Safety and Efficacy Study of RT001 to Treat Moderate to Severe Lateral Canthal Lines

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of RT001 to treat moderate to severe lateral canthal lines in adults.

Detailed Description
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This multi-center study evaluates the safety and efficacy of four different doses of RT001 compared to vehicle applied as a single, bilateral topical application in at least 60 subjects with moderate to severe lateral canthal lines. Subjects will be randomized to one of the five treatment groups in a 1:1:1:1:1 ratio. Follow-up visits are scheduled through 28 days post-treatment. The safety and efficacy of Cohort 1 (through the Day 14 visit) will be assessed prior to the decision to enroll subjects into Cohort 2 if additional doses or treatment regimens need to be evaluated.

Official Title
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A Phase 2, Double-Blind, Randomized, Parallel-Group, Controlled, Dose-Ranging, Multi-Center Study to Evaluate the Safety and Efficacy of RT001, a Botulinum Toxin Type A Topical Gel, to Treat Moderate to Severe Lateral Canthal Lines in Adults.

Conditions
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Lateral Canthal Lines, Crow's Feet, Facial Wrinkles

Intervention / Treatment
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* Drug: RT001
* Drug: RT001
* Drug: RT001
* Drug: RT001
* Other: Vehicle Comparator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female or male; 30 to 55 years of age Bilateral lateral canthal lines rated as moderate or advanced Willing to refrain from receiving facial fillers, laser treatments, use of any product that affects remodeling or a product that may cause an active dermal response in the treatment area beginning at Screening through End of Study Women of childbearing potential must be practicing and willing to continue to use an effective method of birth control during the course of the study Exclusion Criteria: Muscle weakness or paralysis in the area receiving study treatment Active skin disease or irritation at the treatment areas Undergone any procedures that may affect the lateral canthal region during the past 12 months prior to Screening Previous treatment with botulinum toxin (any serotype) in the head or neck area within 9 months prior to Baseline (Day 0) Use of a topical steroid on either of the treatment areas or use of medications that suppress the immune system 30 days prior to Screening and continuing through End of Study (Day 28) Any abnormality on the electrocardiogram (ECG) at Screening or any history of clinically significant arrhythmia, unstable angina, myocardial infarction or congestive heart failure

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 55 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dose A<br>RT001 Dose A; Active Comparator | Drug: RT001<br>* RT001<br>|
| Active Comparator: Dose B<br>RT001 Dose B; Active Comparator | Drug: RT001<br>* RT001<br>|
| Active Comparator: Dose C<br>RT001 Dose C; Active Comparator | Drug: RT001<br>* RT001<br>|
| Active Comparator: Dose D<br>RT001 Dose D; Active Comparator | Drug: RT001<br>* RT001<br>|
| Placebo Comparator: Dose E<br>RT001 Dose E; Vehicle Comparator | Other: Vehicle Comparator<br>* Vehicle Comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of subjects classified as exhibiting improvement via the Investigator Global Assessment at Smile from Baseline (Day 0) to End of Study (Day 28) |  | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of subjects classified as exhibiting improvement via the Investigator Global Assessment at Rest from Baseline (Day 0) to End of Study (Day 28) |  | Day 28 | 
| Incidence of treatment-emergent AEs |  | Day 28 | 

 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, Facial Wrinkles