Safety Study of DWP-450 (Botulinum Purified Neurotoxin, Type A) Injection to Treat Glabellar Lines (EV-004)
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|ClinicalTrials.gov Identifier: NCT02184988|
Recruitment Status : Completed
First Posted : July 9, 2014
Results First Posted : February 5, 2019
Last Update Posted : April 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Glabellar Frown Lines||Biological: Botulinum purified neurotoxin, Type A||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||352 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Open Label|
|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.|
|Study Start Date :||August 2014|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Experimental: Botulinum neurotoxin, Type A
DWP-450 (Botulinum purified neurotoxin, Type A) Injection
Biological: Botulinum purified neurotoxin, Type A
The subject is to be injected intra-muscularly into a total of five sites: the mid-line of the procures muscle, the inferomedial aspect of each corrugator muscle and the superior middle aspect of each corrugator, at least 1 cm above the bony orbital rim. Each site is injected with 0.1 ml (4U), for a total of 20 U and 0.5 ml.
Other Name: DWP-450 (Botulinum purified neurotoxin, Type A) Injection
- 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.
- Percentage of Subjects With an Improvement of 1 Point or More (i.e., ≥1 Point Responders) at Rest on Day 365, by Investigator Assessment on the Glabellar Line Scale (GLS) [ Time Frame: 365 Days ]GLS is scored: 0=none, 1=mild, 2=moderate, 3=severe. A 1-point decrease in GLS score is equivalent to a 1-point improvement on the GLS; as such, both meet the definition of a 1-point responder on the GLS
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): NCT02184988
|United States, California|
|ATS Clinical Research|
|Santa Monica, California, United States, 90404|
|Study Director:||Rui Avelar, MD||Evolus, Inc.|