The objective of the present randomized, double-blind trial was to evaluate the efficacy and safety of daily topical washing procedure with miconazole nitrate-containing soap for candidiasis at diaper-covered sites in elderly subjects under long-term inpatient care. We initially enrolled 75 elderly patients with a constant use of diapers, and of this cohort, 55 patients (32 male and 23 female) who randomly assigned to receive treatment with either miconazole soap (n=28) or miconazole-free placebo soap (n=27) were assessed microscopically for the existence of the pseudohyphae and/or blastoconidia of Candida spp. up to 4 weeks. Although washing with miconazole soap did not affect the baseline frequency of pseudohyphae/blastoconidia-positive patients, it significantly inhibited the positive conversion of pseudohyphae/blastoconidia compared with the placebo group (17.3% vs. 44.0%, respectively; p<0.05). Moreover, the frequency of patients positive for pseudohyphae/blastoconidia at 4 week was significantly lower in the miconazole group than in the control group (17.9% vs. 44.4%, respectively; p<0.01). These anti-Candida effects were not different between both sexes, and neither clinically-apparent diaper candidiasis nor severe adverse effects developed in either group. Patients with diarrhea and heart failure tended to be associated with the positive rate of pseudohyphae/blastoconidia. A daily washing with miconazole soap is easy and quick to perform, as a paramedical stuff work, and well-tolerated for anogenital skin in elderly. This prophylactic approach can inhibit the progressive conversion activity of genital Candida flora, enabling to maintain satisfactory genital hygiene in patients wearing diapers.

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