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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Glabellar Frown Lines
• Intervention / Treatment: Drug: prabotulinumtoxinA

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.

• Study Type: Observational
• Enrollment (Anticipated): 750

Contacts and Locations

Study Locations

• Germany
  • Cologne, Germany
    • Recruiting
    • Cologne Dermatology
    • Contact: Wolfgang Philipp-Dormston, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Approximately 750 patients will be recruited at 20 sites from the United Kingdom, Germany, France, Sweden and Spain.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Safety Population; The safety population will consist of all patients who receive at least one treatment of NUCEIVA.	Drug: prabotulinumtoxinA; Botulinum toxin Type A powder for solution for injection; Other Names: Jeuveau; Nuceiva
Botulinum Toxin Naïve; Sub-population of patients that have never been treated with botulinum toxin	Drug: prabotulinumtoxinA; Botulinum toxin Type A powder for solution for injection; Other Names: Jeuveau; Nuceiva
Botulinum Toxin Exposed; Sub-population of patients that have previously been treated with botulinum toxin	Drug: prabotulinumtoxinA; Botulinum toxin Type A powder for solution for injection; Other Names: Jeuveau; Nuceiva

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From the time of first dose until participant exits the study at 18 months post initial treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From the time of first dose until participant exits the study at 18 months post initial treatment

Collaborators and Investigators

• Sponsor: Evolus, Inc.
• Collaborators: Avania

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2023
• Primary Completion (Anticipated): May 1, 2025
• Study Completion (Anticipated): May 1, 2026

Study Registration Dates

• First Submitted: July 28, 2022
• First Submitted That Met QC Criteria: July 28, 2022
• First Posted (Actual): August 1, 2022

Study Record Updates

• Last Update Posted (Actual): March 17, 2023
• Last Update Submitted That Met QC Criteria: March 15, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: EV-010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No