NCT00781820

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 693 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Onychomycosis

Interventions

Type	Name	Description
DRUG	Bifonazole cream 1%	1 squeeze of Bifonazole cream sufficient to cover the infected nail bed(s) with a thin layer once daily for 28 days after nail ablation with urea paste
DRUG	Placebo cream	1 squeeze of Placebo cream sufficient to cover the infected nail bed(s) with a thin layer once daily for 28 days after nail ablation with urea paste

Timeline

• Start date: 2008-10-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2008-10-29
• Last updated: 2013-06-11

Locations

51 sites across 3 countries: Czechia, Germany, Poland