An open-label, noncomparative, multicenter evaluation of fluconalone with or without urea nail pedicure for treatment of onychomycosis

Fräki, Jorma E.; Heikkilä, Heikki; Kero, Matti; Kuokkanen, K; Oksman, R; Rantanen, Tapio; Saari, Seppo; Sten, Marsa L.; S, Stubb; Uggeldahl, Paul-Erik

doi:10.1016/s0011-393x(97)80040-9

Cited by 31 publications

(18 citation statements)

References 21 publications

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“…Removing the fungally infected nail plate with a 40% urea cream can indeed improve the therapeutic outcome, as has been demonstrated in the open‐label study on the treatment of onychomycosis with fluconazole with and without prior atraumatic nail removal 19 . At the end of the follow‐up period, 36 of 51 patients (71%) with nail removal and 27 of 53 (51%) were cured.…”

Section: Discussionmentioning

confidence: 73%

Action mechanisms of modern antifungal agents and resulting problems in the management of onychomycosis

Seebacher¹

2003

Mycoses

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Successful treatment of onychomycosis in the infection site depends not only on achieving the minimal inhibitory concentration (MIC) of the antifungal agent, usually determined on fresh, proliferating fungal strains, but also on the effectivity against fungal spores dormant in nail keratin. Ciclopiroxolamine and terbinafine were investigated for their fungicidal properties against proliferating and dormant dermatophyte strains. While ciclopiroxolamine was 100% effective against Trichophyton mentagrophytes (50 microg ml(-1)) and Microsporum canis (5 microg ml(-1)) both in the proliferative and dormant phase after 5 days of incubation, the same result was achieved under identical test conditions with 0.002 microg ml(-1) terbinafine using T. mentagrophytes as test organism in the proliferative and 2.0 microg ml-1 in the dormant phase. The terbinafine concentrations of 0.52 microg g(-1) measured in the nail are well below 2.0. This explains the high treatment failure and relapse rates observed under monotherapy of toenail onychomycosis even with modern antifungals. Consequently, combined therapy is recommended, beginning with atraumatic removal of the affected toenails and continuing with an antifungal nail lacquer combined with a systemic antifungal.

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Section: Discussionmentioning

confidence: 73%

Action mechanisms of modern antifungal agents and resulting problems in the management of onychomycosis

Seebacher¹

2003

Mycoses

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“… 20 In another open study in 114 patients with onychomycosis, fluconazole at the same dose (mean duration of therapy 37 weeks) achieved a mycological cure rate of 76% and a clinical cure rate of 54%. 21 A third open study reported a clinical cure rate of 72% with the same dosage and a duration of treatment of 33 weeks. 22 Fluconazole is approved for the treatment of onychomycosis in some countries (e.g.…”

mentioning

confidence: 96%

A double-blind, randomized study to compare the efficacy and safety of terbinafine (Lamisil®) with fluconazole (Diflucan®) in the treatment of onychomycosis

Havu

Heikkilä

Kuokkanen

et al. 2000

British Journal of Dermatology

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In a randomized, double-blind, double-placebo, multicentre study, terbinafine 250 mg daily for 12 weeks was compared with fluconazole 150 mg once weekly for 12 or 24 weeks in the treatment of onychomycosis. A total of 137 patients with culture-confirmed onychomycosis was divided into three groups: group A received terbinafine for 12 weeks, group B received fluconazole for 12 weeks, while group C received fluconazole for 24 weeks. At completion of the study (week 60), the mycological cure rate was higher in the terbinafine group than in the fluconazole groups: 89% vs. 51% and 49%, respectively (P < 0.001). The length of unaffected nail increased until week 24 in group B and until week 36 in group C, but was still increasing in group A at the final visit (week 60). Complete clinical cure of the target nail at week 60 was 67% in the terbinafine group, compared with 21% and 32% in the fluconazole groups, respectively. The incidence of adverse events was low for both study agents. We conclude that terbinafine 250 mg daily for 12 weeks is significantly more effective in the treatment of onychomycosis than fluconazole 150 mg once weekly for either 12 or 24 weeks.

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“…Pilot study 11 Toenail of fingernail [ [10][11][12][13][14][15][16]. The diffusion of the drug into the distal part of the nail occurs via nail bed that is further confirmed due to the presence of two foldhigher drug concentration in subungual nail material than in distal nail clippings of a patient treated for one month.…”

Section: Second Generation Oral Antifungalsmentioning

confidence: 97%

Is This the Right Drug or the Dose for the Management of Onychomycosis?

Thatai¹,

Sapra²

2017

J Cosmo Trichol

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An open-label, noncomparative, multicenter evaluation of fluconalone with or without urea nail pedicure for treatment of onychomycosis

Cited by 31 publications

References 21 publications

Action mechanisms of modern antifungal agents and resulting problems in the management of onychomycosis

Action mechanisms of modern antifungal agents and resulting problems in the management of onychomycosis

A double-blind, randomized study to compare the efficacy and safety of terbinafine (Lamisil®) with fluconazole (Diflucan®) in the treatment of onychomycosis

Is This the Right Drug or the Dose for the Management of Onychomycosis?

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