LIPS

• Research type

  Research Study

• Full title

  LIPS: A Prospective, Open-label Study to Evaluate the Effectiveness of Juvéderm® VOLIFT™ with Lidocaine for Lip Augmentation

• IRAS ID

  249698

• Contact name

  Graeme Kerson

• Contact email

  Kerson_Graeme@Allergan.com

• Sponsor organisation

  Allergan Pharmaceuticals International Limited

• Duration of Study in the UK

  0 years, 10 months, 29 days

• Research summary

  Lip augmentation is a type of cosmetic surgery or non-surgical procedure that aims to improve the appearance of the lips by using fillers.
  Hyaluronic Acid (HA) occurs naturally in skin but as part of the natural aging process our skin loses HA over time.
  HA fillers are fillers that are injected directly into the skin. Juvéderm® VOLIFT™ with Lidocaine is a type of non-animal HA filler with numbing agent (lidocaine) added.
  Juvéderm® VOLIFT™ with Lidocaine gained CE mark in October 2011. The CE mark means Juvéderm® VOLIFT™ with Lidocaine is already approved for use and meets the required health, safety, and environmental protection standards for products sold within the European Economic Area (EEA).
  In this study Juvéderm® VOLIFT™ with Lidocaine will be used in line with it’s CE mark.
  The research aspect of this study is data collection to better understand how well the filler treatment (Juvéderm® VOLIFT™ with Lidocaine) works by
  • monitoring and following up participants for 6 months after the treatment
  • taking standardised 2D and 3D photographs
  • asking for participant feedback in the form of a diary and the use of questionnaires.

  There will be approximately 30 patients in this study from clinics in the UK.

• REC name

  West Midlands - Black Country Research Ethics Committee

• REC reference

  18/WM/0296

• Date of REC Opinion

  21 Nov 2018

• REC opinion

  Further Information Favourable Opinion