controlled, 92 female gel Single effect was superior to multicentre, 45.7 years dose. vehicle gel and consistently dose finding dose dependent with the study. highest concentration (0.5%) being the most effective. Safety and tolerability were good and comparable between the groups treated the brimonidine tartrate gel and vehicle gel. 18161 Randomised, 269 Brimonidine Brimonidine tartrate 0.5% double blind, subjects tartrate (0.5% gel was statistically parallel group, 52 male, q.d., 0.18% q.d. superior to vehicle gel for vehicle 217 female or b.i.d.) gel or the primary endpoint. No controlled, 44.3 vehicle gel evidence of tachyphylaxis multicentre, (q.d. or b.i.d.). was observed. All efficacy and brimonidine tartrate gel safety study. concentrations/regimens were well-tolerated with an acceptable safety profile during the treatment and follow up phases. ROSE-201 Outpatient, 110 Brimonidine This previous study randomised, subjects tartrate 0.2%, provided supportive data double blind, 27 male 83 0.07%, 0.02% on the efficacy of vehicle female or vehicle gel brimonidine tartrate gel in controlled, 47.6 years Applied each the treatment of erythema parallel group, morning and of rosacea. However the multicentre as needed interpretation was limited study. thereafter but as brimonidine tartrate no more than 0.5% gel was not used and once every 4 the endpoints evaluated hours and no were different to those used more than 3 in the pivotal studies. times per day for 28 days. Based on the Phase IIb study results and additional data from previous studies, brimonidine tartrate 0.5% gel applied once daily was an appropriate concentration and dose regimen selected for the Phase III program. Efficacy Studies providing efficacy data Pivotal efficacy studies Study 18140, was, a Phase III multicentre, randomised, double blind, parallel group, vehicle controlled pivotal study. The main objective of the study was to demonstrate the efficacy of brimonidine tartrate 0.5% gel, applied topically q.d. for 4 weeks versus
controlled, multicentre, dose finding study. 92 female 45.7 years gel Single dose. effect was superior to vehicle gel and consistently dose dependent with the highest concentration (0.5%) being the most effective. Safety and tolerability were good and comparable between the groups treated the brimonidine tartrate gel and vehicle gel. 18161 Randomised, double blind, parallel group, vehicle controlled, multicentre, efficacy and safety study. 269 subjects 52 male, 217 female 44.3 Brimonidine tartrate (0.5% q.d., 0.18% q.d. or b.i.d.) gel or vehicle gel (q.d. or b.i.d.). Brimonidine tartrate 0.5% gel was statistically superior to vehicle gel for the primary endpoint. No evidence of tachyphylaxis was observed. All brimonidine tartrate gel concentrations/regimens were well-tolerated with an acceptable safety profile during the treatment and follow up phases. ROSE-201 Outpatient, randomised, double blind, vehicle controlled, parallel group, multicentre study. 110 subjects 27 male 83 female 47.6 years Brimonidine tartrate 0.2%, 0.07%, 0.02% or vehicle gel Applied each morning and as needed thereafter but no more than once every 4 hours and no more than 3 times per day for 28 days. This previous study provided supportive data on the efficacy of brimonidine tartrate gel in the treatment of erythema of rosacea. However the interpretation was limited as brimonidine tartrate 0.5% gel was not used and the endpoints evaluated were different to those used in the pivotal studies. Based on the Phase IIb study results and additional data from previous studies, brimonidine tartrate 0.5% gel applied once daily was an appropriate concentration and dose regimen selected for the Phase III program. Efficacy Studies providing efficacy data Pivotal efficacy studies Study 18140, was, a Phase III multicentre, randomised, double blind, parallel group, vehicle controlled pivotal study. The main objective of the study was to demonstrate the efficacy of brimonidine tartrate 0.5% gel, applied topically q.d. for 4 weeks versus
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