Glabellar Frown LinesNCT05481931
Non Interventional Safety Study of NUCEIVA for the Treatment of Moderate-to-Severe Glabellar Lines
An observational study of Glabellar Frown Lines, run by Evolus, Inc. at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Glabellar Frown Lines
- What is being tested?
- prabotulinumtoxinA
- Type of treatment
- Injection or infusion
- How many people
- 756 participants
- Where
- 1 siteGermany
- Study dates
- 15 Mar 2023to 13 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Approximately 750 patients will be recruited at 20 sites from the United Kingdom, Germany, France, Sweden and Spain.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-Interventional Post-Authorisation Safety Study of NUCEIVA for the Treatment of Moderate-to-Severe Glabellar Lines
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
- Glabellar Frown Lines
- Being tested
- prabotulinumtoxinA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prabotulinumtoxinADrug
Also called Jeuveau, Nuceiva
Botulinum toxin Type A powder for solution for injection
| Study group | Role | What they receive |
|---|---|---|
| Safety Population | The safety population will consist of all patients who receive at least one treatment of NUCEIVA. Receives: Drug: prabotulinumtoxinA | |
| Botulinum Toxin Naïve | Sub-population of patients that have never been treated with botulinum toxin Receives: Drug: prabotulinumtoxinA | |
| Botulinum Toxin Exposed | Sub-population of patients that have previously been treated with botulinum toxin Receives: Drug: prabotulinumtoxinA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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.
Measured: From the time of first dose until participant exits the study at 18 months post initial treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start15 Mar 2023
- Primary completion13 Apr 2026
- Study completion13 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glabellar Frown LinesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 756 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evolus, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avania
- Responsible party
- Sponsor
- Investigators
- Rui Avelar, Study director, Evolus, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05481931
- Sponsor's protocol ID
- EV-010
- Status last verified
- Jun 2026
- First submitted
- 28 Jul 2022
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Interventional Post-Authorisation Safety Study of NUCEIVA for the Treatment of Moderate-to-Severe Glabellar Lines
- ClinicalTrials.gov ID
- NCT05481931
- Acronym / sponsor ID
- EV-010
- Conditions
- Glabellar Frown Lines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 756 participants (actual)
- Lead sponsor
- Evolus, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Avania
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 13 Apr 2026 (actual)
- Study completion
- 13 Apr 2026 (actual)
- First posted
- 1 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Safety Population | – | Drug: prabotulinumtoxinAThe safety population will consist of all patients who receive at least one treatment of NUCEIVA. |
| Botulinum Toxin Naïve | – | Drug: prabotulinumtoxinASub-population of patients that have never been treated with botulinum toxin |
| Botulinum Toxin Exposed | – | Drug: prabotulinumtoxinASub-population of patients that have previously been treated with botulinum toxin |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Approximately 750 patients will be recruited at 20 sites from the United Kingdom, Germany, France, Sweden and Spain.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prabotulinumtoxinAAlso: Jeuveau, NuceivaBotulinum toxin Type A powder for solution for injection | Drug | Botulinum Toxin Exposed, Botulinum Toxin Naïve, Safety Population |
Primary outcome
Treatment Emergent Adverse Events
Time frame: 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
1 secondary outcome
Adverse Events of Particular Interest
Time frame: From the time of first dose until participant exits the study at 18 months post initial treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rui Avelar study director
Evolus, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glabellar Frown Lines, run by Evolus, Inc. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Emergent Adverse Events (time frame: From the time of first dose until participant exits the study at 18 months post initial treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.