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Botulinum toxin, Type A

Phase 3

Glabellar Frown Lines | Monoclonal antibody | Dermatology |Evolus, Inc. Common Stock|Last Updated: Mar 27, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials2
Total Enrollment654

FDA Designations

No designations recorded

Clinical trial landscape

Botulinum toxin, Type A · 2 trials · 1 indication

Phase 3 2
NCT02334423A Phase III Study to Demonstrate the Safety and Efficacy of DWP-450 to Treat Glabellar Lines - EV001Glabellar Frown Lines
COMPLETED330 Analytics
NCT02334436A Phase III Study to Demonstrate the Safety and Efficacy of DWP-450 to Treat Glabellar Lines - EV-002Glabellar Frown Lines
COMPLETED324 Analytics
PHASE3COMPLETED
A Phase III Study to Demonstrate the Safety and Efficacy of DWP-450 to Treat Glabellar Lines - EV001
Glabellar Frown Lines
NCT02334423330
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PHASE3COMPLETED
A Phase III Study to Demonstrate the Safety and Efficacy of DWP-450 to Treat Glabellar Lines - EV-002
Glabellar Frown Lines
NCT02334436324
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Study Endpoints

Primary Endpoints

Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject
Day 30

The primary efficacy end point assesses the effectiveness of DWP-450 against placebo on Day 30. The primary efficacy measure is a composite end point. Using the GLS scale, investigators and subjects will assess the glabellar lines at Day 0 and Day 30. A subject is a responder only if both the investigator and subject independently agree that a ≥2 improvement has occurred from Day 0 to Day 30. GLS is scored: 0=none, 1=mild, 2=moderate, 3=severe.

Secondary Endpoints

Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject
Day 120
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Botulinum toxin, Type AEXPERIMENTALBotulinum toxin, Type A
PlaceboPLACEBO_COMPARATOR0.9 % sterile, unpreserved saline

Interventions

NameTypeDescription
Botulinum toxin, Type ABIOLOGICALBotulinum toxin, Type A
0.9% sterile, unpreserved salineOTHERPlacebo
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Eligibility Criteria

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

Inclusion Criteria: * Subjects is an adult, of at least 18 years of age * Subject is able to provide informed consent and comply with study instructions * Subject has moderate to severe glabellar lines at maximum frown as assessed by the investigator using the GLS * Subject has moderate to severe g...

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

What is Botulinum toxin, Type A used for?

Botulinum toxin, Type A is used for the treatment of glabellar frown lines, the vertical wrinkles that appear between the eyebrows. It is being developed as an injectable treatment in the dermatology therapeutic area. The drug is currently in Phase 3 clinical development and is not yet approved by the FDA.

Who makes Botulinum toxin, Type A?

Botulinum toxin, Type A is being developed by Evolus, Inc., a company traded on the stock exchange under the ticker symbol EOLS. Evolus is conducting the clinical development program for this product, which is intended to treat glabellar frown lines.

What phase is Botulinum toxin, Type A in?

Botulinum toxin, Type A is in Phase 3 clinical development. Two Phase 3 trials have been completed, with a total of 654 participants enrolled. The drug is investigational and has not received FDA approval. It is being studied for the treatment of glabellar frown lines.

What clinical trials is Botulinum toxin, Type A in?

Botulinum toxin, Type A has completed two Phase 3 clinical trials: NCT02334423, known as EV001, with 330 participants, and NCT02334436, known as EV-002, with 324 participants. Both trials were randomized, double-blind, placebo-controlled studies conducted in the United States with healthy volunteers aged 18 years and older.

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

Yes, Botulinum toxin, Type A is the same as DWP-450. The Phase 3 clinical trials for this product were conducted under the name DWP-450, as indicated in the trial titles. This alternative name may be used in clinical research and regulatory contexts.