Glabellar Frown Lines Clinical Trial
Official title:
A Multi-center, Open Label, Multiple Dose, Phase II Trial to Demonstrate the Safety of DWP-450 in Adult Subjects for Treatment of Moderate-to-severe Glabellar Lines.
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.
Three hundred and fifty subjects will be enrolled and injected with the study drug DWP-450
over the course of the 365 day study.
Subjects with moderate or severe glabellar lines at maximum frown on the 4 point Glabellar
Line Scale (GLS, 0=none, 1= mild, 2=moderate, 3=severe), as judged by the investigator, will
be eligible for injection with DWP-450. After each injection, subjects will be followed and
are eligible for a repeat injection if their GLS is ≥2 at maximum frown, as judged by the
Investigator. If a subject does not have a GLS≥2 they will be followed monthly until eligible
for repeat treatment.
Subjects may receive up to a maximum of 4 treatments and will be followed for 365 days from
initial treatment.
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