Safety Study of DWP-450 (Botulinum Purified Neurotoxin, Type A) Injection to Treat Glabellar Lines

Phase 2 Completed 352 enrolled Evolus, Inc.

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to demonstrate the safety of multiple doses of DWP-450 (Botulinum purified neurotoxin, Type A) Injection in treatment of moderate to severe glabellar lines in adult subjects.

Timeline

Start: 2014-08
Primary completion: 2015-12
Completion: 2015-12

Outcome

Met primary endpoint

paper The difference of change between both groups was 0.0129 (95% confidence interval -0.2062-0.2319), within the non-inferiority margin of 0.45. PMID 26233808 ↗

Publications

Nam HS, Park YG, Paik NJ, Oh BM, Chun MH, Yang HE, Kim DH, Yi Y, Seo HG, Kim KD, Chang MC, Ryu JH, Lee SU. Efficacy and safety of NABOTA in post-stroke upper limb spasticity: a phase 3 multicenter, double-blinded, randomized controlled trial. J Neurol Sci. 2015 Oct 15;357(1-2):192-7. doi: 10.1016/j.jns.2015.07.028. Epub 2015 Jul 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Botulinum Toxins, Type A	Unknown	20 iu	Intramuscular

Indications

No indication recorded.