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

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of 2 sequential doses of RT001 compared to placebo gel to treat moderate to severe lateral canthal lines in adults.

Detailed Description
-----------------
This is a double-blind, randomized, parallel-group, controlled, repeat dose, single center study to evaluate the efficacy and safety of a repeat application of RT001 compared to placebo gel in at least 36 subjects with moderate to severe lateral canthal lines (LCL). Subjects will be randomized to 1 of 2 treatment groups in a 1:1 ratio (active versus placebo). At least 36 adult volunteers who have provided informed consent and have met the study eligibility criteria will be enrolled. There will be 18 subjects in each treatment group.

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

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

Intervention / Treatment
-----------------
* Drug: Botulinum Toxin Type A
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female or male, 30 to 60 years of age Bilateral lateral canthal lines rated as moderate or severe Willing to refrain from receiving facial fillers, laser treatments, use of any product that affects skin remodeling or a product that may cause an active dermal response in the treatment area beginning at Screening and 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: Any neurological condition that may place the subject at increased risk with exposure to Botulinum Toxin Type A, including peripheral motor neuropathic diseases such as amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional disorders Muscle weakness or paralysis in the area receiving study treatment Active skin disease or irritation at the treatment areas Eyelid ptosis, excessive dermatochalasis, deep dermal scarring or inability to substantially lessen the lateral canthal lines to be treated by physically spreading them apart Use of prescription retinoid products during the past 3 months prior to Screening Chemical peel (medium depth or deeper) during the past 9 months prior to Screening Undergone any procedures that may affect the lateral canthal region such as: periorbital surgery, brow lift or related procedures, laser skin resurfacing or soft tissue augmentation (upper half of face) during the past 12 months prior to Screening Screening electrocardiogram (ECG) that is abnormal or clinically significant or any history of hypokalemia, torsade de pointe, unstable angina, myocardial infarction or congestive heart failure or family history of prolonged QT Previous treatment with Botulinum Toxin Type A in the face area Previous treatment with greater than 200 U Botulinum Toxin Type A anywhere else in the body within the last 6 months prior to Screening Concurrent use of aminoglycoside antibiotics, or other agents that might interfere with neuromuscular transmission starting at Screening 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 Clinically significant laboratory values at Screening

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

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 | Drug: Botulinum Toxin Type A<br>* RT001 (Botulinum Toxin Type A Topical Gel) Dose A applied topically at Baseline (Day 0) and at Week 4 on the lateral canthal areas<br>|
| Placebo Comparator: Dose B<br>Placebo | Drug: Placebo<br>* Placebo (Dose B) applied topically at Baseline (Day 0) and at Week 4 on the lateral canthal areas<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of subjects classified as exhibiting improvement via the Investigator Global Assessment of Lateral Canthal Line-Rest Severity Scale of the LCA at Baseline compared to Week 8; incidence of treatment emergent AEs |  | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of subjects classified as exhibiting improvement via the Investigator Global Assessment of Lateral Canthal Line Severity at Smile and at Rest from Baseline to Weeks 2, 4, 6, 8; incidence of treatment emergent AEs |  | Weeks 2, 4, 6, 8 | 

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