Glabellar Frown Lines Clinical Trial
Official title:
A Multi-center, Open Label, Single Dose, Phase II Trial to Demonstrate the Safety of DWP-450 in Adult Subjects for Treatment of Moderate-to-severe Glabellar Lines
The primary objective is to demonstrate the safety of multiple doses of DWP-450 purified Botulinum neurotoxin, Type A, in treatment of moderate to severe glabellar lines associated with corrugator and procerus muscle activity in adult subjects.
Up to five hundred and thirty (530) subjects will be enrolled and injected with the study
drug DWP-450 over the course of the 365 day study.
Subjects with moderate-to-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.
Subjects may receive up to a maximum of 4 treatments and will be followed for 365 days from
initial treatment.
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