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

This is an interventional treatment trial for Onychomycosis focused on measuring Bifonazole, Placebo, Urea, Nail fungus Read More

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.