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

Glabellar Frown Lines Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05481931
• Other study ID #: EV-010
• Status: Recruiting
• Start date: March 15, 2023
• Est. completion date: May 2026

Study information

• Verified date: March 2023
• Source: Evolus, Inc.
• Contact: Rose Monroe
• Phone: 8059794126
• Email: rose.monroe[@]evolus.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: May 2026
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glabellar Frown Lines

Intervention

Drug:
• prabotulinumtoxinA
Botulinum toxin Type A powder for solution for injection

Locations

Country	Name	City	State
Germany	Cologne Dermatology	Cologne

Sponsors (2)

Lead Sponsor	Collaborator
Evolus, Inc.	Avania

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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