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

Phase 3

Completed

• Conditions: Skin Aging
• Interventions: Biological: Placebo comparator; Biological: Botulinum toxin type A

• Registration Number: NCT02580370
• Lead Sponsor: Revance Therapeutics, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-10-15
• Study First Submitted QC: 2015-10-19
• Study First Posted: 2015-10-20
• Primary Completion: 2016-07
• Study Completion: 2016-08
• Status Verified: 2016-09
• Disposition First Submitted: 2016-09-07
• Disposition First Submitted QC: 2016-09-07
• Last Update Submitted: 2016-09-07
• Disposition First Posted: 2016-09-09
• Last Update Posted: 2016-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose B	Placebo comparator	Placebo comparator
Dose A	Botulinum toxin type A	Botulinum toxin type A

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Investigator Global Assessment with 2 points or greater improvement from baseline	Week 4	Proportion of subjects with 2 points or greater improvement from baseline using the Investigator Global Assessment
Patient Severity Assessment with 2 points or greater improvement from baseline	Week 4	Proportion of subjects with a 2 point or greater improvement from baseline using the Patient Severity Assessment
Patient Severity Assessment with 1 points or greater improvement from baseline	Week 4	Proportion of subjects with a 1 point or greater improvement from baseline using the Patient Severity Assessment
Investigator Global Assessment with 1 point or greater improvement from baseline	Week 4	Proportion of subjects with 1 point or greater improvement from baseline using the Investigator Global Assessment