inadvertently given 10 times the assigned dose but did not report any other AEs or excessive LSRs (Table 3). Concurrent plasma concentrations were undetectable or <0.5 ng/mL. Results of laboratory evaluations, physical examinations, vital signs, and electrocardiograms were within expectations for an elderly population and were unrelated to treatment. From the Recurrence Follow-up Period, there were no treatment-related AEs or skin cancer in the treatment area.
Local Skin Reactions
LSR signs in the Phase 1 study were mostly mild-to-moderate erythema and flaking/scaling, generally appearing on day 4 and peaking ~days 5 or 8 (Cohorts 1/2) and ~days 8 or 10 (Cohorts 3/4), before spontaneously resolving/stabilizing within ~2 weeks. No participants experienced vesiculation/pustulation. No LSR required treatment.
In the Phase 2 study, even though LSRs were frequently observed with tirbanibulin ointment 1%, these were generally minimal/mild (Grade 1/2) erythema and flaking/scaling, were transient, and required no intervention. Less frequently reported were moderate (Grade 3) erythema and flaking/scaling, and minimal/mild (Grade 1/2) crusting. Only one participant (5-day cohort) had transient, severe erythema and flaking/scaling that
