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

Completed · Phase 3 · Has a placebo group

Conditions studied: Skin Aging

In brief

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

Key facts

Study ID: NCT02580370
Run by: Revance Therapeutics, Inc.
People needed: 450
Starts: 2015-09-01
Expected to finish: 2016-08-01
Last updated by the study team: 2016-09-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Study site — Coral Gables, Florida, United States

Full record on ClinicalTrials.gov

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