Phase III Results of Topical Brimonidine for Rosacea Released

Topical brimonidine tartrate gel 0.5% (Galderma, www.galderma.com) is significantly more efficacious than vehicle in the treatment of rosacea-related erythema. Joseph Fowler, MD, et al, have published the findings of two phase III pivotal trials on brimonidine in the Journal of Drugs in Dermatology(June 2013). The multicenter, randomized, double-blind, parallel-group studies included 260 subjects and 293 subjects, respectively, and were carried out between May 2011 and November 2011. In both studies half of the patients used topical vasoconstrictor brimonodine tartrate gel 0.5% once daily for four weeks, the other half of patients used vehicle only. The subjects were evaluated on days 1, 15 and 29 of the treatment period and again at four weeks post-treatment. The majority of subjects were female, Fitzpatrick skin type II.
The endpoint profile of success was defined as a two-grade improvement in Clinician’s Erythema Assessment (CEA) and Patient’s Self-Assessment (PSA). The researchers reported that “Topical brimonidine tartrate gel 0.5% was significantly more efficacious than vehicle throughout 12 hours on days 1, 15 and 29, with significant difference observed as early as 30 minutes after the first application on day 1.” There was no clinically meaningful rebound of erythema seen during the followup phase. Adverse events were greater among the treated groups, but events were reported as dermatological, mild and transient nature. The FDA is slated to complete its review of brimonidine during the second half of 2013.