ET-01 in Subjects With Lateral Canthal Lines, LCL-208

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: females 25 - 65 years of age minimal to moderate Crow's Feet wrinkles at rest moderate to severe Crow's Feet on contraction adequate vision to assess facial wrinkles in a mirror willingness to refrain from products affecting skin remodeling female subjects must be not pregnant and non-lactating subjects should be in good general health 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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Female

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 cohort, 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: ET-01 345U<br>botulinum toxin, Type A, Dose 1, 345 U | Biological: botulinum toxin, Type A<br>* topical liniment<br>* Other names: ET-01;|
| Experimental: ET-01 1100U<br>botulinum toxin, Type A, Dose 2, 1100 U | 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 Change in IGA-C (Investigators Global Assessment) Score by at Least 2 Ordinals From Baseline to Week 4 | Investigators Global Assessment of the Crow's Feet Wrinkle Scale where severity is scored between 0-4 (0=absent; 4=severe). Response is defined as change by at least two ordinals from Baseline to Week 4. | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Number of Observations With a Response Defined as Change ≥2 in IGA-C and SSA-C Score at Any Post Baseline Visit | Total number of observations with a change in the Investigators Global Assessment on Contraction, IGA-C, and 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 a change by at least two ordinals in both assessments. The observation period includes all post-baseline visits from Week 1 to Week 26. | Week 1, 2, 4, 8,12,18, and 26 | 
| Total Number of Observations With a Response Defined as Change in SSA-C Score ≥ 2 at Any Time Between Week 4 and Week 12 | Total number of observations with a change by at least two ordinals in the Subjects 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 an improvement ≥ 2 score points. The observation period covers the time time of expected peak efficacy from Week 4 to Week 12. | Week 4, 8,and 12 |