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The U.S. Food and Drug Administration approved brimonidine tartrate gel 0.5% g (BT) for the treatment of the erythema associated with erythematotelangiectatic rosacea. Consistent with its action as a highly selective α2-adrenergic receptor agonist, BT constricts blood vessels after application to skin. A previous, seminal study showed rapid reduction of redness scores lasting at least 12 hours. (NEJM JW Dermatol Nov 11 2011).
Now, a group of investigators at 27 sites report the safety and efficacy of BT applied once-daily for 1 year by 449 subjects with rosacea and moderate-to-severe erythema. Patients with papulopustular rosacea were not disqualified. Concomitant treatment with topical metronidazole or azelaic acid, or systemic tetracycline, doxycycline, or minocycline was permitted. Patients were seen eight times over the year. Adverse effects were evaluated by patient responses and assessments of vital signs, intraocular pressure, blood count, blood chemistry, urinalysis, and physical examination. Erythema, telangiectases were also assessed, and inflammatory lesion counts and patient questionnaires were conducted.
Treatment-related adverse effects included flushing (in 9%), worsening of erythema (7%), worsening of rosacea (4%), burning sensation (3%), irritation (3%), contact dermatitis (2%), and pruritus (2%). Most adverse effects were of mild or moderate severity. No disturbing trends towards abnormal laboratory tests or abnormal vital signs were detected. Mean severity of erythema scores decreased throughout the study. Mean erythema scores 3 hours after application of BT were consistently lower than at 1 hour after application. The mean number of inflammatory lesions decreased, but only slightly.
Moore A et al. Long-term safety and efficacy of once-daily topical brimonidine tartrate gel 0.5% for the treatment of moderate to severe facial erythema of rosacea: Results of a 1-year open-label study. J Drugs Dermatol 2014 Jan 1; 13:56.
Comment
This study shows the utility and safety of brimonidine tartrate gel used in an outpatient setting to treat typical moderate-to-severe erythematotelangiectatic rosacea, with or without coexisting papules and pustules. It does not appear to be effective as monotherapy for papules and pustules, nor does it seem to prevent them. Perhaps erythema does not cause papules or pustules, as some experts have suggested. However, applications were just once a day, so erythema may have recurred each night. Erythema decreased even after just one application. The blanching effect was more obvious 3 hours after application than after 1 hour. Tachyphylaxis was not seen. Average use rate was about one-half gram per application.