Safety and Efficacy of Botulinum Toxin Type A Topical Gel for Lateral Canthal Lines

Study Overview
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Brief Summary
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This is a safety and efficacy study of botulinum toxin type A in subjects with lateral canthal lines.

Conditions
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Skin Aging

Intervention / Treatment
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* Biological: Botulinum toxin type A
* Biological: Placebo comparator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: In good general health Moderate to severe lateral canthal lines when evaluated at rest based on the investigator's global assessment Moderate to severe lateral canthal lines when evaluated at rest based on the patient assessment of severity Exclusion Criteria: Any neurological condition that may place the subject at increased risk with exposure to botulinum toxin type A such as amyotrophic lateral sclerosis and motor neuropathy, Lambert-Eaton syndrome, and myasthenia gravis Muscle weakness or paralysis, particularly in the area receiving study treatment Active skin disease or irritation or disrupted barrier at the treatment area Active eye disease or irritation Eyelid ptosis, excessive dermatochalasis, deep dermal scarring, or inability to substantially effect the LCL to be treated by manually spreading the skin apart Use of topical prescription retinoid product(s) in the lateral canthal areas during the 3 months prior to Screening Undergone any procedures that may affect the lateral canthal region during the 12 months prior to Screening Treatment with botulinum toxin type A in the lateral canthal areas in the 6 months prior to Screening or 3 months anywhere else in the body

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Experimental: Dose A<br>Botulinum toxin type A | Biological: Botulinum toxin type A<br>* Topical botulinum toxin type A<br>|
| Placebo Comparator: Dose B<br>Placebo comparator | Biological: Placebo comparator<br>* Topical placebo comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite endpoint based upon the investigator global assessment (IGA-LCL) and patient assessment of severity (PSA) of lateral canthal lines |  | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Global Assessment with 2 points or greater improvement from baseline | Proportion of subjects with 2 points or greater improvement from baseline using the Investigator Global Assessment | Week 4 | 
| Investigator Global Assessment with 1 point or greater improvement from baseline | Proportion of subjects with 1 point or greater improvement from baseline using the Investigator Global Assessment | Week 4 | 
| Patient Severity Assessment with 2 points or greater improvement from baseline | Proportion of subjects with a 2 point or greater improvement from baseline using the Patient Severity Assessment | Week 4 | 
| Patient Severity Assessment with 1 points or greater improvement from baseline | Proportion of subjects with a 1 point or greater improvement from baseline using the Patient Severity Assessment | Week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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REALISE 1