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Botulinum purified neurotoxin, Type A

Phase 2

Glabellar Frown Lines | Monoclonal antibody | Dermatology |Evolus, Inc. Common Stock|Last Updated: Apr 24, 2019

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment352

FDA Designations

No designations recorded

Clinical trial landscape

Botulinum purified neurotoxin, Type A · 1 trial · 1 indication

Phase 2 1
NCT02184988Safety Study of DWP-450 (Botulinum Purified Neurotoxin, Type A) Injection to Treat Glabellar LinesGlabellar Frown Lines
COMPLETED352 Analytics
PHASE2COMPLETED
Safety Study of DWP-450 (Botulinum Purified Neurotoxin, Type A) Injection to Treat Glabellar Lines
Glabellar Frown LinesUnlock trial analytics

Study Endpoints

Primary Endpoints

The Safety of Repeat DWP-450 Treatments - Proportion of Subjects With at Least One Adverse Event Over 1 Year
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.

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Botulinum neurotoxin, Type AEXPERIMENTALDWP-450 (Botulinum purified neurotoxin, Type A) Injection

Interventions

NameTypeDescription
Botulinum purified neurotoxin, Type ABIOLOGICALThe 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.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria (A subject must meet all of the following inclusion criteria in order to be eligible for enrollment in the study): * Subjects must be an adult 18 years of age or over * Subject is able to provide informed consent and comply with study instructions * Subject has moderate to severe...

Countries:United States
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Frequently asked questions about Botulinum purified neurotoxin, Type A

What is Botulinum purified neurotoxin, Type A used for?

Botulinum purified neurotoxin, Type A is an investigational drug being studied for the treatment of glabellar frown lines, the vertical wrinkles between the eyebrows. It is in Phase 2 clinical development and has not been approved by the FDA. A completed clinical trial evaluated its safety in 352 participants with this condition.

Who makes Botulinum purified neurotoxin, Type A?

Botulinum purified neurotoxin, Type A is being developed by Evolus, Inc., a company traded on the stock market under the ticker symbol EOLS. The company is conducting clinical research on this product for the treatment of glabellar frown lines.

What phase is Botulinum purified neurotoxin, Type A in?

Botulinum purified neurotoxin, Type A is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received FDA approval. One Phase 2 trial has been completed, and the drug is not currently in any active clinical trials.

What clinical trials is Botulinum purified neurotoxin, Type A in?

Botulinum purified neurotoxin, Type A was studied in clinical trial NCT02184988, titled 'Safety Study of DWP-450 (Botulinum Purified Neurotoxin, Type A) Injection to Treat Glabellar Lines.' This Phase 2 trial was completed in the United States and enrolled 352 participants aged 18 years and older.

Is Botulinum purified neurotoxin, Type A the same as DWP-450?

Yes, Botulinum purified neurotoxin, Type A is also known as DWP-450. The clinical trial NCT02184988 used the name DWP-450 in its title, referring to the same drug being developed by Evolus, Inc. for the treatment of glabellar frown lines.