Phase III study of BTX-A-HAC NG in treatment of Glabellar Lines
Research type
Research Study
Full title
A Phase III, Randomised, Double Blind, Placebo Controlled and Open Label Phase, Multicentre Study to Investigate the Efficacy and Safety of BTX-A-HAC NG in the Treatment of Moderate to Severe Glabellar Lines, and Assess the Long Term Efficacy and Safety of BTX-A-HAC NG following Repeated Treatments in this Indication
IRAS ID
168002
Contact name
Christopher INGLEFIELD
Contact email
Sponsor organisation
Ipsen Innovation
Eudract number
2014-003841-86
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
This is phase 3 clinical study to assess the short term efficacy and safety of a single injection of a new formulation of a drug called Dysport® (approved as Azzalure® in Europe) which is used for the improvement in the appearance of glabellar lines (the vertical lines that appear on the forehead between the eyebrows) and to demonstrate the long term efficacy and safety of this study drug after repeated injections.
Dysport® is a natural toxin that has been shown to reduce the appearance of lines and folds of the face (wrinkles) by temporarily suppressing the contraction of the muscle groups responsible for the formation of those lines or folds. The muscles relaxation can last for up to 12 or 16 weeks, and in some cases, even longer. At low doses, Dysport® has been shown to suppress the muscular activity which allows the wrinkles to become less pronounced and the forehead region to appear smoother.
The study is composed of a double-blind period (neither subject nor the study doctor will know what treatment they receive ) followed by an open-label period (Participants will be treated with one to four injections of Dysport®.
Depending on response and on the study treatment frequency (every 12 weeks or less frequently), participants will be asked to attend a variable number of visits ranging from 15 to 26 visits over a period of 12 months (plus an additional 3 months follow up period after the last injection).This includes 1 screening visit, 1 baseline visit (this can be performed the same day as the screening visit), 12 up to 23 follow-up visits and 1 study completion or withdrawal visit.
A total of 580 participants (180 participants randomised in the double-blind period and an additional 400 new participants in the open label period) are planned to complete the study.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
15/EM/0096
Date of REC Opinion
9 Apr 2015
REC opinion
Further Information Favourable Opinion