According to a study, researchers examined that the long-term safety and efficacy of oxymetazoline cream 1.0% in patients with rosacea with moderate-to-severe persistent erythema. Limited treatments are available for persistent erythema of rosacea. Oxymetazoline is safe and effective for the treatment of moderate-to-severe persistent erythema of rosacea. The study was published in the Journal of the American Academy of Dermatology.
Rosacea is a chronic dermatologic disease affecting approximately 16 million adults in the United States. It is characterized by centrally distributed persistent facial erythema, flushing, telangiectasia, and inflammatory papules and pustules and may progress in later stages to more severe, disfiguring forms, such as rhinophyma. For many patients, the psychosocial impact of these manifestations, as well as the clinical aspects of rosacea, are significant.
Oxymetazoline is an α1A-adrenoceptor agonist and vasoconstrictor of the cutaneous microvasculature that is US Food and Drug Administration–approved for the topical treatment of persistent facial erythema associated with rosacea in adults. This report describes findings from REVEAL Long-term, a phase 3, an open-label clinical trial designed to evaluate the safety and efficacy of 52 weeks of treatment with oxymetazoline hydrochloride cream 1.0% (oxymetazoline) for moderate-to-severe persistent facial erythema associated with rosacea.
During the 52-week treatment period, oxymetazoline applied once daily was associated with low rates of discontinuation due to AEs, a low incidence of TEAEs, and a favorable dermal tolerability profile, and it maintained efficacy in patients with persistent facial erythema associated with rosacea.
Persistent facial erythema involves a complex pathophysiology of neurovascular dysregulation, enhanced immune response, and alteration of the cutaneous vasculature. Modifications in the superficial cutaneous vasculature are regulated primarily by the sympathetic nervous system.
Oxymetazoline causes vasoconstriction primarily by activating α1A-adrenoceptors; conversely, brimonidine (Mirvaso, Galderma Laboratories, Fort Worth, TX), which is another treatment for persistent erythema of rosacea, causes vasoconstriction through α2-adrenoceptors.
The open-label design of the present study precludes application of comparative statistics to demonstrate long-term efficacy of topical oxymetazoline cream for the treatment of persistent erythema associated with rosacea. Because oxymetazoline was demonstrated to be more effective than vehicle in the REVEAL 1 and 2 trials, it is likely that similar results would be observed in a longer-term study.
Findings from this phase 3, long-term, open-label study demonstrated the safety and continued efficacy of oxymetazoline cream 1.0% for patients with moderate-to-severe persistent erythema associated with rosacea. On the basis of the overall safety profile and rigorous post-treatment follow-up, no clinically relevant rebound effect was observed.