NCT01014637

Efficacy, Safety and Cost-effectiveness of a Sequential Therapy With RV4104A Ointment, Ciclopiroxolamine Cream and Ciclopirox Film-forming Solution Compared With Amorolfine Nail Lacquer in Dermatophytic Onychomycosis

A Multicentre, Randomized, Controlled Study of the Efficacy, Safety and Cost-effectiveness of a Sequential Therapy With RV4104A Ointment, Ciclopiroxolamine Cream and Ciclopirox Film-forming Solution Compared With Amorolfine Nail Lacquer Alone for the Treatment of Dermatophytic Onychomycosis (Toenail) Without Matrix Involvement

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 260 (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 and compare the efficacy of the sequential association RV4104A ointment followed by ciclopiroxolamine 1% cream and ciclopirox 8% film-forming solution versus amorolfine 5% nail lacquer alone in the treatment of patients with dermatophytic onychomycosis (toenail) without matrix involvement.

Conditions

• Onychomycosis

Interventions

Type	Name	Description
DRUG	Amorolfine (Antifungal)	Treatment with Amorolfine for 36 weeks
DRUG	RV4104A, Ciclopiroxolamine, Cyclopirox (Keratolytic Agents/Antifungal)	Initial treatment with RV4104A ointment for 3 weeks, followed by treatment with ciclopiroxolamine 1% cream for 8 weeks and by cyclopirox 8% film-forming solution for 25 weeks.

Timeline

• Start date: 2009-08-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2009-11-17
• Last updated: 2009-11-17

Locations

7 sites across 1 country: France