Efficacy and Safety of Once-Daily Topical Brimonidine Tartrate Gel 0.5% for the Treatment of Moderate to Severe Facial Erythema of Rosacea: Results of Two Randomized, Double-blind, and Vehicle-Controlled Pivotal Studies

June 2013 | Volume 12 | Issue 6 | Original Article | 650 | Copyright © June 2013


Joseph Fowler Jr. MD,a J. Mark Jackson MD,a Angela Moore MD,b Michael Jarratt MD,c Terry Jones MD,d Kappa Meadows MD,e Martin Steinhoff MD,f Diane Rudisill BSc,g and Matthew Leoni MDg on behalf of the Brimonidine Phase III Study Group

aUniversity of Louisville, Louisville, KY bArlington Center for Dermatology, Arlington, TX cDermResearch, Inc, Austin, TX dJ&S Studies, Inc, College Station, TX eThe Education & Research Foundation, Inc, Lynchburg, VA fUniversity of California at San Francisco, San Francisco, CA gGalderma R&D, Princeton, NJ

table 2
versus vehicle gel in both studies on day 29 (both P<.001; ITT analyses). The success rate with BT gel 0.5% at Hours 3, 6, 9, and 12 was 31.5%, 30.7%, 26.0%, and 22.8% in study A, and 25.4%, 25.4%, 17.6%, and 21.1% in study B (vs 10.9%, 9.4%, 10.2%, and 8.6% in study A and 9.2%, 9.2%, 10.6%, and 9.9% in study B for the vehicle gel; Figure 2). Significant difference between BT gel 0.5% and vehicle gel on the profile of success was also confirmed by PP analyses and three different sensitivity analyses in both studies (all P<.05).
table 3
Efficacy was also evaluated based on the 1-grade improvement on both CEA and PSA, which represents a clinically relevant effect that is noticeable by both clinicians and patients. In study A, the responder rate of BT gel 0.5% was significantly greater than that of vehicle gel (P<.001) on day 29, with 70.9%, 69.3%, 63.8%, and 56.7% of subjects in the BT gel 0.5% group having 1-grade improvement on both CEA and PSA at Hours 3, 6, 9, and 12, respectively (vs 32.8%, 32.0%, 29.7%, and 30.5% for vehicle gel; Figure 3). A significant difference between the two groups was also observed on day 29 in study B, with a responder rate of 71.1%, 64.8%, 66.9%, and 53.5% in the BT gel 0.5% group at Hours 3, 6, 9, and 12, respectively (versus 40.1%, 43.0%, 39.4%, and 40.1% for vehicle gel; P<.001).
Onset of action of BT gel 0.5% was evaluated based on the 30-minute effect, defined as the 1-grade improvement on CEA, and PSA 30 minutes after the drug application on day 1. In both studies, significantly greater effect was observed with BT gel 0.5% compared with vehicle gel (both P<.001). In study A, 27.9% of subjects in the BT gel 0.5% group had 1-grade improvement on CEA and PSA at 30 minutes on day 1, compared with 6.9% in the vehicle gel group (Figure 4). In study B, 28.4% of subjects in the group of BT gel 0.5% and 4.8% of subjects in the group of vehicle gel demonstrated the 30 minutes effect. This significant and more rapid onset of action of BT gel 0.5% versus vehicle gel was also confirmed in PP analyses.
Superiority of BT gel 0.5% over vehicle gel was observed in terms of profile of success throughout both studies, with statistically significant differences observed on days 1 and 15, as well as day 29 (all P<.001). Similarly, BT gel 0.5% was also significantly more
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