January 04, 2019

The proportion of participants achieving the primary efficacy endpoint was significantly greater in the oxymetazoline group vs the vehicle group in both trial 1 and trial 2.

Oxymetazoline reduces moderate to severe persistent facial erythema associated with rosacea and is well-tolerated by users, according to a recent study published in the Journal of Drug in Dermatology.

In this study, the researchers conducted a pooled analysis of data from 2 vehicle-controlled, multicenter, double-blind, parallel-group, phase 3 trials (REVEAL; ClinicalTrials.gov Identifier: NCT02131636 and NCT02132117) conducted in the United States from 2014 to 2015.

Study participants (N=885 [440 from trial 1 and 445 from trial 2]) included adults aged 18 and older with moderate to severe persistent facial erythema of rosacea, of which 78.8% were women. Patients were randomly assigned to oxymetazoline or vehicle, which was applied topically to the face once a day for 29 days. Moderate to severe persistent facial erythema of rosacea was defined as a grade 3 or 4 on the Clinician Erythema Assessment (CEA) scale with a photonumeric guide and Subject Self-Assessment for rosacea facial redness (SSA) scale with a photo guide.

The efficacy of oxymetazoline was assessed during each clinic visit during treatment and post-treatment. Primary efficacy assessments were a ≥2-grade decrease (composite success) from baseline on both the CEA and SSA (composite score) at 3, 6, 9, and 12 hours post-dose on day 29. Secondary efficacy assessments were the proportions of patients with a ≥2-grade decrease from baseline on the individual CEA and SSA components, and digital analysis of the percent change from baseline in facial erythema at hours 3, 6, 9, and 12 on day 29.

Most participants (96.3%, 852 participants) completed the trials. The proportion of participants achieving the primary efficacy endpoint was significantly greater in the oxymetazoline group vs the vehicle group in both trial 1 and trial 2 (trial 1, P >.001; trial 2, P =.001). When pooled, the proportion of patients in the in the oxymetazoline group achieving ≥2-grade composite success on both CEA and SSA at hours 3, 6, 9, and 12 on day 29 was 13.1%, 14.4%, 16.6%, and 13.6%, respectively (P ≤.001 for each time point). Respective values in the vehicle group were 6.5%, 6.5%, 7.3%, and 6.0% (P ≤0.001 for each time point). Significantly more patients had ≥2-grade improvement from baseline over the 12-hour observation period on the CEA at day 29 (oxymetazoline group: 390 patients or 87.6%; vehicle group: 395 patients or 90.0%).

The researchers discussed one primary limitation to the 2 trials, which was its short-term treatment period despite the fact that oxymetazoline is a long-term therapy for facial erythema. Despite this limitation, the researchers highlighted the fact that oxymetazoline therapy achieved greater efficacy than and equal tolerability to the vehicle therapy. “Oxymetazoline cream 1.0% applied topically to the face once daily for 29 days effectively reduced moderate to severe erythema of rosacea and was well tolerated,” said the researchers.

Disclosures: Multiple authors declare affiliations with the pharmaceutical industry. Please refer to reference for a complete list of authors’ disclosures.

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Reference

Stein-Gold L, Kircik LH, Draelos ZD, et al. 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. J Drugs Dermatol. 2018;17(11):1201–1208.