It’s official. Revance Therapeutics Inc is now dosing patients for a Phase 3 pivotal study to evaluate the safety and efficacy of its RT001 investigational topical drug product candidate for the treatment of crow’s feet.
The Phase 3 trial will evaluate the safety and efficacy of a single, bilateral administration of RT001 topical gel compared to placebo in 450 patients with moderate to severe crow’s feet.
The company plans to release interim results from this Phase 3 study in the first half of 2016.
The Phase 3 trial is a randomized, double-blind, parallel-group, placebo-controlled study to evaluate the safety and efficacy of RT001, also referred to as RTT150 (Botulinum Toxin Type A) Topical Gel, for the treatment of moderate to severe lateral canthal lines. A total of up to 450 adult patients will be enrolled at multiple sites in the United States and will be randomized 1:1 to a single treatment of either RT001 topical gel or placebo. 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 2-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 1-point or greater improvement in the investigator’s and patient’s assessments. Patients will also be assessed at Day 28 for muscle paralysis using electromyography (EMG).
Revance is currently developing two Botulinum Toxin Type A investigational drug product candidates: RT001 and RT002, a novel, injectable formulation of botulinum toxin type A. Stay tuned.