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PubMed RSS Feed - -Efficacy and Safety of Topical Oxymetazoline Cream 1.0% for Treatment of Persistent Facial Erythema Associated With Rosacea: Findings From the Two Phase 3, 29-Day, Randomized, Controlled REVEAL Trials.


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Efficacy and Safety of Topical Oxymetazoline Cream 1.0% for Treatment of Persistent Facial Erythema Associated With Rosacea: Findings From the Two Phase 3, 29-Day, Randomized, Controlled REVEAL Trials.

J Am Acad Dermatol. 2018 Jan 30;:

Authors: Stein-Gold L, Kircik LH, Draelos ZD, Werschler P, DuBois J, Lain E, Baumann L, Goldberg DJ, Kaufman J, Tanghetti EA, Alvandi N, Weng E, Berk DR, Ahluwalia G

Abstract
BACKGROUND: Rosacea is a chronic dermatologic condition with limited treatment options.
OBJECTIVE: To evaluate topical oxymetazoline cream 1.0% in patients with moderate to severe persistent erythema of rosacea.
METHODS: Data were pooled from two identically designed phase 3 trials. Patients were randomized to receive oxymetazoline 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 Assessment (CEA) and Subject Self-Assessment (SSA) at 3, 6, 9, and 12 hours postdose, day 29.
RESULTS: The pooled population included 885 patients (78.8% female); 85.8% and 91.2% had moderate erythema based on CEA and SSA, respectively. The primary outcome was achieved by significantly more patients in the oxymetazoline than vehicle group (P<0.001). Individual CEA and SSA scores and reduction in facial erythema (digital image analysis) favored oxymetazoline over vehicle (P<0.001). The incidence of treatment-emergent adverse events was low (oxymetazoline, 16.4%; vehicle, 11.8%). No clinically relevant erythema worsening (based on CEA and SSA) was observed during the 28-day posttreatment follow-up period (oxymetazoline, 1.7%; vehicle, 0.6%).
LIMITATIONS: Short-term treatment period.
CONCLUSION: Oxymetazoline effectively reduced moderate to severe persistent facial erythema of rosacea and was well tolerated.

PMID: 29409915 [PubMed - as supplied by publisher]

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