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

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Bifonazole

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.