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 (ONICO)

Inclusion Criteria:

• Clinical diagnosis of distal-lateral or lateral subungual onychomycosis of one great toenail (the target nail) without matrix involvement
• Target nail plate showing between 25% and 60% of clinically infected area
• Patient must have at least 2 mm of unaffected proximal target nail area
• Target nail infection due exclusively to a dermatophyte (from positive fungal culture as reported by the central mycological laboratory)
• Female patient of childbearing potential must use an efficient contraceptive method for at least 2 months prior to screening visit
• Female patient of childbearing potential must have a negative urinary pregnancy test at the screening visit

Exclusion Criteria:

• Patient with more than 3 affected nails
• Patient with onychomycosis with matrix involvement
• Patient with psoriasis, lichen planus or other abnormalities that could result in clinically abnormal toenail(s)
• Patient with moccasin-type tinea pedis
• Patient who has received systemic antifungal therapy or any topical antifungal therapy applied to the toenails within 3 months prior to screening visit
• Patient with known hypersensitivity to investigational products' ingredient(s)
• Patient who is currently participating or who has participated in another clinical study within 4 weeks prior to screening visit