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

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.

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