Non Interventional Safety Study of NUCEIVA for the Treatment of Moderate-to-Severe Glabellar Lines

Evolus

Status

Enrolling

Conditions

Glabellar Frown Lines

Treatments

Drug: prabotulinumtoxinA

Study type

Observational

Funder types

Industry

Identifiers

NCT05481931

EV-010

Details and patient eligibility

About

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.

Full 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.

Enrollment

750 estimated patients

Sex

All

Ages

18 to 64 years old

Volunteers

Accepts Healthy Volunteers

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.