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

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 40% Urea Paste

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.

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.