Impression 3
Research type
Research Study
Full title
Evaluation of the Safety and Efficacy of Treatment With BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for Subjects With Forehead and Glabellar Facial Rhytides (Forehead Lines, Glabellar Lines, Lateral Canthal Lines)
IRAS ID
164680
Contact name
Sheetal Dyall
Contact email
Sponsor organisation
Allergan Limited
Eudract number
2014-001815-38
Duration of Study in the UK
1 years, 5 months, 0 days
Research summary
The purpose of this study is to investigate the safety and effectiveness of botulinum toxin (BOTOX®) in the treatment of moderate to severe forehead lines, glabellar lines (frown lines between the eyebrows) and crow’s feet lines (lines on the outer sides of the eyes).
BOTOX® has been approved for the treatment of crow’s feet (lateral canthal lines) and frown (glabellar) lines in a number of countries and has also been approved for the treatment of crossed eyes (strabismus), eyelid twitching (blepharospasm), movement disorder of the head and neck (cervical dystonia), excessive sweating (primary axillary hyperhidrosis), focal spasticity including the treatment of upper limb spasticity associated with stroke in adults, dynamic equinus foot deformity in paediatric cerebral palsy patients, chronic migraine headache in adults and overactive bladder.
BOTOX® is an investigational (experimental) drug in this study meaning that it has not been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of forehead, glabellar, and crow’s feet lines. That is why it is being investigated in this study.
There are two periods to this study; period 1 is randomised, double-blinded, placebo-controlled and will last approximately 6 months. Period 1 will assess the safety and efficacy of BOTOX ® treatment for forehead lines. Participants will be randomly assigned to one of 3 treatment groups; 80% of participants will receive BOTOX® and 20% of participants will receive placebo (a substance that is not designed to do anything). Neither the study doctor nor the participants will know which treatment the participants are receiving. Following Period 1, all participants will continue to open-label treatment in Period 2, meaning that they will all receive BOTOX ®. Period 2 will last 6 months and assess the safety of repeat administration of BOTOX®.
About 750 participants will be recruited at approximately 25 sites in North America, Europe and Russia.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
14/NW/1353
Date of REC Opinion
5 Nov 2014
REC opinion
Further Information Favourable Opinion