Efficacy of 4 weeks topical bifonazole treatment for onychomycosis after nail ablation with 40% urea: a double-blind, randomized, placebo-controlled multicenter study

Hans-Juergen Tietz, Roderick Hay, Susanne Querner, Andreas Delcker, Peter Kurka, Hans F. Merk*

*Corresponding author for this work

    Research output: Contribution to journalArticlepeer-review

    21 Citations (Scopus)

    Abstract

    Onychomycosis is a common fungal infection most often affecting the toenails. If untreated, it can cause discomfort sufficient to reduce quality of life. To evaluate efficacy and safety of bifonazole cream vs. placebo in onychomycosis treatment after non-surgical nail ablation with urea paste. Fifty-one study centres randomized 692 subjects with mild-to-moderate onychomycosis to receive bifonazole 1% cream or placebo for 4weeks following non-surgical nail ablation with urea 40% paste over 2-4weeks. Efficacy of the two phase treatment was evaluated by overall cure of the target nail comprising clinical and mycological cure 2weeks, 3 and 6months after end of treatment. At 2weeks (primary endpoint), overall cure rate was superior in bifonazole-treated group (54.8% vs. 42.2% for placebo; P=0.0024). The clinical cure rate was high in both treatment groups (86.6% bifonazole vs. 82.8% placebo), but proportion with mycological cure was higher with bifonazole treatment (64.5%) vs. placebo treatment 49.0%, (P=0.0001). We observed higher early overall cure rate with 4weeks topical bifonazole compared with placebo after removal of infected nail parts with urea. This two stage treatment was well tolerated and offers an additional option in topical onychomycosis therapy.

    Original languageEnglish
    Pages (from-to)414-421
    Number of pages8
    JournalMycoses
    Volume56
    Issue number4
    DOIs
    Publication statusPublished - Jul 2013

    Keywords

    • Onychomycosis
    • bifonazole
    • nail ablation
    • urea
    • nail disorder
    • antifungal treatment
    • INTERDIGITAL TINEA-PEDIS
    • TOENAIL ONYCHOMYCOSIS
    • TREATMENT OPTIONS
    • CLOTRIMAZOLE
    • COMBINATION
    • TERBINAFINE
    • OINTMENT
    • DISEASE
    • SAFETY
    • RATES

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