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

Recruiting

• Conditions: Glabellar Frown Lines
• Interventions: Drug: prabotulinumtoxinA

• Registration Number: NCT05481931
• Lead Sponsor: Evolus, Inc.

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.

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 Timeline

• Study First Submitted: 2022-07-28
• Study First Submitted QC: 2022-07-28
• Study First Posted: 2022-08-01
• Study Start: 2023-03-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-23
• Last Update Posted: 2024-05-24
• Primary Completion: 2025-12
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 750

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Safety Population	prabotulinumtoxinA	The safety population will consist of all patients who receive at least one treatment of NUCEIVA.
Botulinum Toxin Naïve	prabotulinumtoxinA	Sub-population of patients that have never been treated with botulinum toxin
Botulinum Toxin Exposed	prabotulinumtoxinA	Sub-population of patients that have previously been treated with botulinum toxin

Primary Outcome Measures

Name	Time	Method
Treatment Emergent Adverse Events	From the time of first dose until participant exits the study at 18 months post initial treatment	Number and percentage of patients with an event that started or worsened in severity at or after the first dose of NUCEIVA

Secondary Outcome Measures

Name	Time	Method
Adverse Events of Particular Interest	From the time of first dose until participant exits the study at 18 months post initial treatment	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.

Trial Locations

Locations (1)

Cologne Dermatology; 🇩🇪 Cologne, Germany