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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
260
Treatment with Amorolfine for 36 weeks
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.
Cabinet Médical
Argenteuil, France
RECRUITINGCabinet Médical
Brest, France
RECRUITINGCabinet Medical
Cholet, France
RECRUITINGCabinet Médical
Martigues, France
RECRUITINGCabinet Médical
Nice, France
RECRUITINGCabinet Médical
Toulouse, France
RECRUITINGHopital Purpan
Toulouse, France
NOT_YET_RECRUITINGTo evaluate and compare the efficacy of the sequential association RV4104A ointment-ciclopiroxolamine 1% cream-ciclopirox 8% film-forming solution versus amorolfine 5% nail lacquer alone in dermatophytic onychomycosis (toenail) without matrix involvement
Time frame: Day 336
To evaluate and compare the local tolerability of the sequential association RV4104A-ciclopiroxolamine-ciclopirox versus amorolfine 5% alone in the treatment dermatophytic onychomycosis (toenail) without matrix involvement
Time frame: Day 21, Day 77, Day 156, Day 262
To evaluate and compare the cost-effectiveness of the sequential association RV4104A ointment-ciclopiroxolamine 1% cream-ciclopirox 8% film-forming solution vs amorolfine 5% alone in the treatment of dermatophytic onychomycosis without matrix involvement
Time frame: Day 336
To evaluate and compare the clinical cure of the sequential association RV4104A ointment-ciclopiroxolamine-ciclopirox 8 versus amorolfine alone in the treatment dermatophytic onychomycosis (toenail) without matrix involvement
Time frame: Day 77, Day 168, Day 252
Averse Events Reporting
Time frame: Throughout the study
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