Comparative Efficacy of Bifonazole Cream vs Placebo After Nail Ablation With Urea Paste

Launched by BAYER · Oct 28, 2008

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Eligibility criteria

• Inclusion Criteria:
• • Age of at least 18 years;
• • Positive clinical findings of onychomycosis according to the judgement of the investigator (e.g. thickening, discoloration, structural changes, misshaped nails);
• • Positive mycological findings (positive microscopy and positive culture with identification of pathogen) in material taken from affected nail sites before the start of treatment;
• • Nail mycosis with an affected nail area between 20% and 50% in the target nail,
• • Nail mycosis in not more than 3 nails (each nail not more than 50% infected area)
• Exclusion Criteria:
• • Doubtful or negative mycological findings;
• • Proximal subungual onychomycosis (PSO);
• • Topical antimycotic treatment of feet or hands within 4 weeks prior to screening, topical treatment of onychomycosis of feet or hands within 12 weeks prior to screening;
• • Systemic antimycotic treatment within 12 weeks prior to screening;
• • Failure to treat tinea pedis/manus (diagnosed at screening) successfully with topical treatment between screening visit and visit 1 (baseline);
• • Tinea pedis/manus at visit 1 (baseline);
• • Uncontrolled diabetes mellitus
• • Psoriasis
• • Peripheral arterial disease
• • Chronic venous insufficiency;
• • Diabetic neuropathy;
• • History of hypersensitivity to bifonazole, or any other similar pharmacological agents or components of the products;
• • Known sensitivity to plasters.