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botulinum toxin, Type A

Phase 2

Lateral Canthal Lines | Monoclonal antibody | Dermatology |cbdMD, Inc.|Last Updated: Apr 21, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

botulinum toxin, Type A · 1 trial · 2 indications

Phase 2 1
NCT03326856ET-01 in Subjects With Lateral Canthal LinesLateral Canthal Lines
COMPLETED48 Analytics
PHASE2COMPLETED
ET-01 in Subjects With Lateral Canthal Lines
Lateral Canthal Lines
NCT0332685648
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Study Endpoints

Primary Endpoints

Number of Participants With a Response Defined as IGA-C (Investigators Global Assessment) Score ≤ 2 and a SSA-C (Subject Self-Assessment) Score ≤ 2
Week 4

Composite of Investigators Global Assessment \& Subject Self-Assessment on contraction. Crow's Feet Wrinkle Scale where severity is scored between 0-4 (0=absent; 4=severe). The same scale is used for the Investigator's Assessment as well as the Subject's Self Assessment. To count, both assessments (on contraction) have to be "responders" defined as Score ≤ 2.

Secondary Endpoints

Total Number of Observations With a Response Defined as IGA-C Score ≤ 2
Week 2, 4, 8,12,18
Total Number of Observations With a Response Defined as SSA-C Score ≤ 2
Week 2, 4, 8,12,18
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
VehiclePLACEBO_COMPARATORVehicle
Dose 1EXPERIMENTALbotulinum toxin, Type A, Dose 1
Dose 2EXPERIMENTALbotulinum toxin, Type A, Dose 2
Dose 3EXPERIMENTALbotulinum toxin, Type A, Dose 3
Dose 4EXPERIMENTALbotulinum toxin, Type A, Dose 4

Interventions

NameTypeDescription
botulinum toxin, Type ABIOLOGICALtopical liniment
VehicleBIOLOGICALVehicle Formulation
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Eligibility Criteria

Age Range25 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * 25 - 65 years of age * minimal to moderate Crow's Feet wrinkles at rest * moderate to severe Crow's Feet wrinkles on contraction * willingness to refrain from any product affecting skin remodeling * female subjects must be not pregnant and non-lactating- Exclusion Criteria: ...

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 being studied for the treatment of lateral canthal lines, commonly known as crow's feet, which are wrinkles that appear at the outer corners of the eyes. It is currently in Phase 2 clinical development for this dermatological indication.

Who makes botulinum toxin, Type A?

Botulinum toxin, Type A is being developed by cbdMD, Inc., a company traded on the stock exchange under the ticker symbol YCBD. The company is conducting clinical research to evaluate the safety and efficacy of this product for lateral canthal lines.

What phase is botulinum toxin, Type A in?

Botulinum toxin, Type A is currently in Phase 2 clinical development. It is an investigational product and has not been approved by regulatory authorities. The Phase 2 trial for lateral canthal lines has been completed, and the product remains under investigation.

What clinical trials is botulinum toxin, Type A in?

Botulinum toxin, Type A has one completed Phase 2 clinical trial identified as NCT03326856, titled 'ET-01 in Subjects With Lateral Canthal Lines.' This randomized, double-blind, placebo-controlled study enrolled 48 participants in the United States to evaluate the treatment for crow's feet.

Is botulinum toxin, Type A the same as ET-01?

Yes, botulinum toxin, Type A is also known as ET-01. The clinical trial NCT03326856, which evaluated this product for lateral canthal lines, refers to it as ET-01 in its title, confirming that these names refer to the same investigational treatment.