Improvement in Facial Erythema Within 30 Minutes of Initial Application of Brimonidine Tartrate in Patients With Rosacea
June 2014 | Volume 13 | Issue 6 | Original Article | 699 | Copyright © June 2014
J. Mark Jackson MD,a Joseph Fowler 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, San Francisco, CA
gGalderma R&D, Princeton, NJ
OBJECTIVES: To assess the 30-minute speed of onset of topical BT 0.5% gel in reducing facial erythema in Phase III studies as measured by subject and clinician assessments of erythema.
METHODS: Two Phase III, randomized, controlled studies with identical design in which subjects with moderate erythema of rosacea (study A: n=260; study B: n=293) were randomized 1:1 to apply topical BT 0.5% or vehicle gel once-daily for 4 weeks. Evaluations included severity of erythema based on Clinician’s Erythema Assessment (CEA) and Patient’s Self-Assessment (PSA) prior to study drug application and at 30 minutes after application on days 1, 15, and 29.
RESULTS: 97.7% and 96.6% of subjects reported normal study completion for studies A and B, respectively. The percentage of subjects achieving a 1-grade improvement in both CEA and PSA was significantly increased at 30 minutes post-dosing with BT 0.5% gel compared to vehicle gel on visit days (day 1: 27.9 vs 6.9%, P<0.001; day 15: 55.9 vs 21.1%, P<0.001; Day 29: 58.3 vs 32.0%, P<0.001 for BT 0.5% gel vs vehicle) in study A. Similar results were shown for study B.
CONCLUSIONS: Once-daily topical BT gel 0.5% is not only efficacious at reducing facial erythema but also exhibits response within 30 minutes of application in a significant number of patients throughout both Phase III studies.
J Drugs Dermatol. 2014;13(6):699-704.