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Once-daily topical brimonidine tartrate gel 0·5% is a novel treatment for moderate to severe facial erythema of rosacea: results of two multicentre, randomized and vehicle-controlled studies

2011; Oxford University Press; Volume: 166; Issue: 3 Linguagem: Inglês

10.1111/j.1365-2133.2011.10716.x

1365-2133

Joseph F. Fowler, Michael Jarratt, Angela Moore, Kappa P. Meadows, Austin Pollack, Martin Steinhoff, Y. Liu, Matthew Leoni,

Dermatology and Skin Diseases

British Journal of DermatologyVolume 166, Issue 3 p. 633-641 THERAPEUTICS Once-daily topical brimonidine tartrate gel 0·5% is a novel treatment for moderate to severe facial erythema of rosacea: results of two multicentre, randomized and vehicle-controlled studies J. Fowler, J. Fowler University of Louisville, Louisville, KY, U.S.A.Search for more papers by this authorM. Jarratt, M. Jarratt DermResearch, Inc., Austin, TX, U.S.A.Search for more papers by this authorA. Moore, A. Moore Arlington Center for Dermatology, Arlington, TX, U.S.A.Search for more papers by this authorK. Meadows, K. Meadows The Education & Research Foundation, Inc., Lynchburg, VA, U.S.A.Search for more papers by this authorA. Pollack, A. Pollack Philadelphia Institute of Dermatology, Fort Washington, PA, U.S.A.Search for more papers by this authorM. Steinhoff, M. Steinhoff University of California at San Francisco, San Francisco, CA, U.S.A.Search for more papers by this authorY. Liu, Y. Liu Galderma R&D, Princeton, NJ, U.S.A.Search for more papers by this authorM. Leoni, M. Leoni Galderma R&D, Princeton, NJ, U.S.A.Search for more papers by this authoron behalf of the Brimonidine Phase II Study Group, on behalf of the Brimonidine Phase II Study GroupSearch for more papers by this author J. Fowler, J. Fowler University of Louisville, Louisville, KY, U.S.A.Search for more papers by this authorM. Jarratt, M. Jarratt DermResearch, Inc., Austin, TX, U.S.A.Search for more papers by this authorA. Moore, A. Moore Arlington Center for Dermatology, Arlington, TX, U.S.A.Search for more papers by this authorK. Meadows, K. Meadows The Education & Research Foundation, Inc., Lynchburg, VA, U.S.A.Search for more papers by this authorA. Pollack, A. Pollack Philadelphia Institute of Dermatology, Fort Washington, PA, U.S.A.Search for more papers by this authorM. Steinhoff, M. Steinhoff University of California at San Francisco, San Francisco, CA, U.S.A.Search for more papers by this authorY. Liu, Y. Liu Galderma R&D, Princeton, NJ, U.S.A.Search for more papers by this authorM. Leoni, M. Leoni Galderma R&D, Princeton, NJ, U.S.A.Search for more papers by this authoron behalf of the Brimonidine Phase II Study Group, on behalf of the Brimonidine Phase II Study GroupSearch for more papers by this author First published: 02 November 2011 https://doi.org/10.1111/j.1365-2133.2011.10716.xCitations: 112 Joseph Fowler. E-mail: fowlerjoe@msn.com Funding sources The two studies were funded by Galderma R&D. Conflicts of interest The investigators received grants for conducting the studies. Y.L. and M.L. are employees of Galderma R&D. ClinicalTrials.gov registration numbers: NCT00989014, NCT01174030. Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat Summary Background Erythema of rosacea is thought to result from abnormal cutaneous vasomotor activity. Brimonidine tartrate (BT) is a highly selective α2-adrenergic receptor agonist with vasoconstrictive activity. Objective To determine the optimal concentration and dose regimen of topical BT gel for the treatment of erythema of rosacea and to evaluate its efficacy and safety. Methods In study A, 122 subjects were randomized to receive a single application of BT 0·07%, 0·18%, 0·5% or vehicle. In study B (4-week treatment and 4-week follow-up), 269 subjects were randomized to receive BT 0·5% once daily, BT 0·18% once daily, vehicle once daily, BT 0·18% twice daily or vehicle twice daily. Evaluations included Clinician’s Erythema Assessment (CEA), Patient’s Self-Assessment (PSA), Chroma Meter measurements and adverse events. Results In study A, a single application of topical BT gel reduced facial erythema in a dose-dependent fashion. A significant difference between BT 0·5% and vehicle in Chroma Meter redness value was observed from 30 min to 12 h after application. In study B, BT 0·5% once daily had a statistically superior success profile (defined as a two-grade improvement on both CEA and PSA over 12 h) compared with vehicle once daily on days 1, 15 and 29 (all P < 0·001). No tachyphylaxis, rebound of erythema or aggravation of other disease signs (telangiectasia, inflammatory lesions) was observed. All regimens were safe and well tolerated with similarly low incidence of adverse events. Conclusions Once-daily BT gel 0·5% is well tolerated and provides significantly greater efficacy than vehicle gel for the treatment of moderate to severe erythema of rosacea. Citing Literature Volume166, Issue3March 2012Pages 633-641 RelatedInformation