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Objectives
The objectives of these Guidelines are to provide an overview of the fundamental disease state of rosacea and quality of life implications and outline available pharmacological treatments for rosacea with reference to supporting research and literature. The pharmacological agents discussed are inclusive of those that are FDA-approved based on phase 3 pivotal trials, commonly used agents based on extensive clinical experience, and less commonly used alternatives reported in peer-reviewed literature.
Disease State Fundamentals
A. A common facial disorder presenting most commonly in adulthood, estimated to affect approximately 14 mil lion Americans. (1), (2) The disorder is chronic and is char acterized by intermittent periods of exacerbation.

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B. Clinical signs of rosacea include central facial erythema, inflammatory lesions (papules, pustules), and telangiec tasias. (1-3)
C. The underlying cause of rosacea is unknown, however, several pathophysiological associations have been re viewed in the literature. (1), (3-6)
D. Major pathogenic components appear to be inflamma tory, vascular, and neural in origin. There is no definitive evidence that rosacea is caused by a microbial pathogen, such as a bacterium, parasite, or virus. (1), (3-6)
E. The most common clinical presentations of cutaneous rosacea include the inflammatory (papulopustular) and erythematotelangiectatic subtypes. Other presentations include phymatous rosacea (such as rhinophyma) and granulomatous rosacea. Ocular rosacea is not uncommon in patients with cutaneous rosacea; clinical presentations of ocular rosacea include conjunctivitis, blepharitis, stye formation, and keratitis. (1-3)
Quality of Life Implications
A. Rosacea has been shown to exhibit a negative impact on the quality of life. Patients affected by rosacea report ad verse psychosocial implications such as reduced self-es teemed and avoidance of social interact ion. (7), (8)
B. Effective treatment for rosacea has been correlated with marked improvement in quality of life indices. (7), (8)
Pharmacologic Treatment of Rosacea Topical Agents
Sulfacetamide 10%-Sulfur 5%
A. FDA-approved product labeling available supporting indication for rosacea treatment based on DESI drug designation.
B. Multiple randomized vehicle-controlled and comparative studies, both blinded and open-label, have con firmed efficacy and safety in patients with inflammatory rosacea measured as marked reduction in inflammatory lesions and erythema. (8-11)
C. Multiple vehicle formulations are available including cleanser, cream, gel, and topical suspension.
Metronidazole
A. Approved by the FDA for inflammatory rosacea based on phase 3 pivotal trials (double-blind, randomized, vehiclecontrolled studies).
B. Multiple blinded, split-face, and open-label vehiclecontrolled studies have been completed supporting the efficacy and safety of both topical metronidazole 0.75% and 1% formulations, including gel, cream, and lotion. (8-13)
C. Both gel and cream formulations of 1% strength are available and FDA-approved for application once daily. Three formulations of the 0.75% strength are available (including gel, lotion, and cream), which are FDA-ap proved for twice daily use.
Azelaic Acid
A. Approved by the FDA based on phase 3 pivotal trials of 15% gel formulation (double-blind, randomized, vehicle-controlled studies).
B. Efficacy and safety supported by multiple blinded and vehicle-controlled trials evaluating 15% formulation applied twice daily. (8-10), (14), (15)
Miscellaneous Topical Agents
A. Other alternative topical agents have been reported to be effective based on small studies and case reports. (8), (9)
B. Conflicting results have been reported with topical calcineurin inhibitors (tacrolimus, pimecrolimus) used for treatment of rosacea, with efficacy demonstrated in some cases and little benefit or exacerbation noted in others. (16-19)
C. Data supporting use of topical clindamycin or erythro mycin for rosacea is very limited. (9), (10) Relative lack of data compared to other available topical therapies, and concern regarding emergence of antibiotic resistance (especially with chronic use) suggest that topical eryth romycin or clindamycin are not generally recommended for treatment of rosacea.
D. Benzoyl peroxide 5%-clindamycin 1% has been shown to be effective for inflammatory rosacea. (19), (21)
E. Topical antiparasitic agents, such as permethrin, have been shown to be effective in case reports of refractory rosacea that were diagnosed as demodicidosis (Demodex folliculitis). (22), (23)
F. Topical retinoid therapy suggested as beneficial for rosacea, although supporting data is very limited. (8), (9)
Oral Agents
Anti-inflammatory Agents
A. Doxycycline 40 mg controlled-release formulation (anti inflammatory dose of doxycycline), administered as 1 capsule daily, is FDA-approved for the treatment of in flammatory rosacea in adults, based on phase 3 pivotal trials demonstrating efficacy and safety.