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
November 2018 | Volume 17 | Issue 11 | Original Article | 1201 | Copyright © 2018
Linda Stein-Gold MD,a Leon H. Kircik MD,b Zoe Diana Draelos MD,c Philip Werschler MD FAAD FAACS,d Janet DuBois MD,e Edward Lain MD,f Leslie Baumann MD,g David J. Goldberg MD,h Joely Kaufman MD,i Emil A. Tanghetti MD,j Gurpreet Ahluwalia PhD,k,* Nancy Alvandi PhD,k,* Emily Weng ScD MBA,k David R. Berk MDk,*
aHenry Ford Health System, West Bloomfield, MI bIcahn School of Medicine at Mount Sinai, New York, NY cDermatology Consulting Services, High Point, NC dPremier Clinical Research, Spokane, WA eDermResearch, Inc, Austin, TX fAustin Institute for Clinical Research, Austin, TX gBaumann Cosmetic & Research Institute, Inc, Miami, FL hSkin Laser & Surgery Specialists of NY & NJ, New York, NY iSkin Associates & Skin Research Institute, Coral Gables, FL jCenter for Dermatology & Laser Surgery, Sacramento, CA kAllergan plc, Irvine, CA *Former employee Registry information: clinicaltrials.gov: NCT02131636 and NCT02132117
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 greater than equal to 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 less than 0.001). Individual CEA and SSA scores and reduction in facial erythema (digital image analysis) favored oxymetazoline over vehicle (P less than 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%). CONCLUSION: Oxymetazoline effectively reduced moderate to severe persistent facial erythema of rosacea and was well tolerated. J Drugs Dermatol. 2018;17(11):1201-1208.
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Rosacea, a chronic dermatologic disease characterized by persistent facial erythema, flushing, telangiectasia, and/or inflammatory papules and pustules, affects an estimated 16 million adults in the United States.1,2 Several pharmacologic agents are available to lessen the signs of rosacea; however, most reduce inflammatory lesions and possibly perilesional erythema, but offer no therapeutic benefit for persistent facial erythema.3-5Oxymetazoline hydrochloride cream 1.0% (oxymetazoline; Rhofade™, Allergan plc, Dublin, Ireland) is approved by the US Food and Drug Administration for the treatment of adults with persistent facial erythema of rosacea,4 and is an α1A-adrenoceptor agonist that causes vasoconstriction of the cutaneous microvasculature.6,7 The phase 3 clinical development program for oxymetazoline comprised 3 REVEAL trials, including two pivotal vehicle-controlled trials and a long-term open-label study, that evaluated the safety, efficacy, and tolerability of once-daily treatment with topical oxymetazoline in patients with persistent erythema of rosacea. This report describes the pooled analysis of findings from the two vehicle-controlled trials. Findings from the individual studies have been published separately.8-10