DWP-450 for treatment of moderate to-severe glabellar lines
Research type
Research Study
Full title
A phase III, multi-center, randomized, double blind, active and placebo control, single dose trial to demonstrate the safety and efficacy of DWP-450 in adult subjects for treatment of moderate-to-severe glabellar lines
IRAS ID
167392
Contact name
Christopher Inglefield
Contact email
Sponsor organisation
Evolus Inc.
Eudract number
2014-001063-12
Duration of Study in the UK
0 years, 8 months, 31 days
Research summary
This is a phase 3 randomised, double blind study to assess the efficacy & safety of DWP-450 as compared with BOTOX® and placebo in treatment of moderate to severe glabellar (frown) lines associated with activity of forehead muscles and muscles between the eyebrows in adult participants.
The study is funded by Evolus Inc.
Both study drug and active control are a Clostridium botulinum toxin type A. Study drug vials contain 100 units of lyophilized DWP-450, active control vial contains 100 units of lyophilized BOTOX® and placebo vial will be empty. Using a needle and syringe, the participant will be injected into 5 areas around the glabellar region of the forehead.
497 subjects will be randomly assigned to either DWP-450, BOTOX®, or placebo from 20 sites world-wide (2 sites in the UK). Approximately 50 patients will be recruited in the UK with participation expected to be 150 days.
The study will involve screening, treatment & follow up visits at days 14, 30, 90, 120 and final visit on day 150.
Study assessments will involve medical history, demographics, physical examinations, Investigator assessments and photography of the brow area.
REC name
London - Central Research Ethics Committee
REC reference
15/LO/0437
Date of REC Opinion
19 May 2015
REC opinion
Further Information Favourable Opinion