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

Last updated: May 23, 2024
Sponsor: Evolus, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

prabotulinumtoxinA

Clinical Study ID

NCT05481931
EV-010
  • Ages 18-64
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion Criteria:

  • Patient is an adult less than 65 years of age

  • Patient presenting to a participating physician has moderate to severe verticallines 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

Exclusion Criteria:

  • Patient has a legal incapacity or limited legal capacity without legal guardianrepresentation

  • Patient is currently participating in an interventional study of any investigationalproduct, device or procedure

  • Patient has a hypersensitivity to the active substance or to any of the excipientslisted in Section 6.1 of the Summary of Product Characteristics

  • Patient has a generalised disorder of muscle activity (e.g. myasthenia gravis orEaton 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 usingcontraception, 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 ofstudy enrolment.

Study Design

Total Participants: 750
Treatment Group(s): 1
Primary Treatment: prabotulinumtoxinA
Phase:
Study Start date:
March 15, 2023
Estimated Completion Date:
January 31, 2026

Study 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.

Connect with a study center

  • Cologne Dermatology

    Cologne,
    Germany

    Active - Recruiting

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