191622-098 - Crow's Feet Lines
Research type
Research Study
Full title
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Single Treatment Cycle Study of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex in Subjects with Lateral Canthal Rhytides
IRAS ID
63462
Contact name
Simon Connolly
Sponsor organisation
Allergan Limited
Eudract number
2010-020827-28
Clinicaltrials.gov Identifier
Research summary
This study will evaluate the safety and efficacy of botulinum toxin type A (BOTOX) compared to placebo for the treatment of Crow's Feet Lines. Eligible subjects are 18 or over, male or female with moderate to severe crow's feet lines when smiling and should not have had treatment with botulinum toxin previously. Subjects will receive 1 treatment of either BOTOX or Placebo injected into their crow's feet line areas - 3 injections per side. Subjects will be followed up for approximately 5 months. Subjects will complete questionnaires about their experiences and feelings about their crow's feet lines, assess the seventy of their crow's feet lines, have photos taken, an examination of their muscle strength and blood taken for antibody testing.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
10/H1208/74
Date of REC Opinion
27 Oct 2010
REC opinion
Favourable Opinion