CompletedNCT05481931Updated Jun 30, 2026

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

An observational study in Glabellar Frown Lines, sponsored by Evolus, Inc.. Completed at 1 site in Germany. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-30.

Sponsored by Evolus, Inc. · Observational

Study type: Observational
Model: Other
Time perspective: Prospective
Enrollment: 756
Ages: 18 Years to 64 Years
Sex: All

Study 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.

Read the 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 studied

Glabellar Frown Lines

In context

Lead sponsor

Evolus, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 64 Years
Sexes eligible: All
Accepts healthy volunteers: Yes
Sampling method: Probability sample

Study population

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

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

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 design

Observational model: Other
Time perspective: Prospective
Enrollment: 756 participants (actual)
Patient registry: No

Groups and cohorts

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

DrugprabotulinumtoxinA
Botulinum toxin Type A powder for solution for injection
Also known as: Jeuveau, Nuceiva

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

1 site

Cologne Dermatology
Cologne, Germany

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05481931
Lead sponsor: Evolus, Inc.
Collaborators: Avania
Responsible party: Sponsor
First posted: Aug 1, 2022
Start date: Mar 15, 2023
Primary completion: Apr 13, 2026
Completion: Apr 13, 2026
Last update: Jun 30, 2026

Study contacts

Rui Avelar

study director · Evolus, Inc.

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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