Two randomized, double-blind comparison studies were conducted to evaluate the efforts of 2 emollient dry skin creams containing urea in the management of dry skin in atopic patients. Cream with 10% urea was shown to be effective in the management of dry skin and hand dermatitis. The cream with a pH of 6 caused less burning.
A total of 725 patients with mycosis of the skin folds, large areas of the body or feet were entered into this double-blind, dose-finding study. Treatment with 0.125, 0.25 or 0.5% amorolfine cream was randomly allocated to patients. The cream was applied once daily for 4 weeks on average. At screening, in 527 patients evaluated for efficacy, a total of 533 pathogens were isolated: T. rubrum (322), T. mentagrophytes (84), E. floccosum (45), M. canis (42), other dermatophytes (14), C. albicans (24) and other yeasts (2). One week after the end of treatment, the culture was negative in 80.5, 81.3 and 84.8% of patients treated with 0.125, 0.25 or 0.5% amorolfine cream, respectively. The differences were not statistically significant. Forty-four out of 714 patients evaluated for safety had local adverse events: 14 (5.8%), 13 (5.5%) and 17 (7.1%) in the amorolfine cream 0.125, 0.25 and 0.5% groups, respectively. Due to local adverse events, six patients (2.5%) in the 0.125% group, six patients (2.6%) in the 0.25% group and seven patients (2.9%) in the 0.5% group discontinued the trial treatment. The most common adverse events were burning, itching, erythema and scaling. No systemic adverse events were reported.
This is the summary of a prospective, randomized, double-blind study comparing four therapeutic regimens: bifonazole cream applied once or twice daily, clotrimazole and placebo twice daily during 4 weeks for the treatment of cutaneous candidosis. The study is multicentric and was accomplished in four centres of different climate: Costa Rica, Dominican Republic, Sweden and Yugoslavia. The trial was carried out with approximately identical numbers of patients: 275 in total. The duration of treatment was 4 weeks and the check-ups were done before, during and 2 weeks after the end of the therapy. The results have shown the great efficacy of bifonazole cream (65–75%) in comparison to placebo (19.4%). There was no significant difference in applying bifonazole cream once or twice daily. So the reasonable therapy with bifonazole as to apply it only once a day, is confirmed. The excellent tolerance and absence of side-effects in such an extended study have once more proved the value of this antimycotic in topical treatment of cutaneous candidosis.
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