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A double-blind, randomized, multicenter, placebo-controlled phase 3 trial to prove the superiority of bifonazole vs. placebo after 4 weeks of onychomycosis treatment (as a follow-up of a 2 weeks treat...

Mise à jour : Il y a 4 ans
Référence : EUCTR2008-003215-13

A double-blind, randomized, multicenter, placebo-controlled phase 3 trial to prove the superiority of bifonazole vs. placebo after 4 weeks of onychomycosis treatment (as a follow-up of a 2 weeks treatment of non-surgical nail ablation of diseased nail matrix with a 40% urea paste)

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Extrait

The primary objective of the trial is to demonstrate superiority of bifonazole vs. placebo after 28 days of onychomycosis treatment as a follow-up of non-surgical nail ablation with a 40% urea paste over 14 days (in rare cases up to 28 days) by assessing complete cure (mycological and clinical cure) 2 weeks after the end of treatment (visit 3)

Critère d'inclusion

  • Mild to moderate onychomycosis of fingernail(s) or toenail(s)

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