Aesthetics of the Periorbital Area after Treatment with JUVÉDERM® Fillers and BOTOX®/VISTABEL®

• Research type

  Research Study

• Full title

  A Prospective, Open-Label Study to Evaluate Subject's Satisfaction with the Aesthetics of the Periorbital Area After Treatment of the Upper and/or Mid Face with JUVÉDERM® Fillers and BOTOX®/VISTABEL®

• IRAS ID

  1005685

• Contact name

  Aleksandra Jankielewicz

• Contact email

  uk.reg.csm.cta@abbvie.com

• Sponsor organisation

  AbbVie Deutschland GmbH & Co. KG

• Eudract number

  2022-000417-13

• Research summary

  Different studies have shown the negative effects of aging around the area of the eyes. Signs of aging may contribute to erroneously projected emotions (e.g., anger, tiredness, or sadness) that do not reflect the individual's true feelings affecting interpersonal relationships. Minimally invasive aesthetic treatments with botulinum toxin and hyaluronic acid (HA) fillers are used to treat wrinkles and volume deficiencies associated with the appearance of most of the signs of aging. The purpose of this study is to evaluate the subject’s satisfaction after the treatment of JUVÉDERM® fillers and BOTOX®/VISTABEL® on the upper and/or mid face, which includes areas around the eyes, under the eyes, eyebrows, the temple, and the cheek. This Phase 4 post-marketing study is an open-label study in which all subjects will receive active study treatment. This study will enroll approximately 80 healthy male and female subjects ages 40 to 65 from different racial/ethnic backgrounds (for example, Asian, Indian, Caucasian, Black) across 10 sites in Australia, Belgium, and United Kingdom. Each subject will attend seven (7) in-clinic study visits and will be in the study for approximately 90 days.
  The initial treatment of the JUVÉDERM fillers (Juvéderm VOLBELLA with lidocaine, Juvéderm VOLIFT with lidocaine, and/or Juvéderm VOLUMA with lidocaine) will be given on Day 1, and if needed, a touch-up treatment will be given on Day 14. On Day 30, the Juvéderm VOLBELLA with lidocaine filler, may be given in the under the eyes area only, followed by a touch-up treatment, if needed on Day 44. On Day 60, subjects will receive study drug BOTOX/VISTABEL for Glabellar Lines, and Crow’s Feet Lines. All subjects will return for the study exit visit on Day 90.

• REC name

  Wales REC 1

• REC reference

  22/WA/0273

• Date of REC Opinion

  5 Dec 2022

• REC opinion

  Further Information Unfavourable Opinion