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Sertaconazole Nitrate Cream 2% for the Treatment of Tinea Pedis

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Sertaconazole Nitrate Cream 2% for the Treatment of Tinea Pedis THERAPEUTICS FOR THE CLINICIAN Sertaconazole Nitrate Cream 2% for the Treatment of Tinea Pedis Bret M. Ribotsky, DPM Tinea pedis, both in its acute and chronic worldwide. Although tinea pedis is associated with phase, is a common skin condition that often is various complications, one of the most frequent overlooked but can lead to onychomycosis and being onychomycosis, it often is overlooked by acute bacterial cellulitis if left untreated. There- medical professionals.1 It is well-established that fore, aggressive treatment with a topical anti- Trichophyton rubrum is the predominant causative fungal agent is warranted. Sertaconazole nitrate agent of tinea pedis as well as onychomycosis. cream 2% is a newer imidazole agent that pos- According to the results of an epidemiologic sur- sesses both fungicidal and fungistatic properties veillance study conducted in the United States, to eradicate existing infections. In addition to the incidence of tinea pedis infections caused by antifungal properties, it exhibits anti-inflammatory T rubrum has steadily risen from 57% in 1999 to and antipruritic effects. Controlled clinical trials 83% in 2002. Trichophyton rubrum also was found to have confirmed its safety, tolerability, and effi- be the predominant causative agent of onychomyco- cacy in participants with tinea pedis. We report sis, with the incidence of positive cultures increasing 2 patients with chronic tinea pedis of many from 55% in 1999 to 73% in 2002.2 years’ duration and demonstrate the usefulness A growing body of data indicates that there is of sertaconazole nitrate cream 2% in the clinical a strong correlation between the presence of tinea setting. Tinea pedis was confirmed by results of pedis and onychomycosis. In one study, investigators a potassium hydroxide preparation. Both patients retrospectively reviewed the results of toenail clip- experienced marked improvement by the second pings examined histologically with periodic acid– week of twice-daily treatment with sertaconazole Schiff staining submitted over 5 years. The presence nitrate cream 2%. Clinical cure was achieved in of tinea pedis was significantly correlated with a both patients. These findings suggest that serta- histologic diagnosis of onychomycosis (P,.001).3 conazole nitrate cream 2% is an effective option Tinea pedis is considered a precursor to ony- for the treatment of tinea pedis. chomycosis.4 It appears that certain individuals are Cutis. 2009;83:274-277. genetically predisposed to develop T rubrum infec- tions based on an autosomal dominant inheritance s recently as a century ago, tinea pedis was pattern and an infection that initially begins as an uncommon clinical finding.1 Today, it tinea pedis can be transferred or extended to other A is the most common dermatophyte host body sites, such as the nails.5 Specifically, the fungus invades the horny layer of the hyponychium and/or the nail bed, then the undersurface of the nail plate. Accepted for publication March 24, 2009. 6 From Podiatric Success & Skin Care Research, Boca Raton, Afterward, the disease spreads proximally. Once Florida, and Advanced Medical & Surgical Treatment of the the nails are infected, they become reservoirs for Foot & Leg, Boca Raton, Florida. continued infection of the surrounding skin, result- This work was supported by a physician-initiated grant from Ortho ing in what can best be described as a continuum Dermatologics, a division of Ortho-McNeil-Janssen Pharmaceuticals, of reinfection.4 Inc. Dr. Ribotsky has lectured for Ortho Dermatologics. Correspondence: Bret M. Ribotsky, DPM, Advanced Medical & Appropriate diagnosis and treatment are essen- Surgical Treatment of the Foot & Leg, 880 NW 13th St, Ste 1C, tial to break this cycle. Early treatment of tinea Boca Raton, FL 33486 ([email protected]). pedis may prevent progression to onychomycosis. 274 CUTIS® Therapeutics for the Clinician Topical antifungal agents generally are con- help prevent disruption of the skin barrier function.13 sidered first-line therapy for the treatment of Pruritus is one of the symptoms of tinea pedis and tinea pedis because they usually are effective may lead to disruption of the skin barrier, allowing in eliminating dermal fungi without the need entry of foreign bacteria and potential for superinfec- for systemic therapy7 and with fewer associated tion. In addition to its anti-inflammatory activities, adverse effects.8 sertaconazole nitrate demonstrates antipruritic activ- Sertaconazole nitrate cream 2% is a newer ity. In an in vivo animal model, topical application imidazole agent that possesses both fungicidal and of sertaconazole nitrate reduced substance P–induced fungistatic properties to eradicate existing infec- itch.13 The reduction in scratching in sertaconazole- tions.9 It has a broad spectrum of activity in vitro10 treated animals was comparable to the reduction in and has been shown to be more active against scratching in hydrocortisone-treated animals. This T rubrum than fluconazole, isoconazole, keto- anti-inflammatory and antipruritic activity may alle- conazole, or miconazole, with the lowest number viate the need for corticosteroids in some patients of resistant isolates.11 After a single dose, drug and help break the itch-scratch cycle, thereby help- concentrations are maintained beyond the mini- ing to prevent spread to other body sites.13 mum inhibitory concentration for 90% of species growth for up to 48 hours.12 Sertaconazole nitrate Safety and Tolerability cream 2% contains a highly lipophilic benzothio- The safety and tolerability profile of sertaconazole phene fragment that enhances penetration into the nitrate cream 2% compares favorably with other agents stratum corneum. Substantial levels of the drug are in the topical imidazole class. In a report of 2 studies present in the skin within 30 minutes of applica- conducted in the United States with 588 participants, tion and 72% of the dose is still present 24 hours sertaconazole nitrate cream 2% was not associated after administration of a single dose, suggesting a with any serious adverse events and cutaneous adverse reservoir effect.12 events were comparable between sertaconazole-treated and vehicle-treated groups.15 Anti-inflammatory and Antipruritic Properties Inflammation associated with the lesions of tinea Clinical Efficacy pedis makes the infection more symptomatic. Sertaconazole nitrate cream 2% is indicated for the Inflammatory cytokines including tumor necrosis treatment of tinea pedis in immunocompetent patients factor a (TNF-a), IL-2, interferon-g (IFN-g), IL-4, 12 years and older. The efficacy of sertaconazole nitrate and granulocyte-macrophage colony-stimulating fac- cream 2% has been confirmed in 2 randomized, multi- tor are stimulated by fungal infections.13 These cyto- center, double-blind, parallel group, vehicle-controlled kines activate the inflammatory pathways that cause studies conducted in the United States in which par- discomfort. Antifungal agents with anti-inflammatory ticipants (N5588) were randomized to treatment with properties are desirable because they reverse mor- sertaconazole or vehicle applied twice daily for 4 weeks.15 bidity without affecting efficacy.7 Sertaconazole Sertaconazole-treated participants had significantly nitrate has been shown to inhibit the release higher rates of successful treatment outcomes, defined of the cytokines TNF-a, IL-2, IFN-g, IL-4, and as either effective clinical treatment (mycologic cure in granulocyte-macrophage colony-stimulating factor addition to marked improvement of clinical symptoms from activated human lymphocytes.13 Sertaconazole over baseline) or clinical cure (mycologic cure and nitrate was significantly more potent against the normal appearance of the skin), versus vehicle-treated release of all cytokines compared with the other participants (P,.0001). Significant reductions in the antifungal agents tested (ie, butoconazole nitrate, signs and symptoms of erythema (P,.0001), pruritus ciclopirox olamine, fluconazole, miconazole, tercon- (P5.0001), and scaling (P5.0046) were observed by azole, tioconazole, ketoconazole)(P,.05). Sertacon- investigators in participants treated with sertaconazole azole nitrate also reduced amounts of TNF-a, IL-2, nitrate cream 2% compared to the vehicle group at and IFN-g in inflamed murine tissue.13 The cellular week 4. The number of participants who reported relief mechanism by which sertaconazole nitrate exerts from pruritus, a secondary efficacy measure, increased its anti-inflammatory activity has been investigated from 20% at baseline to 77% after only 1 week of in keratinocytes and peripheral blood mononuclear therapy with sertaconazole nitrate cream 2%.15 cells, and it has been determined that sertaconazole The following case reports demonstrate the use nitrate exhibits anti-inflammatory activity via the of sertaconazole nitrate cream 2% in patients with 14 p38–cyclooxygenase 2–prostaglandin E2 pathway. tinea pedis as well as concomitant onychomycosis Sertaconazole nitrate also may inhibit the second- or a history of onychomycosis, a situation that fre- ary inflammation induced by scratching and thus quently presents in clinical practice. VOLUME 83, MAY 2009 275 Therapeutics for the Clinician A A B Figure 1. Initial examination of a 72-year-old man revealed positive signs of tinea pedis on the dorsal B aspects of the feet, including moderate scaling, hyper- keratosis, mild fissures, and interdigital maceration (A). Figure 2. Initial examination of a 68-year-old woman After 2 weeks of twice-daily
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