NCT05481931

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 756 (actual)
• Sponsor: Evolus, Inc. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Glabellar Frown Lines

Interventions

Type	Name	Description
DRUG	prabotulinumtoxinA	Botulinum toxin Type A powder for solution for injection

Timeline

• Start date: 2023-03-15
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2022-08-01
• Last updated: 2025-08-05

Locations

1 site across 1 country: Germany