STUDY DESIGN/DURATION Sample Clauses

STUDY DESIGN/DURATION. Study Design: This is a randomized, double-blind, vehicle-controlled, dosing ranging study. Patients will be screened and randomized to one of three PEP005 Topical Gel concentrations (0.005%, 0.01%, 0.015%) or vehicle gel for either a 2 or 3 consecutive day treatment regimen. Patients will be evaluated on the basis of safety, toleration and efficacy through 57 days following study treatment. Treatment satisfaction and QOL will also be evaluated at various timepoints throughout the study. Post-study follow-up visits will be required for all patients with unresolved, treatment-related adverse events (AEs), local skin responses (LSRs), pigmentation and/or scarring at Day 57. Study Duration: Two days study medication (Study Days 1 and 2) or three days study medication (Study Days 1, 2 and 3)