The Experimental Study On Flutrimazole Cream In The Treatment Of Tinea Pedis

Tinea pedis is termed as a group of ringworm fungal infections that occur in toes, toe webs and digitorum pedis. It is one of the most common fungal dermatopathies. The incidence of tinea pedis is closely associated with season, age and occupation. Every type of the pathogen has strong endemicity that is largely decided by the diversity of areas. Common ringworm fungal strains can be divided into trichophyton rubrum, trichophyton baber, epidermophyton floccosum and trichophyton meginii, among which trichophyton rubrum is the most prominent cause of the disease. In the last few years, candida albicans and other yeast like microbes inducing tinea pedis were also reported.Due to many factors including the varieties of the pathogens, the hygiene habits and individual immune responses, the clinical expressions of the disease are not always the same. Hyperkeratotic pattern, papulosquamous pattern, bullae patern, interdigital erosional pattern, and tinea corporis pattern are five most common categories of tinea pedis. Treatment method varies in different cases. Clotrimazole,miconazole, ketoconazole, bifunazole, terbinafine and naftin are common external application drugs. Uriach, a well known Spanish pharmaceutical company designed and manufactured Flutrimazole, a new derivative of imidazole, which is served as topical medication especially for musty infections, such as tinea pedis, body tinea, facial tinea and tinea cruris caused by oidium porriginis, microsporum canis and epitermophiton floccosum. Candidal infections were also targeted by flutrimazole. Flutrimazole should be applied once a day. Comparing to clotrimazole, flutrimazole shows better antibiotic activities and wider spectrums. Furthermore, the anti-inflammatory activities and topical drug tolerance are good as well. Flutrimazole exerts great antifungal activities especially against superficial fungal infections. Smaller percutaneous absorption, relative longer half life time and detention period than other imidazole agents help keep high drug concentration as well as persistent antifungal capabilities.Object:Evaluate the clinical effects of 1% flutrimazole on the therapy of tinea pedis and collect corresponding safety data.Method: Random selected 120 cases from patients visiting dermatological department of second hospital of Jilin University during the period from June, 2009 to February, 2010. Double blind positive parallel test would be applied. The investigational medicine (flutrimazole) and the control medicine were respectively given to two randomly assigned groups that would be monitored closely during next four weeks and plus two weeks after drug withdraw. The statistics of clinical symptoms, signs, side effects and fungal examinations collected in every time point were analyzed by SPSS software to determine its clinical, antifungal and combined effects.Result: 120 cases of tinea pedis patients, aged from 18 to 60, diagnosed by clinical and fungal examinations were chosen. There were 73 men and 47 women among them. The pathogenesis period varied from one week to six years. 118 in all 120 patients were positive in fungal cultivation test. The positive rate reached 98.33 percent. The distribution of pathogen types in all cases was shown as follows: Trichophyton rubrum occupied mostly, 101 cases, as high as 85.5932%; 6 cases were trichophyton baber, 3.3898%; 4 cases were candida albicans, 3.3898%; 3 cases were trichophyton tonsurans, 2.5424%; 2 cases were epidermophyton floccosum, 1.6949%; 2 other cases were unknown types.The percentage of ones who had significant improvements of symptoms, full clearance of fungus, limited combined clinical responses, prominent combined clinical responses and complete recover in investigational group respectively reached 55.52, 63.33, 67.80, 27.12, 5.08 after two weeks since the medicine was applied. While the percentage of cases who had significant improvements of symptoms, clearance of fungus, limited combined clinical responses, prominent combined clinical responses and full recover in investigational group reached 93.83, 96.67, 3.39, 30.51, 66.10 respectively after four weeks since the medicine was applied.In the last step, the percentage of cases who had significant improvements of symptoms, clearance of fungus, prominent combined clinical effects and full recover in investigational group reached 96.55, 100, 18.64, 81.36 respectively after two weeks since the medicine was stopped being given to the patients. The negative rates of fungal microscopic examination, fungal cultivation test and fungal clearance between the investigational group and control group at the time points of week 2, week 4 and week 2 after medical withdraw have no statistical significance. As to the investigational group, the clinical effects of flutrimazole being applied for four weeks were better than those for two weeks. There was no statistical significance among clinical effects at the time points of week 2, week 4 and week 2 after medicine withdraw in both groups. During the whole procedure of double blind trial, one patient in the investigational group suffered slight side effects. No disorder was found in the biochemical tests in both groups before and after applying drugs.Conclusion: Flutrimazole belongs to high effective broad spectrum antifungal agent with dual effects of anti-fungus activities as well as anti-inflammation activities. The whole treatment process of tinea pedis using flutrimazole lasts nearly four weeks. Clinical effects were significant distinct in the different stages of the therapy. The negative rates of fungal microscopic examination, fungal cultivation test and fungal clearance in the investigational group and control group at each time point has no statistical significance. In the investigational group, the clinical effects of using flutrimazole for four weeks were proven to be better than those for only two weeks. There was no statistical significance among the clinical effects and response rates at each time point in two groups. Flutrimazole bears the same clinical and safety effects with bifonazole already on sale. In conclusion, flutrimazole cream is a safe and effective cutaneous using antifungal agent.