Open-label study of the safety and efficacy of Fungoid tincture in patients with distal subungual onychomycosis of the toes.

Onychomycosis is the most frequent cause of nail diseases. An open-label study has been conducted to evaluate the safety and efficacy of Fungoid Tincture, a topical antifungal agent approved by the Food and Drug Administration for the treatment of onychomycosis of the toes. Ten patients with culture-proven distal subungual onychomycosis were treated twice daily for twelve months with topical Fungoid Tincture. Another ten patients with the same condition were treated with the vehicle alone. At monthly intervals, the target nail was trimmed, the nail bed debrided, and global clinical assessment recorded. After twelve months of therapy, all patients applying Fungoid Tincture showed negative findings on fungal culture. The vehicle alone benefitted several patients, and may have antifungal activity. Adverse effects were minimal, with mild peeling occurring in seven patients and erythema noted in one.