Patient-rated symptom assessment for rosacea facial redness (SARFR): Results of two phase 3 pivotal trials of oxymetazoline cream 1% vs vehicle

Introduction: Limited topical pharmacological treatments are available for persistent erythema associated with rosacea. Two phase 3 pivotal trials examined the efficacy and safety of oxymetazoline, a specific α1A-adrenoceptor agonist, for treatment of moderate to severe persistent facial erythema associated with rosacea. This report describes Symptom Assessment for Rosacea Facial Redness (SA RFR) data from both trials; primary efficacy and safety results were reported separately. Methods: In 2 identically designed trials, eligible patients were randomized 1:1 to receive vehicle or oxymetazoline hydrochloride cream 1.0% (oxymetazoline) applied topically to the face once daily for 29 days. Severity of erythema associated with rosacea was evaluated using the 4-item SA-RFR, a validated, patient-rated scale with higher scores indicating greater symptom severity (0, no symptoms; 4, most severe symptoms). In both trials, patients completed the SA-RFR at baseline and at hours 3, 6, 9, and 12 postdose on day 29. Response outcomes were evaluated as change from baseline in SA RFR overall symptom score (all 4 items) and domains of skin appearance (items 1-2) and skin sensations (items 3-4). Between-group comparisons of oxymetazoline vs vehicle were made using the Wilcoxon rank sum test (statistical significance, P<.05). Results: SA-RFR assessments included 440 patients in study 1 (oxymetazoline, n = 222; vehicle, n = 218) and 441 patients in study 2 (oxymetazoline, n = 222; vehicle, n = 219). For at least 1 time point on day 29, significantly greater improvements from baseline were observed for oxymetazoline vs vehicle in SA-RFR overall symptom severity scores (study 1, P =.03; study 2, P<.04). Similarly, significantly greater improvements from baseline were observed for oxymetazoline vs vehicle in the domain of skin appearance at all time points assessed on day 29 (study 1, P ≤ .004; study 2, P ≤ .011). Treatment with oxymetazoline vs vehicle resulted in numerically greater improvements from baseline in the SA-RFR domain of skin sensations on day 29, but differences were not statistically significant. Conclusion: Patients with moderate to severe persistent facial erythema associated with rosacea treated with oxymetazoline once daily for 29 days consistently reported greater improvements in overall rosacea symptoms, specifically those associated with persistent facial erythema, vs patients who received vehicle.