NUCEIVA

• Research type

  Research Study

• Full title

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

• IRAS ID

  311427

• Contact name

  David B Eccleston

• Sponsor organisation

  Evolus Inc.,

• Duration of Study in the UK

  3 years, 2 months, 30 days

• Research summary

  The Evolus study is a prospective, multi-centre, non-interventional post-authorisation safety study, designed to assess the long-term safety of NUCEIVA (prabotulinumtoxin type A) as observed in the real-world clinical practice setting when administered as indicated in the EU/UK. NUCEIVA is authorised for the treatment of moderate to severe glabellar lines when the severity of the above facial lines has an important psychological impact in adults below 65 years of age. NUCEIVA contains the active substance botulinum toxin type A, which when injected directly into the muscles above and between the eyebrows, causes muscle relaxation, aiding to make the glabellar lines less noticeable.

  Safety data will be collected from approximately 750 patients at 20 sites throughout the UK and EU over an 18-month evaluation period, which will include adult male and female patients below the age of 65 years who qualify and independently elect to receive treatment with NUCEIVA for their moderate to severe glabellar lines. Collection of this safety data is a condition of NUCEIVA holding market authorisation, and will support the life-cycle management of this medicinal product. The physician and patient will have agreed on the initial treatment of 20U NUCIEVA prior to deciding to participate in the study. Following enrolment in the study and administration of the initial treatment, further treatment will not be specified, recommended, or required by the MAH, however, patients may receive up to 6 additional treatments of 20U of NUICEVA over the 18-month study. Subjects will record any changes to any aspect of their health in an observational diary during the 18-month study, and these will form the research results.

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  22/LO/0597

• Date of REC Opinion

  14 Oct 2022

• REC opinion

  Further Information Favourable Opinion