Open-label study of the safety and efficacy of naftifine hydrochloride 1 percent gel in patients with distal subungual onychomycosis of the fingers.

Optimal topical therapy for distal subungual onychomycosis is not available. An open-label study was performed to determine the safety and efficacy of naftifine hydrochloride (Naftin) 1 percent gel in patients with this disorder of the fingers. Ten patients with culture-proven distal subungual onychomycosis were treated twice daily for six months with naftifine hydrochloride 1 percent gel. At monthly intervals, the target nail was trimmed, the nail bed debrided, and global clinical assessment recorded. Following months three, six, and eight (two months after treatment), the target nail underwent evaluation with potassium hydroxide wet mount and fungal culture. After six months of therapy, eight of ten patients showed negative results of fungal culture and eight of ten patients showed clinical improvement. Adverse effects were minimal and included mild peeling in two patients and mild fissuring with transient fingertip numbness in one patient.