OBSERVATIONAL STUDY OF VISTABEL FOR THE TREATMENT OF CROW’S FEET

• Research type

  Research Study

• Full title

  OBSERVATIONAL POST-AUTHORISATION SAFETY STUDY OF VISTABEL® FOR THE TREATMENT OF CROW’S FEET LINES (CFL)

• IRAS ID

  217060

• Contact name

  John Quinn

• Contact email

  quinnmedicineman@gmail.com

• Sponsor organisation

  Allergan Pharmaceuticals Ireland

• Duration of Study in the UK

  3 years, 6 months, 1 days

• Research summary

  This study is a Post-authorisation Safety Study where participants will receive treatment for Crow’s Feet Lines (CFL) under standard care using Vistabel, and the study will collect data only (safety, demographic, medical history). There will be no study specific visits to sites and no procedures conducted as a part of this study.

  A minimum of 580 participants aged 18 and over will be recruited into this study across multiple countries, with the purpose of assessing the long-term safety profile of Vistabel for the treatment of CFL.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  16/LO/2266

• Date of REC Opinion

  22 Dec 2016

• REC opinion

  Favourable Opinion