Efficacy and Safety of RV4104A Ointment in Onychomycosis

Inclusion Criteria: * Clinical diagnosis of distal-lateral or lateral subungual onychomycosis of one great toenail (the target nail) * Target nail plate showing ≥ 12.5% of clinically infected area * Patient must have at least 2 mm of the proximal end of the target nail free of infection * Target nail infection due exclusively to a dermatophyte (from both positive direct microscopy examination and positive fungal culture as reported by the central mycological laboratory) Exclusion Criteria: * Patient with more than 2 affected toenails * 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 topical antifungal nail lacquer within 3 months or any other topical antifungal therapy applied to the feet or toenails within 2 months prior to screening visit