the protocol. Patients may receive up to 6 treatments of 20 Units of NUCEIVA over the course of the 18-month study.
Study Type
OBSERVATIONAL
Enrollment
756
Botulinum toxin Type A powder for solution for injection
Cologne Dermatology
Cologne, Germany
Treatment Emergent Adverse Events
Number and percentage of patients with an event that started or worsened in severity at or after the first dose of NUCEIVA
Time frame: From the time of first dose until participant exits the study at 18 months post initial treatment
Adverse Events of Particular Interest
Number and percentage of patients that experience an adverse event related to eye disorders and adverse events potentially suggestive of the distant spread of toxin.
Time frame: From the time of first dose until participant exits the study at 18 months post initial treatment
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