Efficacy and Safety Study of RT001 for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out if an investigational drug, called RT001 Botulinum Toxin Type A Topical Gel, is safe and useful in minimizing the wrinkles between the eye and hairline called crow's feet, also known as lateral canthal lines.

Detailed Description
-----------------
RT001, a new drug, may be effective for the temporary improvement in the appearance of moderate to severe lateral canthal lines (crow's feet wrinkles) in adults. In this study, researchers want to find out if RT001is more effective than placebo gel by examining the effect on the improvement of crow's feet by both the patient and physician.

Official Title
-----------------
A Phase 2, Double-Blind, Randomized, Parallel-Group, Controlled, Multi-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 (Dose B)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent including authorization to release health information Female or male, 18 to 65 years of age and in good general health Willing and able to follow study instructions and likely to complete all study requirements Moderate to severe lateral canthal lines (crow's feet wrinkles) 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 such as Lambert-Eaton syndrome and myasthenia gravis Muscle weakness or paralysis, particularly in the area receiving study treatment Active disease or irritation at the treatment areas including the eye and the skin Pregnant, nursing, or planning a pregnancy during the study; or is a woman of childbearing potential (WOCBP) but is not willing to use an effective method of birth control Previous participation in a RT001 clinical study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 Topical Gel | Drug: Botulinum Toxin Type A<br>* RT001 (Botulinum Toxin Type A Topical Gel, Dose A) applied topically at Baseline (Day 0) to the lateral canthal lines<br>|
| Placebo Comparator: Dose B<br>Placebo Comparator | Drug: Placebo (Dose B)<br>* Placebo (Dose B), applied topically at Baseline (Day 0) to the lateral canthal lines<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of subjects who show improvement based on the investigator global and patient assessments. |  | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of subjects who show improvement based on the investigator global and patient assessments. |  | Week 8 | 

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