Itraconazole in onychomycosis. Open and double-blind studies.

Fifteen patients with onychomycosis caused by Trichophyton rubrum or T. mentagrophytes were treated with 50 mg itraconazole daily for 3 to 6 months. Fingernail infections were cured in two patients and two responded with marked improvement, e.g. small residual lesion remained and positive microscopy. The infected toenails were markedly improved in nine of 13 patients. Twenty-seven patients with T. rubrum infected nails were given 100 mg itraconazole daily for 6 to 8 months. Fingernails were cured in nine of eleven patients, while toenail infections were cured in one and markedly improved in 14 of 25 cases. Responses to 100 mg itraconazole versus 500 mg griseofulvin daily for 6 months were compared and evaluated in 20 patients with onychomycosis caused by T. rubrum or T. mentagrophytes. Fingernail infections responded equally well to both drugs with half of the cases cured or markedly improved, whereas toenails responded better to itraconazole, e.g. 4 of 9 were markedly improved versus one of 10 on griseofulvin. In patients given 50 mg itraconazole daily a significantly better response was observed in persons below 30 years of age compared to older individuals. Also, side-effects which were mainly mild and located to the gastro-intestinal tract or the central nervous system were seen less often in this group of patients on the low dose. Follow-up studies showed that cured nails remained cured, that markedly improved toenails continued to improve until cure in three of 21 patients but that aggravation took place through the one year of follow-up in more than half of the patients evaluated as markedly improved at the end of treatment.

RCT Entities:   Population Interventions Outcomes