Specialty biopharmaceutical company Revance Therapeutics has commenced dosing patients in the Phase 3 pivotal study to evaluate the safety and efficacy of its RT001 investigational topical product candidate for the treatment of crow’s feet. Revance plans to release interim results in the first half of 2016.
The randomized, double-blind, parallel-group, placebo-controlled study is designed to determine the safety and efficacy of a single, bilateral administration of RT001 topical gel in patients with moderate to severe crow’s feet. A total of up to 450 adult patients will be enrolled at multiple sites in the U.S. and will be randomized 1:1. The product will be applied to lateral canthal lines on both sides of the face using Revance’s proprietary applicator.
The primary efficacy endpoints are composites based upon the Investigator’s Global Assessment of Lateral Canthal Lines (IGA-LCL) assessment and the Patient Severity Assessment (PSA) between baseline and 28 days after treatment. One composite endpoint includes those patients with a two-point or greater improvement as graded by the investigator’s assessment and the patient’s self-assessment. The other composite endpoint includes those patients who experience a one-point or greater improvement in the investigator’s and patient’s assessments. Subjects will also be assessed at Day 28 for muscle paralysis (or paralytic effect) using electromyography (EMG).
“Transporting large molecules, such as botulinum toxin, through the skin has the potential to offer many clinical benefits. We anticipate it will be easier for medical professionals to administer a topical product and that patients will be able to avoid the pain, bruising and downtime associated with needles,” said Dan Browne, president and CEO of Revance.
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