Pharmacy & Therapeutics - January 2009 - (Page 42) CONTINUING EDUCATION CREDIT Table 7 Non–FDA-Approved Topical Treatment of Rosacea Topical Antibiotics Clindamycin 1% lotion, gel, solution, pledget (Cleocin) Erythromycin 2% solution, ointment, pledget (Akne-Mycin) Benzoyl peroxide 5%/ clindamycin 1% (BenzaClin, Benzamycin) Sunscreen with dimethicone or cyclomethicone Benzoyl peroxide 5% and erythromycin 1% combination cream, pledget Topical Treatment Reportedly Used Effectively Azelaic acid 20% cream (Azelex) Permethrin cream 5% q.d.–q.w. (Nix) Adapalene cream, gel (Differin) Tacrolimus ointment q.d.–b.i.d. (Protopic) Pimecrolimus 1% Cream q.d.–b.i.d. (Elidel) Oxymetazoline q.d. (Afrin) Topical Treatments Theoretically Useful But Not Used Clinically Crotamiton 10% q.d.–t.i.d. (Eurax) Lindane 1% cream q.d. Benzoyl peroxide, gel, wash q.d.–b.i.d. (Benzac, Benzagel) Retinaldehyde 0.05% cream Tretinoin cream, gel (Retin-A) Tazarotene cream, gel (Tazorac, Avage) b.i.d. = twice daily; mg = milligram; q.d. = once daily; q.i.d. = four times daily; q.w. = weekly (every week). Data from Arcangelo VP, ed. Pharmacotherapeutics for Advanced Practice: A Practical Approach. Lippincott Williams & Wilkins, 2005. Sodium sulfacetamide 10% alone may also be used. Non–FDA-Approved Topical Agents When used for four to eight weeks, pimecrolimus 1% cream (Elidel, Novartis), a topical calcineurin inhibitor, was no more efficacious than the vehicle creams.21 However, in an openlabel, six-week pilot study in which patients used pimecrolimus 1% cream twice daily, nearly 50% of patients had clear skin and most showed at least modest improvement. Cutaneous adverse events, consisting of local burning, stinging, and itching occurred in fewer than 20% of patients.22 Symptomatic treatment with alpha-blockers has also been noteworthy. Patient using a topically administered selective alpha1-agonist showed a positive clinical response in treatment-resistant ETR rosacea.23 This was demonstrated as a durable improvement in the erythema, a marked decrease of erythematous flares, relief from stinging and burning, and an absence of adverse effects. It seems plausible that the erythema and flushing of ETR might result, at least in part, from an abnormal expression, function, distribution, or responsiveness of alpha-adrenergic receptors, probably of an alpha1-receptor subtype and that the topical application of agonists selective for alpha1-adrenergic receptors, such as oxymetazoline (Afrin, Schering-Plough) may be successful in treating these clinical manifestations.23 1-Methylnicotinamide 0.25% (MNA+) as a chloride salt might be a useful agent for treating rosacea.24 Applied twice daily for four weeks, improvement rated as moderate to good was observed in 26 of 34 cases; however, seven patients showed no clinical response. The presence of Demodex folliculorum may be important in the inflammatory reaction of rosacea. Crotamiton 10% cream (Eurax, Novartis in U.K.) or permethrin 5% cream (Nix, Warner-Lambert) may be useful, but these medications are rarely successful in eradicating the organism. Oral or topical ivermectin (Stromectol, Merck) may also be useful in such cases.25 Other experimental therapies include other topical antibiotics such as clindamycin and erythromycin as well as antibiotics combined with benzoyl peroxide (e.g., BenzaClin, Benzamycin, Dermik/Sanofi-Aventis). Increased strengths of azelaic acid have been used effectively, but are not yet approved by the FDA. Adapalene cream or gel (Differin, Galderma) has been used with some effectiveness as well. Treatments that should be theoretically useful based on pathogenesis of rosacea include lindane 1% cream, retinaldehyde 0.05% cream, tretinoin cream or gel (Retin-A, OrthoNeutrogena), and tazarotene cream (Tazorac, Avage, Allergan). However, these agents have not yet been reported as useful in clinical practice for treating rosacea (Table 7).14 Oral Therapy FDA-Approved Oral Agents The cornerstone of the oral treatment of rosacea involves the use of tetracyclines. Tetracycline (Sumycin) 500 mg twice a day is an effective treatment, but when it is taken with food, its absorption may be decreased. Doxycycline (Vibramycin, Pfizer) and minocycline (Minocin, Triax/Wyeth) 50–100 mg once daily to twice daily are the most currently used oral antibiotics by dermatologists for the treatment of rosacea. A new time-released form of minocycline (Solodyn, Medicis) at doses of 45, 90, and 135 mg is indicated to treat only inflammatory lesions of non-nodular, moderate-to-severe acne vulgaris in patients 12 years of age and older, but it can be used if other treatment has failed. It is the first weight-based antibiotic oral therapy for rosacea.26 Controlled-release doxycycline 40 mg (Oracea, Galderma) is effective in treating inflammatory papules and pustules, but not erythema that is associated with rosacea.27 Other reports have found this agent and dose to be a useful alternative to higher microbial doses of doxycycline.26,28 42 P&T® • January 2009 • Vol. 34 No. 1
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