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

Launched by EVOLUS, INC. · Jul 28, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the long-term safety of a treatment called NUCEIVA for moderate-to-severe glabellar lines, which are the frown lines that appear between your eyebrows when you frown. The goal is to understand how this treatment works in real-world settings, outside of a controlled clinical environment. The trial is currently recruiting participants who are adults younger than 65 years old and have noticeable frown lines that affect their emotional well-being.

To be eligible, participants should find that their frown lines have a significant psychological impact on them and must provide written consent to join the study. However, there are some people who cannot participate, including those with certain medical conditions or who are pregnant. If you join the trial, you can expect regular check-ins with healthcare professionals to monitor your safety and the effects of the treatment. This study aims to gather more information to help ensure that NUCEIVA is safe and effective for people dealing with these types of lines.

Gender

ALL

Eligibility 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.