NCT00808366

Efficacy and Safety of RV4104A Ointment in Onychomycosis

A Randomized, Parallel-Group, Multicentre, Open-Labelled, Active-Controlled Study to Assess the Efficacy, Safety and Tolerability of RV4104A Ointment Versus Bifonazole-Urea Ointment for the Complete Removal of the Clinically Infected Nail Plate Area in Patients With Toenail Onychomycosis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 228 (estimated)
• Sponsor: Pierre Fabre Dermo Cosmetique · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the efficacy of RV4104A ointment versus bifonazole-urea ointment for the complete removal of the clinically infected nail plate area in patients with toenail onychomycosis.

Conditions

• Onychomycosis

Interventions

Type	Name	Description
DRUG	Keratolytic/Antifungal	Intial treatment with RV4104A ointment for 3 weeks. Subsequent topical antifungal treatment with bifonazole cream for 8 weeks.
DRUG	Keratolytic/Antifungal	Initial treatment with bifonazole-urea ointment for 3 weeks. Subsequent topical antifungal treatment with bifonazole cream for 8 weeks.

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-06-01
• Completion: 2009-10-01
• First posted: 2008-12-15
• Last updated: 2008-12-15

Locations

1 site across 1 country: France