The study is focused to prove that the efficacy of a 1% Bifonazole cream is superior to a placebo cream after non-surgical nail ablation with a 40% urea paste.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
693
1 squeeze of Bifonazole cream sufficient to cover the infected nail bed(s) with a thin layer once daily for 28 days after nail ablation with urea paste
1 squeeze of Placebo cream sufficient to cover the infected nail bed(s) with a thin layer once daily for 28 days after nail ablation with urea paste
Overall cure rate comprising clinical cure and mycological cure microscopy + culture negative
Time frame: 14 days after end of treatment (=visit 3)
Clinical cure rate
Time frame: 14 days, 3 and 6 months after end of treatment (=visit 3, 4, and 5)
Culture negative
Time frame: 14 days, 3 and 6 months after end of treatment (=visit 3, 4, and 5)
Microscopy negative
Time frame: 14 days, 3 and 6 months after end of treatment (=visit 3, 4, and 5)
Relapse rate (overall cure at visit 3 but positive clinical or mycological findings at visit 4
Time frame: 3 and 6 months after end of treatment (=visit 4 and 5)
Mycological cure rate (microscopy + culture negative)
Time frame: 3 and 6 months after end of treatment (=visit 4 and 5)
Culture negative
Time frame: 6 months after end of treatment (=visit 5)
Incidence of adverse events
Time frame: 2 weeks, 3 and 6 months after end of treatment (=visit 3, 4, and 5)
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Chomutov, Czechia
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Hlinsko, Czechia
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Kutná Hora, Czechia
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Louny, Czechia
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Olomouc, Czechia
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Prague, Czechia
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Rychnov nad Kněžnou, Czechia
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Slaný, Czechia
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Svitavy, Czechia
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Ústí nad Labem, Czechia
...and 41 more locations