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

NCT ID: NCT02580370

Last Updated: 2016-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-08-31

Brief Summary

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

Conditions

Skin Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dose A

Botulinum toxin type A

Group Type: EXPERIMENTAL

Botulinum toxin type A

Intervention Type: BIOLOGICAL

Topical botulinum toxin type A

Dose B

Placebo comparator

Group Type: PLACEBO_COMPARATOR

Placebo comparator

Intervention Type: BIOLOGICAL

Topical placebo comparator

Interventions

Botulinum toxin type A

Topical botulinum toxin type A

Intervention Type: BIOLOGICAL

Placebo comparator

Topical placebo comparator

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Revance Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Coral Gables, Florida, United States

Countries

United States

Other Identifiers

RT001-CL038

Identifier Type: -

Identifier Source: org_study_id