In an open study 58 patients with chronic
dermatophytosis mainly caused by Trichophyton rubrum and five patients with
Tinea capitis were treated with
ketoconazole. The indications were ineffectiveness of or side effects to
griseofulvin. Response to treatment varied from 1 week in scalp
infections to 11 weeks in toe-nail lesions.
Dermatophytosis of hands and feet were cured in 25%, marked improvement observed in further 30%. Toe- and finger-nail
infections were cured in 20% and 43%, respectively, and marked improvement seen in further 36% and 14%, respectively. All scalp
infections were cured without relapse. Recurrence of
infections before 6 months
after treatment was seen in 55-60% of hand and foot lesions and 33-38% of finger and toe-nail
infections. In a double-blind study 20 patients with
onychomycosis caused by T. rubrum the efficacy of
ketoconazole was compared to that of
griseofulvin. Cure rates in the
griseofulvin group were 25% for finger-nails and zero for toe-nails, while 50% and 57% experienced marked improvement. In the
ketoconazole group, 25% of finger-nail
infections were cured and 75% markedly improved, while the corresponding figures for toe-nails were 11% and 89%, respectively. Adverse reactions to
ketoconazole were seen in 29 (46%) of the patients in the open study and in 2 (20%) in the double-blind study and comprised mainly minor complaints. Side effects caused discontinuation in 12 patients, in two of whom due to
toxic hepatitis.