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

NCT05481931 | Active Not Recruiting

• 1 other identifier: EV-010
• Study Type: observational
• Target: 756
• Locations: 1 country
• Sites: 1

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.

Conditions

Glabellar Frown Lines

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adverse Events of Particular Interest

  From the time of first dose until participant exits the study at 18 months post initial treatment

Study Arms (3)

Safety Population

The safety population will consist of all patients who receive at least one treatment of NUCEIVA.

Drug: prabotulinumtoxinA

Botulinum Toxin Naïve

Sub-population of patients that have never been treated with botulinum toxin

Drug: prabotulinumtoxinA

Botulinum Toxin Exposed

Sub-population of patients that have previously been treated with botulinum toxin

Drug: prabotulinumtoxinA

Interventions

prabotulinumtoxinA DRUG

Botulinum toxin Type A powder for solution for injection

Also known as: Jeuveau, Nuceiva

Botulinum Toxin Exposed; Botulinum Toxin Naïve; Safety Population

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Evolus, Inc.: lead
• Avania: collaborator

Study Sites (1)

Cologne Dermatology

Cologne, Germany

Location

MeSH Terms

Interventions

prabotulinumtoxin A

Study Officials

• Rui Avelar

  Evolus, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 1, 2022
• Study Start: March 15, 2023
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: August 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)