Topical oxymetazoline cream 1.0% for persistent facial erythema associated with rosacea: Pooled analysis of the two phase 3, 29-day, randomized, controlled reveal trials

Background: Rosacea is a chronic dermatologic condition with limited treatment options. Methods: Data were pooled from two identically designed phase 3 trials. Patients with moderate to severe persistent erythema of rosacea were randomized to receive oxymetazoline cream 1.0% or vehicle once daily for 29 days and were followed for 28 days posttreatment. The primary efficacy outcome was the proportion of patients with ≥2-grade improvement from baseline on both Clinician ^Erythema Results: The ^Assessment pooled population ^{(CEA) and} included ^Subject 885 ^{Self-Assessment} patients ^Do(78.8% ^{Not (SSA)} female); ^{at 3,Copy 6} 85.8% ^{9, and} and ¹² 91.2% ^{hours postdose} had moderate ^{day 29.} erythema based on CEA and ^SSA Individual _{The incidence} ^{respectively.} CEA _of and _{treatment-emergent} ^The SSA ^primary scores ^outcome and reduction _adverse ^was _Penalties ^achieved in _events facial _was ^by erythema ^{significantly} _{low (oxymetazoline} (digital ^more image _Apply ^patients analysis) _16.4%; ^{in the} _vehicle favored ^{oxymetazoline} _11.8%). oxymetazoline _No ^than _clinically ^vehicle over _relevant vehicle ^group (^(P P _erythema ^<0.001). <0.001). worsening (based on CEA and SSA) was observed during the 28-day posttreatment follow-up period (oxymetazoline, 1.7%; vehicle, 0.6%). Conclusion: Oxymetazoline effectively reduced moderate to severe persistent facial erythema of rosacea and was well tolerated.