Clinically Relevant Reduction in Persistent Facial Erythema of Rosacea on the First Day of Treatment With Oxymetazoline Cream 1.0.

Background: Persistent facial erythema is a clinically challenging feature of rosacea. Objective: To evaluate persistent erythema reduction on the first day of treatment from pooled data from two pivotal trials of topical oxymetazoline cream 1.0% (oxymetazoline) in persistent facial erythema of rosacea. Methods: In two identically designed, phase 3, multicenter trials, adults with moderate to severe persistent facial erythema of rosacea (Clinician Erythema Assessment [CEA] grade and Subject Self-Assessment [SSA] grade >= 3) were randomized 1:1 to once-daily topical oxymetazoline or vehicle; the primary efficacy endpoint was >= 2-grade composite CEA and SSA improvement from baseline on day 29. This post hoc analysis evaluated the proportion of patients achieving >= 1-grade composite and individual CEA and SSA improvement at 1, 3, 6, 9, and 12 hours postdose on day 1 (N=885). Results: Significantly more patients achieved >= 1-grade composite and individual CEA and SSA improvement with the first application of oxymetazoline than with vehicle (P<0.001) at all postdose time points, beginning with hour 1. Day 1 safety assessments were similar between treatments. Limitations: Short-term, post hoc analysis. Conclusions: A >= 1-grade improvement in persistent erythema achieved after the first dose of once-daily topical oxymetazoline demonstrated clinically meaningful improvement from the beginning of therapy.