Observational study on the safety of NUCEIVA for treating frown lines
Non-Interventional Post-Authorisation Safety Study of NUCEIVA for the Treatment of Moderate-to-Severe Glabellar Lines
This study is testing the long-term safety of NUCEIVA, a treatment for frown lines, in about 750 patients across the UK and EU.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 750 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Evolus, Inc. Industry-sponsored |
| Locations | 1 site (Cologne) |
| Trial ID | NCT05481931 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the long-term safety of NUCEIVA, a treatment for moderate-to-severe glabellar lines, in a real-world clinical setting. Approximately 750 patients will be enrolled across 20 sites in the UK and EU, receiving an initial treatment of 20 Units of NUCEIVA. Patients may receive up to 6 treatments over an 18-month period, although further treatments are not mandated by the study protocol. The study will collect safety data to better understand the effects of NUCEIVA in everyday practice.
Who should consider this trial
Good fit: Ideal candidates are adults under 65 with moderate to severe glabellar lines who experience significant psychological impact from their appearance.
Not a fit: Patients with certain medical conditions, such as myasthenia gravis or those currently participating in other interventional studies, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term safety profile of NUCEIVA, enhancing patient confidence in its use.
How similar studies have performed: Previous studies on similar botulinum toxin treatments have shown positive safety profiles, suggesting that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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: * 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.
Where this trial is running
Cologne
- Cologne Dermatology — Cologne, Germany (Recruiting)
Study contacts
- Study coordinator: Rose Monroe
- Email: rose.monroe@evolus.com
- Phone: 8059794126
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.