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
Results First Posted : February 5, 2019
Last Update Posted : April 24, 2019
|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
- The Safety of Repeat DWP-450 Treatments - Proportion of Subjects With at Least One Adverse Event Over 1 Year [ Time Frame: 365 days ]The primary safety analysis was the calculation of the proportion of subjects with at least one adverse event that occurred from Day 0 through Day 365.
- Change From Baseline Glabellar Line Scale (GLS) Score at Rest and at Maximum Frown [ Time Frame: 365 days ]Proportion of subjects with an improvement of 1 point or more (i.e., ≥1 point responders) on the GLS at rest at end of study/early termination: by Investigator assessment
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.|