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 © 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
BACKGROUND: Brimonidine tartrate (BT) 0.5% gel demonstrated significantly greater efficacy versus vehicle gel once-daily for the treatment of moderate to severe erythema of rosacea.
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.
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Rosacea is a chronic inflammatory skin disorder that most commonly presents with transient or persistent erythema in the central facial region with additional cutaneous symptoms including telangiectasia, papules and pustules.1–4 The pathophysiology of rosacea is yet to be fully understood. It appears to be multifactorial, involving an augmented immune response and neuroimmune/neurovascular dysregulation.4,5 Vasodilation is a common underlying response in patients with erythematotelangiectatic rosacea (ETR) and papulopustular rosacea (PPR).6 Over time, repeated episodes of vasodilation and secondary inflammatory responses lead to fixed structural alterations in the cutaneous vasculature that result in persistent erythema and telangiectasia.4
Rosacea is a burden in patients with many aware that their social interactions and professional lives are affected by the condition.1 Facial erythema has been noted as the most common and debilitating manifestation of rosacea.7 Reducing facial erythema has been shown to improve levels of embarrassment and self-consciousness and increase ability to interact socially. Facial erythema, therefore, demonstrates a negative impact on patients’ quality of life.8
There has been a significant unmet need in the treatment of the facial erythema of rosacea, in terms of both efficacy and speed of response.3,6 Current systemic and topical therapies for rosacea do not generally demonstrate an onset of efficacy earlier than 3–4 weeks following commencement of treatment and do not specifically address the issue of erythema.9–12 Brimonidine tartrate (BT) is a highly selective α2-adrenergic receptor agonist with potent vasoconstrictor activity and has been shown to reverse vasodilation of both subcutaneous arteries and veins.6,13,14 BT has a well-recognized safety and efficacy record with nearly 20 years of clinical use as an ophthalmic solution for the treatment of open-angle glaucoma.13,15 Recent Phase II and III studies for once-daily topical BT 0.5% gel have confirmed its efficacy