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Double-blind comparison of amorolfine and bifonazole in the treatment of dermatomycoses.

A total of 232 patients with mycoses of skin folds, body, or feet were entered into a double-blind, parallel group-study. Therapy with 0.125, 0.25, 0.5% amorolfine cream or 1% bifonazole cream was randomly allocated to patients. The cream was applied once daily for 4 weeks on average. At screening, in 208 patients evaluated for efficacy, a total of 225 fungi were isolated: T. rubrum (77), T. mentagrophytes (65), other dermatophytes (15), C. albicans (34), other yeasts (26) and moulds (8). One to three weeks after ending therapy, the percentage of patients with negative cultures were as follows: 87.3, 91.7, 90.7 and 92.2% in the amorolfine cream 0.125%, 0.25%, 0.5% and bifonazole cream 1% groups respectively. The differences were not statistically significant. Six out of 223 patients evaluated for safety had local adverse events: one (1.7%), two (3.6%) and three (5.4%) in the amorolfine cream 0.125%, 0.25% and bifonazole cream 1% groups respectively. The most common local adverse events were burning and increased itching, erythema or weeping. A once-daily application of amorolfine cream can be recommended for the treatment of dermatomycoses on the basis of the results from this study. However, a further and similar study with a larger number of patients was required to select the concentration of amorolfine cream for therapeutic use.

Antifungal Agents

Dermatomycoses among industrial workers in Cross River State, Nigeria.

A survey of dermatomycoses was carried out amongst industrial workers in three different factories during the period 1987-1988. A total of 194 workers were screened, out of which 54 proved to be mycologically positive by microscopy and/or culture. Incidence was apparently highest amongst workers in a cement factory (Calcemco, 33.3%) followed by those in a wood factory (Seromwood, 30.8%) and a rubber factory (CREL, 26.2%). Pityriasis versicolor was the predominant clinical type of dermatomycosis, followed by tinea pedis. A total of 51 fungal organisms were identified. Malassezia furfur was the most prevalent causative agent (74.4%) followed by Trichophyton soudanense (5.8%), T. rubrum (3.9%) and Epidermophyton floccosum (3.9%). Other species identified were one isolate each of T. tonsurans, T. mentagrophytes, T. verrucosum, Candida tropicalis, Candida spec. and Geotrichum candidum.

Adult

Topically applied griseofulvin in the treatment of superficial dermatomycoses in Egypt.

One-hundred and fifty-five patients suffering from T. Capitis, T. Corporis, T. Cruris and T. Verisicolor participated in studies of topically applied griseofulvin. Various concentrations of the drug were prepared in an ointment form in a new solvent system. Successful results were obtained with the 2% preparation in cases of T. Corporis, T. Cruris and T. Versicolor. Failure of the therapy was observed in cases of T. Capitis. No side-effects occurred in any patient using the 2% preparation. In the opinion of the authors, topically applied griseofulvin in the new solvent system is safe and highly effective in the treatment of superficial dermatomycoses.

Administration, Topical

[Dermatomycoses in workers in enterprises of the microbiological industry].

Mycologic examination of 54 patients with clinical manifestations of dermatomycosis, engaged in glucose oxidase and catalase production has found a producer fungus, Penicillium vitale in 31 (38%); 3 out of 37 people contacting with producers of glucamylase and pectofetidine appeared to be infected by Aspergillus awamori (1.1%) and Aspergillus foetidus (1.1%), respectively. The producers were isolated from the skin of 40 (16.44%) out of 243 workers having no clinical signs of dermatomycosis, mainly in drying, granulating and microbiology lab workers. Dermatophytes (50.9%), yeast fungi (1.8%) and other agents were isolated from the skin of patients with clinical manifestations of dermatomycoses. Age and sex of personnel, length of service and infectious contamination of technological premises were found to influence the skin disorder caused by dermatophytes in combination with producer fungi. Prophylactic measures to prevent the contamination of air and skin by producer fungi and their metabolite are to be developed.

Adult

Treatment of dermatomycoses and onychomycoses--state of the art.

We have reached a stage whereby many of the superficial mycoses are treatable with short courses of antifungal drugs. However, the minimum duration of therapy has still not been well defined and there remain some mycoses which do not respond to conventional therapy. It may be possible to introduce more radical approaches to therapy such as the single-dose oral or topical therapy for tinea pedis or short-duration therapy for onychomycosis. Amongst these options, topical therapies still have a part to play in the management of onychomycosis, and the role of amorolfine in this respect is of potential value. The ability of the drug to produce lasting remissions after short courses of treatment is also of great interest. Last, but not least, amorolfine has an in-vitro spectrum of activity which covers some of the less common cutaneous pathogens, and hence it may prove of benefit in those infections for which treatment at present is limited.

Antifungal Agents

Dose-finding study of amorolfine cream (0.125%, 0.25% and 0.5%) in the treatment of dermatomycoses.

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.

Administration, Topical

Experience with amorolfine in the treatment of dermatomycoses.

In a double-blind randomized comparative study, 75 patients were treated with amorolfine cream 0.125, 0.25 or 0.5%. At the end of treatment clinical cure rates of 80, 76 and 84%, respectively, and mycological cures of 72, 64 and 76% were obtained. At 2 months posttherapy follow-up relapse rates were 0, 12 and 12%, respectively. There was no significant difference between the three groups in terms of clinical and mycological response, duration of treatment or tolerance. In a double-blind parallel study, 40 patients were treated topically with either 0.5% amorolfine cream or 1% bifonazole cream. The percentages of combined clinical and mycological cures were 83.3 and 78.95%, respectively. There was no significant difference in terms of tolerance and clinical and mycological cure rates. All treatments were applied once daily. Posttreatment MIC values did not indicate development of resistance to either amorolfine or bifonazole.

Administration, Topical

Miconazole nitrate in the treatment of dermatomycoses.

Miconazole nitrate was used topically in 83 dermatophytic and candidal infections. Complete cure was obtained in 81% of the cases. The in vitro studies made before, during and after treatment showed no evidence of resistance to the drug. The miconazole 2% cream and powder preparations were well tolerated. Only one case of sensitization was observed.

Administration, Topical