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 in: Journal of the American Academy of Dermatology 2018-06, Vol.78 (6), p.1156-1163
• Main Authors: Draelos, Zoe Diana, Gold, Michael H., Weiss, Robert A., Baumann, Leslie, Grekin, Steven K., Robinson, Deanne Mraz, Kempers, Steven E., Alvandi, Nancy, Weng, Emily, Berk, David R., Ahluwalia, Gurpreet
• Format: Article
• Language: English
• Subjects: Administration, Cutaneous; Adolescent; Adult; Dose-Response Relationship, Drug; Drug Administration Schedule; Erythema - diagnosis; Erythema - drug therapy; facial dermatoses; Facial Dermatoses - diagnosis; Facial Dermatoses - drug therapy; Female; Humans; Male; Middle Aged; Oxymetazoline - therapeutic use; Patient Reported Outcome Measures; Patient Safety; Prospective Studies; Rosacea - diagnosis; Rosacea - drug therapy; Severity of Illness Index; skin abnormalities; Skin Cream - administration & dosage; Time Factors; Treatment Outcome; United States; vascular skin diseases; vasoconstrictor agents; Young Adult; α-adrenergic receptors; β-adrenergic receptors
• ISSN: 0190-9622; 1097-6787
• DOI: 10.1016/j.jaad.2018.01.027

Limited treatments are available for persistent erythema of rosacea. To examine the long-term safety and efficacy of oxymetazoline cream 1.0% in patients with rosacea with moderate-to-severe persistent erythema. Patients applied oxymetazoline once daily for 52 weeks. Safety assessments included treatment-emergent adverse events (TEAEs), skin blanching, inflammatory lesion counts, telangiectasia, disease severity, and rebound effect. Efficacy was assessed by the Clinician Erythema Assessment and Subject Self-Assessment composite score at 3 and 6 hours after the dose on day 1 and at weeks 4, 26, and 52. Among 440 patients, 8.2% reported treatment-related TEAEs; the most common were application-site dermatitis, paresthesia, pain, and pruritus. The rate of discontinuation due to adverse events (mostly application-site TEAEs) was 3.2%. No clinically meaningful changes were observed in skin blanching, inflammatory lesions, or telangiectasia. At week 52, 36.7%, and 43.4% of patients achieved a 2-grade or greater composite improvement from baseline in both Clinician Erythema Assessment and Subject Self-Assessment 3 and 6 hours after a dose, respectively. Less than 1% of patients experienced a rebound effect following treatment cessation. A vehicle-control group was not included. This long-term study demonstrated sustained safety, tolerability, and efficacy of oxymetazoline for moderate-to-severe persistent erythema of rosacea.