Preventive effects of topical washing with miconazole nitrate-containing soap to diaper candidiasis in hospitalized elderly patients: A prospective, double-blind, placebo-controlled study.

The objective of the present randomized, double-blind trial was to evaluate the efficacy and safety of daily washing with miconazole nitrate-containing soap for candidiasis at diaper-covered sites in elderly subjects under long-term inpatient care. To confirm the onset and disappearance of candidiasis, we microscopically evaluated the existence of the pseudohyphae and/or blastoconidia of Candida spp. We enrolled 75 elderly patients who wore diapers all day in the hospital or nursing home. Patients were randomly assigned to receive treatment with either miconazole soap or miconazole-free placebo soap, and 28 patients in the miconazole group and 27 patients in the placebo group were followed for 4 weeks. Although washing with miconazole soap did not affect the frequency of pseudohyphae/blastoconidia-positive patients, it significantly inhibited the positive conversion of pseudohyphae/blastoconidia compared with the placebo group. As a result, the frequency of patients positive for pseudohyphae/blastoconidia was significantly lower in the miconazole group than in the control group at 4 weeks (17.9% vs 44.4%). Clinically apparent diaper candidiasis did not develop in either group. Washing with miconazole soap was a significant independent factor for reducing the cases positive for pseudohyphae/blastoconidia, while diarrhea and heart failure were significant factors associated with an increase in the positive rate at the end-point. Severe adverse effects were not found in any patients. Thus, washing with miconazole soap is well-tolerated and can inhibit the positive conversion of Candida in patients wearing diapers. Therefore, maintenance of genital hygiene using this soap may prophylactically decrease the overall prevalence of patients with diaper candidiasis.