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

Windsor, NJ; Andrew Pollack, MD, Fort Washington, PA; Phoebe Rich, MD, Portland, OR; Howard Sofen, MD, Los Angeles, CA; Daniel Stewart, DO, Clinton Township, MI; Dow Stough, MD, Hot Springs AR; Jerry Tan, MD, Windsor, ON; William Werschler, MD, Spokane, WA; Patricia Westmoreland, MD, Greenville, SC. The authors wish to thank May Ma, PhD, for editorial assistance.

DISCLOSURE

The investigators received grants for conducting the studies. Ms. Rudisill and Dr. Leoni are employees of Galderma R&D. The two studies were funded by Galderma R&D.

REFERENCES

  1. Rosacea riddle now threatens more than 16 million Americans. Available at http://www.rosacea.org/weblog/2010/04/01/rosacea_incidence_on_rise/ index.php Accessed April 1, 2010.
  2. Conde JF, Yelverton CB, Balkrishnan R, Fleischer AB, Feldman SR. Managing rosacea: A review of the use of Metronidazole alone and in combination with oral antibiotics. J Drugs Dermatol. 2007;6:495-8.
  3. Wilkin J, Dahl M, Detmar M, Drake L, Liang MH, Odom R et al. Standard classification of rosacea: report of the National Rosacea Society expert committee on the classification and staging of rosacea. J Am Acad Dermatol. 2002;46:584-7.
  4. Berg M, Liden S. An epidemiological study of rosacea. Acta Derm Venereol. 1989;69:419-23.
  5. Gupta AK, Chaudhry MM. Rosacea and its management: an overview. J Eur Acad Dermatol Venerol. 2005;19:273-85.
  6. Crawford GH, Pelle MT, James WD. Rosacea: I. Etiology, pathogenesis, and subtype classification. J Am Acad Dermatol. 2004;51:327-41.
  7. Wolf JE Jr. Del Rosso JQ. The CLEAR trial: results of a large communitybased study of metronidazole gel in rosacea. Cutis. 2007;79:73-80.
  8. Aksoy B, Altaykan-Hapa A, Egemen D, Karagöz F, Atakan N. The impact of rosacea on quality of life: effects of demographic and clinical characteristics and various treatment modalities. Br J Dermatol. 2010;163:719-25.
  9. Wilkin J, Dahl M, Detmar M, Drake L, Liang MH, Odom R et al. Standard grading system for rosacea: report of the National Rosacea Society expert committee on the classification and staging of rosacea. J Am Acad Dermatol. 2004;50:907-12.
  10. Odom R, Dahl M, Dover J, Draelos Z, Drake L, Macsai M et al. Standard management options for rosacea, Part I: overview and broad spectrum of care. Cutis. 2009;84:43-7.
  11. Odom R, Dahl M, Dover J, Draelos Z, Drake L, Macsai M et al. Standard management options for rosacea, Part II: option according to subtype. Cutis. 2009;84:97-104.
  12. Singer MI. Drug therapy of rosacea: a problem-directed approach. J Cutan Med Surg. 1998; 2 (Suppl. 4):20-3.
  13. Powell FC. Rosacea. N Engl J Med. 2005;352:793-803.
  14. Wilkin JK. Rosacea: pathophysiology and treatment. Arch Dermatol. 1994;130:359-62.
  15. Del Rosso JQ. Advances in understanding and managing rosacea: part1: connecting the dots between pathophysiological mechanisms and common clinical features of rosacea with emphasis on vascular changes and facial erythema. J Clin Aesthet Dermatol. 2012;5:16-25.
  16. Steinhoff M, Buddenkotte J, Aubert J, Sulk M, Novak P, Schwab VD et al. Clinical, cellular and molecular aspects in the pathophysiology of Rosacea. J Invest Dermatol Symp Proc. 2011;15:2-11.
  17. Schwab VD, Sulk M, Seeliger S, Nowak P, Aubert J, Mess C et al. Neurovascular and neuroimmune aspects in the pathophysiology of rosacea. J Invest Dermatol Symp Proc. 2011;15:53-62.
  18. Shanler SD, Ondo AL. Successful treatment of the erythema and flushing of rosacea using a topically applied selective α1-adrenergic receptor agonist, Oxymetazoline. Arch Dermatol. 2007;143:1369-71.
  19. Wilkin JK. Effect of nadolol on flushing reactions in rosacea. J Am Acad Dermatol. 1989; 20:202-5.
  20. Craige H, Cohen JB. Symptomatic treatment of idiopathic and rosacea associated cutaneous flushing with propranolol. J Am Acad Dermatol. 2005;53:881-4.
  21. Rahman MQ, Ramaesh K, Montgomery DNI. Brimonidine for glaucoma. Expert Opin Drug Saf. 2010;9:483-91.
  22. Katz LJ. Brimonidine tartrate 0.2% twice daily vs timolol 0.5% twice daily: 1-year results in glaucoma patients. Brimonidine study group. Am J Ophthalmol. 1999;127:20-6.
  23. Serle JB. A comparison of the safety and efficacy of twice daily brimonidine 0.2% versus betaxolol 0.25% in subjects with elevated intraocular pressure. The brimonidine study group III. Surv Ophthalmol. 1996; 41 (Suppl 1):S39-47.
  24. Fowler J, Jarratt M, Moore A, Meadows K, Pollack A, Steinhoff M et al. Oncedaily topical brimonidine tartrate gel 0.5% is a novel treatment for moderate to severe facial erythema of rosacea: results of two multicenter, randomized and vehicle-controlled studies. Br J Dermatol. 2012; 166(3): 633-41.
  25. Graf P. Long-term use of oxy- and xylometazoline nasal sprays induces rebound swelling, tolerance, and nasal hyperreactivity. Rhiology 1996;34:9-13.
  26. Adkins JC, Balfour JA. Brimonidine. A review of its pharmacological properties and clinical potential in the management of open-angle glaucoma and ocular hypertension. Drugs Aging. 1998;12:225-41.
  27. Schuman JS, Horwitz B, Choplin NT, David R, Albracht D, Chen K. A 1-year study of brimonidine twice daily in glaucoma and ocular hypertension. A controlled, randomized, multicenter clinical trial. Arch Ophthalmol. 1997;115:847-52.

AUTHOR CORRESPONDENCE

Joseph Fowler Jr. MDfowlerjoe@msn.com
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