Treatment of facial erythema in patients with rosacea with topical brimonidine tartrate: correlation of patient satisfaction with standard clinical endpoints of improvement of facial erythema. (30th July 2014)

• Record Type: Journal Article
• Authors: Fowler, J.; Tan, J.; Jackson, J.M.; Meadows, K.; Jones, T.; Jarratt, M.; Leoni, M.; the Brimonidine Phase III Study Group
• Is Part Of: Journal of the European Academy of Dermatology and Venereology. Volume 29:Number 3(2015:Mar.)
• Page Start: 474
• Page End: 481
• Publication Date: 2014-07-30
• Subjects: Dermatology -- Periodicals; Sexually transmitted diseases -- Periodicals; 616.5
• DOI: 10.1111/jdv.12587
• Languages: English
• ISSNs: 0926-9959

Abstract

<abstract abstract-type="main" id="jdv12587-abs-0001"> <title>Abstract</title> <sec id="jdv12587-sec-0001" sec-type="section"> <title>Background</title> <p>Once‐daily brimonidine tartrate (BT) 0.5% gel was shown to provide significantly greater efficacy vs. vehicle for the treatment of facial erythema in patients with rosacea.</p> </sec> <sec id="jdv12587-sec-0002" sec-type="section"> <title>Objectives</title> <p>To demonstrate that patient satisfaction with overall appearance is correlated with reduction in facial erythema, as measured by clinician and patient assessments.</p> </sec> <sec id="jdv12587-sec-0003" sec-type="section"> <title>Methods</title> <p>Data from two identical phase III, multicentre, randomized, controlled trials of moderate facial erythema of rosacea (study A: <italic>n</italic> = 260; study B: <italic>n</italic> = 293) with topical BT 0.5% compared to vehicle gel once‐daily for 4 weeks were analysed. Correlations of Patient's Assessment of Appearance (PAA) with Clinician's Erythema Assessment (CEA) and Patient's Self‐Assessment (PSA) of erythema were evaluated by calculation of gamma statistics.</p> </sec> <sec id="jdv12587-sec-0004" sec-type="section"> <title>Results</title> <p>PAA correlated with CEA post‐application on Days 1, 15 and 29 for the intent‐to‐treat population and provided a median gamma value of 0.57 (min = 0.28, max = 0.61). PAA and PSA was also highly correlated post‐application on Days 1, 15 and 29; with a median gamma value of 0.87 (min = 0.66, max = 0.89). Subjects who achieved a clinically meaningful improvement in both CEA and PSA scales were more likely to report satisfaction with the overall appearance of their skin (<italic>P</italic> < 0.001).</p> </sec> <sec id="jdv12587-sec-0005" sec-type="section"> <title>Conclusions</title> <p>Both one‐ and two‐grade improvements in facial erythema assessed by subjects (PSA) and clinicians (CEA) correlate well with PAA, a patient‐centered representation of meaningful change.</p> </sec> </abstract>