ET-01 in Subjects With Lateral Canthal Lines, LCL-210

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 (LCL), 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, LCL, Crow's Feet

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: able to understand and give written informed consent 25 - 65 years of age willing to have facial pictures/videos taken per protocol mild or less Crow's Feet wrinkles (IGA 0-2) at rest moderate to severe Crow's Feet (IGA 3-4) on contraction ability to correctly grade a series of Crow's Feet pictures moderate to severe Crow's Feet (SSA 3-4) on contraction have adequate vision without the use of eyeglasses to assess facial wrinkles in a mirror (contact lenses are OK) willingness to refrain from the use of facial fillers, retinoids, botulinum toxins, laser treatments, or any product affecting skin remodeling or that might cause an active dermal response during the course of the study female subjects of childbearing potential must have a negative urine pregnancy test and be non-lactating at the Baseline visit female subjects of childbearing potential must utilize one of the following methods of birth control throughout the study: intra-uterine device (IUD), diaphragm, a condom, a spermicidal gel or foam, oral contraceptives (provided subject has been utilizing this method for at least 3 months prior to Baseline and has not changed the brand within this period), or patch, injectable, implantable, or vaginal ring contraceptives. Subjects may also participate if they are surgically sterilized (tubal sterilization or hysterectomy) or are in menopause. subjects should be in good general health as determined by the Investigator and free of any disease that may interfere with study evaluations or the Investigational Product. Exclusion Criteria: history of adverse reactions to any prior botulinum toxin treatments history of vaccination with botulinum toxin history of non-response to any prior botulinum toxin treatments any botulinum toxin treatment anywhere in the prior 6 months history of participation in ET-01-LCL-210 in previous Cohorts 1 or 2 at any time in the past history of periocular surgery, brow lift or related procedures soft tissue augmentation or any procedures affecting the lateral canthal region in the prior 12 months dermabrasion or laser treatment in the periocular region in the last 6 months topical prescription-strength retinoids in the prior 3 months to the treatment area application of any topical prescription medication to the treatment area within 14 days prior to treatment subjects on clinically significant, concomitant drug therapy (See Section 5.3 below).). present or history of neuromuscular disease, eyelid ptosis, muscle weakness or paralysis present or history of dry eye hemophilia, hemorrhagic disorder, hemostatic dysfunction or other blood clotting disorders use of systemic aminoglycosides in the week prior to treatment application participation in another investigational drug trial or receiving any investigational treatment(s) within 30 days of Baseline alcohol or drug abuse within the past 3 years psychiatric disease interfering with the subject's ability to give informed consent refusal or inability to comply with the requirements of the protocol for any reason

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: Parallel Assignment
Interventional Model Description: vehicle controlled, parallel group
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Vehicle<br>Vehicle, topical liniment, administered once at baseline | Biological: Vehicle<br>* topical liniment without investigational product<br>* Other names: ET-01 Vehicle;|
| Experimental: ET-01, Dose 1<br>Dose 1 of botulinum toxin, Type A, topical liniment, administered once at baseline. 250µm microneedle length | Biological: botulinum toxin, Type A<br>* ET-01 topical liniment<br>* Other names: ET-01;|
| Experimental: ET-01, Dose 2<br>Dose 2 of botulinum toxin, Type A, topical liniment, administered once at baseline. 250µm microneedle length | Biological: botulinum toxin, Type A<br>* ET-01 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 |
| --- | --- | --- |
| IGA (Investigators Global Assessment) | Investigators Global Assessment. Crow's Feet Wrinkle Scale where severity is scored between 0-4 (0=absent; 4=severe). | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IGA (Investigators Global Assessment) | Investigators Global Assessment. Crow's Feet Wrinkle Scale where severity is scored between 0-4 (0=absent; 4=severe). | Week 2, 4, 8,12, and 18 | 
| SSA (Subject Self-Assessment) | Subject Self-Assessment. Crow's Feet Wrinkle Scale where severity is scored between 0-4 (0=absent; 4=severe). | Week 2, 4, 8,12, and 18 |