M21-310: BOTOX® for the Treatment of Platysma Prominence

• Research type

  Research Study

• Full title

  A Phase 3 Multicenter, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for the Treatment of Platysma Prominence

• IRAS ID

  301273

• Contact name

  Aleksandra Jankielewicz

• Contact email

  global-clinical-trials@abbvie.com

• Sponsor organisation

  Abbvie

• Eudract number

  2021-000240-22

• Clinicaltrials.gov Identifier

  NCT04949399

• Duration of Study in the UK

  1 years, 10 months, 10 days

• Research summary

  Research Summary
  The purpose of the study is to evaluate the safety and effects of onabotulinumtoxinA (BOTOX) for the temporary improvement in the appearance of platysma prominence.

  Study doctors will randomise participants into 1 of the 2 groups, called treatment arms. There is a 1 in 2 chance that a participant will be assigned to placebo. Around 400 participants will be enrolled in the study across approximately 35 sites in USA, Belgium, Canada, Germany, Russia, and the UK.

  Participants will receive a single treatment of intramuscular injection of onabotulinumtoxinA (BOTOX) or placebo on Day 1 during this 4 month long study.

  Summary of Results
  https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fwww.abbvieclinicaltrials.com%252Fstudy%252F%253Fid%253DM21-310%2523additional-resources-section%2FNBTI%2FJzO5AQ%2FAQ%2F059f1356-e575-4778-9905-c7fe39e9ae05%2F2%2Fqo3_Jm5eBw%23additional-resources-section&data=05%7C02%7Cleicestersouth.rec%40hra.nhs.uk%7Cd6b328db608b4be6de7408dcff22640d%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638665770373087435%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=a%2BP84OuVMC73EDBe%2F6DJQqSehycF0gLua3uH7WaE5n4%3D&reserved=0

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  21/EM/0213

• Date of REC Opinion

  15 Dec 2021

• REC opinion

  Further Information Favourable Opinion