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Novel and emerging pharmacotherapy and device-based treatments for onychomycosis
Published in Robert Baran, Dimitris Rigopoulos, Chander Grover, Eckart Haneke, Nail Therapies, 2021
Jose W. Ricardo, Shari R. Lipner
Luliconazole is an imidazole antifungal that decreases ergosterol synthesis by inhibiting lanosterol demethylase. It has activity against dermatophytes and nondermatophyte molds (NDMs). A cream formulation was approved by the USA FDA since 2013, and in Japan since 2005 for the treatment of superficial mycoses, including tinea pedis; it is not approved for the treatment of onychomycosis. In vitro, it was shown to have higher potency than amorolfine, ciclopirox, and topical terbinafine against dermatophytes. It has a high molecular weight, which hinders penetrance through the nail plate; however, a modified molecular structure with reduced keratin affinity allows the drug to be readily released from the nail plate’s keratin matrix, thereby enhancing nail permeability. A randomized vehicle-controlled phase III study of onychomycosis patients aged 21–79 years with 20–50% nail involvement was conducted to assess efficacy of luliconazole 5% nail solution. After 48 weeks, 14.9% of patients treated with luliconazole 5% solution applied once daily achieved complete cure compared with vehicle (5.1%, P = 0.012). Luliconazole-treated patients also showed significantly higher rates of mycological cure compared with vehicle (45.4% versus 31.2%, P = 0.026). Adverse reactions associated with luliconazole were mostly localized, and mild or moderate, including dry skin (6.7%), contact dermatitis (5.2%), paronychia (4.1%) and eczema (3.1%). Therefore, once-daily application of luliconazole 5% solution is clinically effective and well tolerated.
Monographs of Topical Drugs that Have Caused Contact Allergy/Allergic Contact Dermatitis
Published in Anton C. de Groot, Monographs in Contact Allergy, 2021
Luliconazole is an azole and dichlorobenzene antifungal agent. Its mechanism of action is as a cytochrome P450 2C19 inhibitor, altering the synthesis of fungal cell membranes. Luliconazole is indicated for the topical treatment of fungal infections caused by Trichophyton rubrum and Epidermophyton floccosum, specifically tinea pedis, cruris, and corporis.
Emerging drugs for the treatment of onychomycosis
Published in Expert Opinion on Emerging Drugs, 2019
Several novel topical treatments are being investigated and are in phase I-III trials. Luliconazole was originally approved in 2013 in the United States for fungal infections of the skin, such as tinea pedis. This azole has several properties that make it an effective fungicide, such as low minimum inhibitory concentration, low systemic bioavailability, and rapid nail plate penetration [43]. In a recent Japanese multicenter, double-blind, randomized phase III study, adult patients were allocated into 2:1 groups of once-daily application of luliconazole 5% nail solution or vehicle. After the 48-week treatment, the complete cure rates were much higher in the luliconazole groups (14.9%) than vehicle (5.1%, p = 0.012). Additionally, negative direct microscopy rates were higher in the drug group (45.4%) than vehicle (31.2%, p = 0.026) – thus, once daily application of topical luliconazole is thought to be clinically effective [38].
Nanotechnological interventions in dermatophytosis: from oral to topical, a fresh perspective
Published in Expert Opinion on Drug Delivery, 2019
Riya Bangia, Gajanand Sharma, Sunil Dogra, Om Prakash Katare
This antifungal drug is found to have one to four times lower Minimum inhibitory concentration (MIC) than terbinafine against T. rubrum and T. mentagrophytes [40]. It is reported that luliconazole 1% holds potential of eradicating dermatophytic infections caused by T. mentagrophytes in an experimental model and it takes half the time or less than that required by terbinafine 1% and bifonazole 1% creams [41]. This potential drug was given approval by the FDA in November 2013 for the therapy of tinea pedis, tinea corporis, and tinea cruris [40]. Topical application of 1% luliconazole, once daily for 7 days, is recommended for tinea cruris and tinea corporis and for 14 days in case of tinea pedis over the affected site.
Safety of current therapies for onychomycosis
Published in Expert Opinion on Drug Safety, 2020
Jose W. Ricardo, Shari R. Lipner
Luliconazole has a favorable safety profile. In an open-label study of 24 luliconazole-treated patients with distal subungual onychomycosis, there was one case of mild skin erythema that resolved spontaneously, and no reports of systemic side effects or drug–drug interactions[105]. Furthermore, luliconazole showed high bioavailability in the nail plate for an extended period of time (up to 7 days after the last application)[105]. Luliconazole is labeled as pregnancy category C due to the lack of adequate and well-controlled studies in pregnant women. It is not known whether luliconazole is excreted into human milk. Thus, it should be avoided during pregnancy and breastfeeding.