ET-01 in Subjects With Lateral Canthal Lines

Study Overview
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Brief Summary
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This study tests an investigational drug formulation called ET-01, botulinum toxin, Type A, topical, in lateral canthal lines (LCL).

Detailed Description
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This product is being tested for its ability to reduce lateral canthal lines, also known as Crow's Feet.

Official Title
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Clinical Trial to Evaluate ET-01 in Subjects With Lateral Canthal Lines

Conditions
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Lateral Canthal Lines, Crow's Feet

Intervention / Treatment
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* Biological: botulinum toxin, Type A
* Biological: Vehicle


Participation Criteria
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Eligibility Criteria
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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: history of adverse reactions to any prior botulinum toxin treatments history of vaccination or non-response to any prior botulinum toxin treatments botulinum toxin treatment in the prior 6 months present or history of neuromuscular disease, eyelid ptosis, muscle weakness, paralysis, or dry eye history of peri-ocular surgery, brow lift or related procedures procedures affecting the lateral canthal region in the prior 12 months application of topical prescription medication to the treatment area female subjects who are pregnant or are nursing a child

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: sequential, dose escalating study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Vehicle<br>Vehicle | Biological: Vehicle<br>* Vehicle Formulation<br>|
| Experimental: Dose 1<br>botulinum toxin, Type A, Dose 1 | Biological: botulinum toxin, Type A<br>* topical liniment<br>* Other names: ET-01;|
| Experimental: Dose 2<br>botulinum toxin, Type A, Dose 2 | Biological: botulinum toxin, Type A<br>* topical liniment<br>* Other names: ET-01;|
| Experimental: Dose 3<br>botulinum toxin, Type A, Dose 3 | Biological: botulinum toxin, Type A<br>* topical liniment<br>* Other names: ET-01;|
| Experimental: Dose 4<br>botulinum toxin, Type A, Dose 4 | Biological: botulinum toxin, Type A<br>* topical liniment<br>* Other names: ET-01;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With a Response Defined as IGA-C (Investigators Global Assessment) Score ≤ 2 and a SSA-C (Subject Self-Assessment) Score ≤ 2 | 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. | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Number of Observations With a Response Defined as IGA-C Score ≤ 2 | Total number of observations with a Score of ≤ 2 on the Investigators Global Assessment on Contraction, IGA-C, using the Crow's Feet Wrinkle Scale, where severity is scored between 0-4 (0=absent; 4=severe). To count, a responder is defined as Score ≤ 2. The observation period ranges from the earliest expected onset of action at Week 2 to the likely offset of action by Week 18. | Week 2, 4, 8,12,18 | 
| Total Number of Observations With a Response Defined as SSA-C Score ≤ 2 | Total number of observations with a Score of ≤ 2 on the Subject Self-Assessment on Contraction, SSA-C, using the Crow's Feet Wrinkle Scale, where severity is scored between 0-4 (0=absent; 4=severe). To count, a responder is defined as Score ≤ 2. The observation period ranges from the earliest expected onset of action at Week 2 to the likely offset of action by Week 18. | Week 2, 4, 8,12,18 |