Safety Study of DWP-450 (Botulinum Toxin, Type a) to Treat Glabellar Lines - EV-006 (EV-006)
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|ClinicalTrials.gov Identifier: NCT02428608|
Recruitment Status : Completed
First Posted : April 29, 2015
Last Update Posted : March 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Glabellar Frown Lines||Biological: DWP-450 (Botulinum purified neurotoxin, Type A)||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||570 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||This is an open label safety study|
|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|
|Study Start Date :||May 2015|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||November 2016|
Experimental: Botulinum toxin, Tyoe A
DWP-450 (Botulinum toxin, Type A)
Biological: DWP-450 (Botulinum purified neurotoxin, Type A)
Botulinum toxin, Type A
Other Name: DWP-450
- Safety (adverse reactions) [ Time Frame: 365 days ]Safety will be evaluated by incidence, severity and duration of any adverse reactions during the study period.
- Exploratory Efficacy (Global Aesthetic Improvement Score) [ Time Frame: 365 days ]The by subject and investigator assessment will be measured at defined time points over the course of the study and summarized.
- Exploratory Efficacy (Subject Satisfaction will be measured using the Subject Satisfaction Scale) [ Time Frame: 365 days ]At defined time points, Subject Satisfaction will be measured using the Subject Satisfaction Scale and summarized.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02428608
|United States, Nebraska|
|The Advanced Skin Research Center at Skin Specialists, PC|
|Omaha, Nebraska, United States, 68144|
|Study Director:||Rui Avelar, MD||Evolus, Inc.|