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 determine the safety and efficacy of 2 sequential doses of RT001 compared to vehicle control following applications at Baseline (Day 0) and Week 2.

Detailed Description
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This is a double-blind, randomized, parallel-group, controlled, repeat dose, single center study to evaluate the safety and efficacy of repeat application of RT001 in at least 30 subjects with moderate to severe lateral canthal lines. Subjects will be randomized to 1 of 2 treatment groups in a 1:1 ratio (RT001 Dose A or vehicle control).

Official Title
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A Phase 2, Double-Blind, Randomized, Parallel-Group, Controlled, Repeat Dose, Single Center Study to Evaluate the Safety and Efficacy of RT001, a Botulinum Toxin Type A Topical Gel, for the Treatment of Moderate to Severe Lateral Canthal Lines In Adults

Conditions
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Lateral Canthal Lines

Intervention / Treatment
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* Other: Vehicle Control
* Drug: RT001 (Botulinum Toxin Type A Topical Gel)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female/male ages 30 to 55 Bilateral lateral canthal lines rated as moderate or advanced. Willing to refrain from any product that affects skin remodeling or a product that may cause an active dermal response in the treatment area beginning at screening through Week 6. Women of child baring potential must practice and be willing to continue to use an effective method of birth control. Exclusion Criteria: Muscle weakness or paralysis in the area receiving treatment. Active skin disease or irritation at 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 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 (Week 6). Any abnormality on the electrocardiogram (ECG) at screening or any history of clinically significant arrhythmia, unstable angina, myocardial infarction or congestive hear 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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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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>RT001 (Botulinum Toxin Type A Topical Gel) | Drug: RT001 (Botulinum Toxin Type A Topical Gel)<br>* Two sequential doses of RT001 at Baseline (Day 0) and Week 2<br>|
| Placebo Comparator: 2<br>Vehicle Control | Other: Vehicle Control<br>* Two sequential doses of Vehicle Control at Baseline (Day 0) and Week 2<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 from Baseline (Day 0) to End of Study (Week 6). |  | Baseline (Day 0) and Week 6 | 
| Incidence of treatment emergent AEs. |  | Baseline (Day 0) and Week 6 | 

 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, Lateral Canthal Area