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Antimicrobial Activity of Iodoquinol 1%– Hydrocortisone Acetate 2% Gel Against Ciclopirox and Clotrimazole

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Antimicrobial Activity of Iodoquinol 1%– Hydrocortisone Acetate 2% Gel Against Ciclopirox and Clotrimazole THERAPEUTICS FOR THE CLINICIAN Antimicrobial Activity of Iodoquinol 1%– Hydrocortisone Acetate 2% Gel Against Ciclopirox and Clotrimazole Bruce P. Burnett, PhD; Calvin M. Mitchell Commercially available topical formulations acteria, fungi, and yeast may co-colonize and consisting of iodoquinol 1%–hydrocortisone ace- contribute to the pathophysiology of a vari- tate 2%, ciclopirox 0.77%, and clotrimazole 1%– B ety of dermatoses, including intertrigo, tinea betamethasone dipropionate 0.5% were assessed pedis, tinea cruris, tinea corporis, tinea capitis, for their antimicrobial activity against cultures of tinea versicolor, and onychomycosis.1,2 In the absence Micrococcus luteus, Propionibacterium acnes, of a culture, differential diagnosis of bacterial and methicillin-resistant Staphylococcus aureus (MRSA), fungal infections can be challenging and can result Pseudomonas aeruginosa, Corynebacterium aquaticum, in unresolved infections following initial therapy. Trichophyton mentagrophytes, Malassezia furfur, Therefore, the use of broad-spectrum topical agents Microsporum canis, Candida albicans, Trichophyton may be particularly useful for treating intertrigo; rubrum, or Epidermophyton floccosum. At 1 and other mixed infections, such as dermatophytosis com- 5 minutes following inoculation into suspensions of plex; and dermatoses at risk for infection. each product, aliquots were removed, serially diluted, A variety of common fungi, normally innocu- and plated onto appropriate agar to determine the ous on the skin, can produce serious infections, log reduction in colony-forming units (CFUs) for each especially in immunocompromised individuals. organism. Iodoquinol 1% produced the broadest Trichophyton rubrum is the most prevalent dermato- and greatest antimicrobial activity as measured by a phyte on the human body, accounting for approxi- 3-log reduction of CFU, active against all microbes mately 80% of the incidence of tinea pedis and tested following incubation times of 1 or 5 minutes, onychomycosis.3-7 Trichophyton mentagrophytes also is except M luteus. By contrast, ciclopirox 0.77% and a common cause of tinea pedis, tinea corporis, and clotrimazole 1% showed activity against P aeruginosa sometimes superficial onychomycosis.3,4 This der- and T rubrum, with ciclopirox also killing M luteus, matophyte generally is more resistant to antifungal P acnes, M canis, C albicans, and E floccosum at treatments (eg, ketoconazole, bifonazole) compared 5 minutes. Iodoquinol 1%–hydrocortisone acetate 2% with T rubrum.8 Both strains also have shown resis- also was the only product that showed effective anti- tance to griseofulvin and fluconazole.9,10 Microsporum bacterial reduction of MRSA at 1 minute. canis is primarily found in cats and dogs. In humans, Cutis. 2008;82:273-280. M canis is the principle cause of tinea corporis and tinea capitis.11 Sometimes M canis produces myce- Accepted for publication June 5, 2008. tomalike lesions in immunocompromised hosts. From Primus Pharmaceuticals, Inc, Scottsdale, Arizona. M canis has shown resistance to fluconazole, which This work was supported by an educational grant from Primus has been associated with up-regulation of the Pharmaceuticals, Inc. Dr. Burnett is an employee of Primus ubiquitin gene, Ub, similar to T mentagrophytes.12 Pharmaceuticals, Inc. Mr. Mitchell is an employee and stockholder Epidermophyton floccosum causes tinea pedis, tinea of Primus Pharmaceuticals, Inc. 7,13 Correspondence: Bruce P. Burnett, PhD, Primus Pharmaceuticals, cruris, tinea corporis, and onychomycosis. Infec- Inc, 4725 N Scottsdale Rd, Suite 200, Scottsdale, AZ 85251 tion occurs primarily in nonliving cornified layers of ([email protected]). the epidermis, though a small number of invasive VOLUME 82, OCTOBER 2008 273 Therapeutics for the Clinician infections have been observed in immunocom- With the possibility of coinfection and the use of promised patients.14 Malassezia furfur causes tinea gross examination as the first and possibly only diag- versicolor, found most commonly on the neck, nostic criterion of skin conditions, it is necessary back, and chest, and less frequently on the face to use a broad-based antifungal and antibacterial and scalp.15 Immunocompromised patients are par- agent with a lower-potency steroid to avoid sup- ticularly susceptible to infection in tissue folds. The pression of skin immunity. Iodoquinol (and related azoles and terbinafine showed limited effectiveness 8-hydroxyquinolines) and ciclopirox olamine are against Malassezia species, including M furfur, while 2 agents that have shown efficacy against a wide amphotericin B generally demonstrated better kill- range of bacteria and fungi in clinical studies or in ing effects.16 Candida albicans, a common and gen- vitro kill testing.20,32,33 Despite widespread use of erally noninfectious bacterium in more than 80% iodoquinol as a topical anti-infective, data dem- of the population worldwide, can cause thrush in onstrating its killing activity against bacteria and immunocompromised patients.17 C albicans exhibits fungi in vitro are limited. To compare the anti- resistance to fluconazole, amphotericin B, and vori- infective potency of commonly used antifungal conazole.18,19 Although most azole-type compounds agents in vitro, log reduction kill tests were con- produce good clinical resolution and mycologic ducted using commercially available topical prepa- conversion of individual fungal species in skin infec- rations of iodoquinol 1%–hydrocortisone acetate 2%, tions, they show limited effectiveness against a wide ciclopirox 0.77%, and clotrimazole 1%–betamethasone variety of fungi. The antibacterial activity of azole dipropionate 0.5% on a variety of pathogenic bac- compounds is limited, generally confined to gram- teria, fungi, and yeast responsible for common positive organisms.20 skin infections. Bacteria are known to adapt and develop anti- biotic resistance quickly under selective pressure Material and Methods in both laboratory settings and patient populations Test Products and Microorganisms—The anti-infective in which a high level of antibiotics is being used. test products were all prescription products: iodo- Propionibacterium acnes is present in skin acne,21 quinol 1%–hydrocortisone acetate 2% gel (each Corynebacterium aquaticum is a causative agent in gram contains 20 mg of hydrocortisone acetate, meningitis and urinary tract infections,22-24 and 10 mg of iodoquinol, and 10 mg of aloe poly- Micrococcus luteus generally is a nonpathogenic saccharide in purified water, carbopol, magnesium organism associated with endocarditis22,25; each aluminum silicate, PPG-20 methyl glucose ether, is found in healthy individuals and all have been aminomethyl propanol, propylene glycol, glycerine, found to be resistant to both tetracycline and benzyl alcohol, SD alcohol 40-B, biopeptide, hydro- erythromycin.21-24 Pseudomonas aeruginosa infec- chloric acid, FD&C blue 1, and FD&C yellow 10); tions frequently cause increased morbidity and ciclopirox 0.77% (each gram contains 7.70 mg of mortality in hospitalized and immunocompromised ciclopirox olamine in a water-miscible vanishing patients.26 This organism increasingly has been cream base consisting of purified water USP, cetyl associated with urinary tract infections, particu- alcohol NF, mineral oil USP, octyldodecanol NF, stea- larly with the use of catheters, and has been ryl alcohol NF, cocamide DEA, polysorbate 60 NF, found to be intrinsically resistant to ampicillin, myristyl alcohol, sorbitan monostearate NF, lactic most cephalosporins, and macrolides because of an acid USP, and benzyl alcohol NF [1%] as preserva- impermeable outer membrane and the ability to tive); and clotrimazole 1%–betamethasone dipropio- actively transport the antibiotic out of the cell.27 nate 0.5% (each gram contains 10 mg of clotrimazole P aeruginosa also has shown resistance to gentamicin, and 0.64 mg of betamethasone dipropionate [equiva- tobramycin, and amikacin sulfate.28 Currently, one lent to 0.5 mg of betamethasone] in a hydrophilic of the more insidious bacterial infections with cream consisting of purified water, mineral oil, white potentially deadly effects is caused by Staphylococcus petrolatum, cetearyl alcohol 70/30, ceteareth-30, aureus. Methicillin-resistant S aureus (MRSA), origi- propylene glycol, sodium phosphate monobasic, and nally found primarily in hospital or chronic care phosphoric acid, as well as benzyl alcohol as a preser- settings, more recently has occurred in community- vative). All of the topical products were purchased based settings.29 It has been shown that the most from a retail pharmacy. common sites of MRSA infection are skin and soft All microorganisms were purchased from tissue, accounting for 80% to 90% of all infections.30 American Type Culture Collection (ATCC®). Often originating from skin inoculation,31 MRSA is The bacterial strains used were M luteus (ATCC 1 of the 2 most frequent causes of bacteremia and car- No. 10240b), P acnes (ATCC No. 6919), ries a high rate of morbidity and mortality. S aureus (MRSA) (ATCC No. 700698), 274 CUTIS® Therapeutics for the Clinician P aeruginosa (ATCC No. 15691), and C aquaticum Data Analysis and Antimicrobial Threshold—The (ATCC No. 14665). The strains of fungi used were standard 99.9% (3 log) decrease in the initial inocu- T mentagrophytes (ATCC No. 10270), M furfur lum was used as a threshold for anti-infective com- (ATCC No. 44338), M canis (ATCC No. 10214), pounds to be considered bactericidal and fungicidal C albicans
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