Clinical Trial To Evaluate ANT-1207 In Subjects With Crow's Feet

Study Overview
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Brief Summary
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The purpose of this study is to provide evidence of the safety, tolerance, and efficacy of ANT-1207 in the treatment of Crow's Feet.

Official Title
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Clinical Trial To Evaluate ANT-1207 In Subjects With Lateral Canthal Lines

Conditions
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Lateral Canthal Lines, Crow's Feet

Intervention / Treatment
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* Biological: ANT-1207
* Biological: Botulinum Toxin, Type A
* Biological: Botulinum Toxin Type A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: mild to moderate Crow's Feet wrinkles (IGA 2-3) at rest moderate to severe Crow's Feet (IGA 3-4) on contraction willingness to refrain from any product affecting skin remodeling female subjects must be not pregnant and non-lactating Exclusion Criteria: 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: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Comparator<br> | Biological: ANT-1207<br>* The interventions differ by dose of investigational product applied.<br>Biological: Botulinum Toxin Type A<br>* The interventions differ by dose of investigational product applied.<br>|
| Experimental: Dose 1<br>Dose 1 | Biological: ANT-1207<br>* The interventions differ by dose of investigational product applied.<br>Biological: Botulinum Toxin, Type A<br>* The interventions differ by dose of investigational product applied.<br>Biological: Botulinum Toxin Type A<br>* The interventions differ by dose of investigational product applied.<br>|
| Experimental: Dose 2<br>Dose 2 | Biological: ANT-1207<br>* The interventions differ by dose of investigational product applied.<br>Biological: Botulinum Toxin, Type A<br>* The interventions differ by dose of investigational product applied.<br>Biological: Botulinum Toxin Type A<br>* The interventions differ by dose of investigational product applied.<br>|
| Experimental: Dose 3<br>Dose 3 | Biological: ANT-1207<br>* The interventions differ by dose of investigational product applied.<br>Biological: Botulinum Toxin, Type A<br>* The interventions differ by dose of investigational product applied.<br>Biological: Botulinum Toxin Type A<br>* The interventions differ by dose of investigational product applied.<br>|
| Experimental: Dose 4<br>Dose 4 | Biological: Botulinum Toxin, Type A<br>* The interventions differ by dose of investigational product applied.<br>Biological: Botulinum Toxin Type A<br>* The interventions differ by dose of investigational product applied.<br>|
| Experimental: Dose 5<br>Dose 5 | Biological: Botulinum Toxin, Type A<br>* The interventions differ by dose of investigational product applied.<br>Biological: Botulinum Toxin Type A<br>* The interventions differ by dose of investigational product applied.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy will be assessed by Investigator's Global Assessment Score | Wrinkle scale with definitions of severity | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Self Assessment (SSA) scale | Change from Baseline in the Subject Self Assessment scale | 2 Weeks | 
| Investigator Global Assessment scale | Change from Baseline in wrinkle scale assessment at all other timepoints | Week 1, 2, 4, 8, 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lateral Canthal Lines, Crow's Feet