Topical oxymetazoline cream 1.0% is safe and effective for long-term treatment of moderate to severe persistent facial erythema associated with rosacea, according to the results of the 52-week, phase 3, multicenter, open-label REVEAL trial (ClinicalTrials.gov identifier: NCT02095158), conducted at 25 centers in the United States and published in the Journal of the American Academy of Dermatology.
Study participants completed 6 visits throughout the trial: baseline and weeks 4, 12, 26, 39, and 52. Throughout the 52-week study period, patients applied a pea-sized amount of the medication in a thin layer that covered the entire face, including the forehead, cheeks, nose, and chin, at the same time every morning.
Safety assessments included treatment-emergent adverse events, which were recorded at each study visit; mean change from baseline in inflammatory lesion counts; telangiectasia, rated on a 5-point scale, using the Clinician Telangiectasia Assessment; and evaluation of inflammatory lesions of rosacea, rated on a 5-point scale, using the Investigator’s Global Assessment of Disease Severity. In addition, application site skin blanching, rated on a 5-point scale, and dermal tolerability (including patient-rated stinging/burning and pruritus, as well as investigator-rated scaling and dryness) were scored from 0 (none) to 3 (severe).
Efficacy was evaluated by the proportion of patients achieving clinical response, defined as a 2-grade or higher improvement from baseline on Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) composite scores at 3 and 6 hours postdose on day 1, as well as at 4, 26, and 52 weeks. Worsening of erythema from baseline after treatment cessation was assessed by change in CEA and SSA composite scores, and individual scores from moderate (3) to severe (4).
Eligible patients included adults ≥18 years of age with moderate to severe persistent facial erythema of rosacea, which was defined as grade 3 or higher on the CEA scale with a photonumeric guide and SSA for rosacea facial redness scale with a photo guide.
Overall, among a total of 440 participants, 8.2% reported treatment-emergent adverse events, including application site dermatitis, paresthesia, pain, and pruritus. No clinically meaningful changes were reported in skin blanching, inflammatory lesions, or telangiectasia. At 52 weeks, 36.7% and 43.4% of participants achieved a 2-grade or higher composite improvement from baseline in both CEA and SSA, respectively. Overall, <1% of patients experienced a rebound effect after treatment cessation.
The investigators concluded that this long-term study demonstrated sustained efficacy, safety, and tolerability of topical oxymetazoline for patients with severe, persistent rosacea-associated facial erythema.
Draelos ZD, Gold MH, Weiss RA, et al. Efficacy and safety of oxymetazoline cream 1.0% for treatment of persistent facial erythema associated with rosacea: findings from the 52-week open label REVEAL trial [published online January 30, 2018]. J Am Acad Dermatol. doi: 10.1016/j.jaad.2018.01.027