Clinical trial NCT05481931: Non Interventional Safety Study of NUCEIVA for the Treatment of Moderate-to-Severe Glabellar Lines
Official title: Non-Interventional Post-Authorisation Safety Study of NUCEIVA for the Treatment of Moderate-to-Severe Glabellar Lines
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Glabellar Frown Lines
Lead sponsor: Evolus, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Avania
First posted: 2022-08-01
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Approximately 750 patients will be recruited at 20 sites from the United Kingdom, Germany, France, Sweden and Spain.

Brief 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.

Detailed description: 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.

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.

Primary outcomes:
measure: Treatment Emergent Adverse Events
timeFrame: From the time of first dose until participant exits the study at 18 months post initial treatment
Secondary outcomes:
measure: Adverse Events of Particular Interest
timeFrame: From the time of first dose until participant exits the study at 18 months post initial treatment
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Cologne Dermatology
Study officials:
affiliation: Evolus, Inc.
name: Rui Avelar
role: STUDY_DIRECTOR
References: