Efficacy and safety of topical oxymetazoline cream 1.0% for the treatment of facial erythema associated with rosacea: Findings from the second of 2 pivotal trials

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Conference Proceeding

Publication Date


Publication Title

J Am Acad Dermatol


Introduction: A phase 3 pivotal trial examined the efficacy and safety of oxymetazoline, a specific α1A-adrenoceptor agonist, for treatment of moderate to severe persistent facial erythema associated with rosacea.

Methods: In this multicenter double-blind trial, 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. The primary efficacy outcome was the proportion of patients with ≥2-grade decrease from baseline on Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) at 3, 6, 9, and 12 hours postdose on day 29. Safety assessments included treatment-emergent adverse events (TEAEs), inflammatory lesions, dermal tolerability, and posttreatment rebound erythema (defined as composite CEA/SSA increase of 1-grade severity from baseline).

Results: A total of 445 eligible patients (mean age: 50.3 years; 78.7% females) were randomized (oxymetazoline, n = 224; vehicle, n = 221). Most patients had moderate erythema (CEA: 84.0%; SSA: 91.5%). On day 29, the proportions of patients achieving ≥2-grade composite improvement in both CEA/SSA at 3, 6, 9, and 12 hours postdose were significantly greater with oxymetazoline vs vehicle at each time point ( P ≤ .03) and overall ( P = .001). Improvements in individual CEA and SEA components were also significantly greater with oxymetazoline vs vehicle on day 29 (overall P = .011). Incidences of TEAEs were low (oxymetazoline: 25.1%; placebo: 21.3%); most were mild or moderate in severity. The most common TEAEs with oxymetazoline and vehicle, respectively, were rosacea (3.1% [related to papules and/or pustules in all 7 patients] and 0.5% [inflammatory flare of rosacea in 1 patient]), application-site pruritus (1.8%, 1.8%), application-site dermatitis (1.8%, 0.0%), and headache (1.8%, 4.1%). Discontinuations due to TEAEs were low (oxymetazoline: 2.7%; vehicle: 0.5%). No clinically meaningful between-group differences were observed for worsening of inflammatory lesions or dermal tolerability. Following treatment cessation, low proportions of patients experienced rebound erythema (oxymetazoline: 1.2%; vehicle: 0.0%).

Conclusion: Topical oxymetazoline was safe and effective in the treatment of moderate to severe persistent facial erythema associated with rosacea. There was no apparent rebound effect following cessation of oxymetazoline treatment compared with that experienced following cessation of vehicle treatment.




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