INTRODUCTION
Rosacea is a common inflammatory skin disorder estimated to affect 16 million Americans.1 Although it is usually observed in patients with light skin phototype, rosacea has also been diagnosed in patients with darker skins.2-4 Persistent erythema is the primary feature of rosacea and presents ubiquitously among rosacea patients.3 In addition, other cutaneous signs such as telangiectasia, papules, and pustules may also be present.5,6 Several topical and oral medications are currently approved for the treatment of papules and pustules of rosacea, including metronidazole, azelaic acid and anti-inflammatory dose doxycycline.7,8 However, there is currently no approved medication for the treatment of erythema of rosacea, making it a key unmet medical need.9
Brimonidine tartrate (BT), a highly selective α2-adrenergic receptor agonist, was recently shown to reduce erythema of rosacea when applied topically.10,11 BT possibly acts through its vasoconstrictive activity,12-15 leading to a constriction of the abnormal dilation of facial blood vessels in patients presenting with erythema.16-18 BT ophthalmic solution has been approved for the treatment of open-angle glaucoma, with a well-documented good safety profile.12,19,20 The efficacy and safety of topical BT gel 0.5% were assessed in previous randomized, double-blind and controlled Phase II and pivotal Phase III studies, in which BT gel 0.5% was applied once daily for 4 weeks.10, 11 The results demonstrated that topical BT gel 0.5% provided significantly greater efficacy and a faster onset of action compared to the vehicle gel, with a good overall safety profile. In the present long-term study, we aimed to evaluate the safety and efficacy of topical BT gel 0.5% when the medication is applied once daily for up to 12 months.
MATERIALS AND METHODS
The long-term safety and efficacy of the once daily BT gel 0.5% were evaluated in this open-label study carried out in 27 centers in the United States. This study was conducted in accordance with the ethical principles originating from the Declaration of Helsinki and Good Clinical Practices and in compliance with lo-