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Comparative Evaluation of Efficacy and Safety of Topical Fluconazole

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Comparative Evaluation of Efficacy and Safety of Topical Fluconazole Journal of Pakistan Association of Dermatologists 2012; 22 (4):342-349. Original Article Comparative evaluation of efficacy and safety of topical fluconazole and clotrimazole in the treatment of tinea corporis Manasi Banerjee*, Asim Kumar Ghosh*, Sukumar Basak**, Kapil Dev Das¶, Dwijendra Nath Gangopadhyay¶ *Department of Pharmacology, Medical College, Kolkata, India ** Department of Mycology, School of Tropical Medicine, Kolkata, India ¶Department of Dermatology, Venereology & Leprosy, School of Tropical Medicine, Kolkata, India Abstract Objective To assess the clinical efficacy and safety of fluconazole 0.5% gel in patients with mild to moderate grades of tinea corporis in comparison to clotrimazole 1% cream. Patients and methods Patients presenting with symptoms of tinea corporis were mycologically confirmed for presence of fungal hyphae and were randomly divided into two groups, one group received fluconazole and the other received clotrimazole. Treatment duration was for 4 weeks and study duration was for 8 weeks. Clinical evaluation was carried out on day 1, day 14, day 28 and a follow-up on day 56. Adverse effects were also recorded. Data entry was done in Excel data sheet and analyzed with Epiinfo 2002. Chi-square test and t test were carried out according to the type of data. Results Both the groups were matched at baseline in respect to their demographic profile. Significant improvement in efficacy parameters was seen in both the groups suggesting that both the drugs are effective against tinea corporis infection. Between groups comparison of mycological cure rate and clinical improvement showed no significant difference. The safety and tolerability profile of both regimens were good and statistically comparable. Conclusion Fluconazole 0.5% gel is found to be safe, effective and tolerable for mild to moderate tinea corporis. Its clinical effectiveness is comparable to that of clotrimazole, when used topically in tinea corporis. Keywords Fluconazole, clotrimazole, tinea corporis, topical antifungal agents. Introduction capable of causing skin changes of the type known as ringworm or dermatophytosis. The Tinea corporis is a very common form of ringworm species are all moulds belonging to superficial dermatophytosis infection of the skin three asexual genera: Microsporum , in patients seeking treatment at our hospital, a Trichophyton and Epidermophyton . tertiary care center. Dermatophytes are fungi Address for correspondence With increasing number of people travelling Dr. Manasi Banerjee worldwide, mycoses that were previously Associate Professor, restricted to certain geographic areas can now be Department of Pharmacology Medical College, Kolkata, India seen in other areas as well. In recent years, the Mobile No: 09051740432 number of fungi recognized as human pathogens Email: [email protected] 342 Journal of Pakistan Association of Dermatologists 2012; 22 (4):342-349. has risen, partly in debilitated and topical delivery of fluconazole, has shown immunocompromised patients.1 A survey beneficial results in terms of easy preparation, conducted by World Health Organization on the safety, stability and low cost.7 Results of another prevalence of dermatophytic infection has in-vitro study using different formulations of shown that 20% of people presenting for clinical fluconazole in microemulsion base has indicated advice are suffering from cutaneous fungal that the microemulsion system would be a infections worldwide. 2 promising tool for enhancing the percutaneous delivery of fluconazole.8 A topical formulation Tinea corporis refers to tinea infection anywhere of fluconazole as 0.5% gel is available in the on the body except the scalp, beard, feet, or Indian market for use in tinea corporis. This hands. This lesion presents as an annular plaque study aims to assess the efficacy and safety of with a slightly raised and often scaly, advancing fluconazole 0.5% gel as compared to border and is commonly known as ringworm. clotrimazole 1% cream as antifungal agent in Each lesion may have one or several concentric dermatophytic infection. rings with red papules or plaques in the center. As the lesion progresses, the center may clear, Patients and methods leaving post-inflammatory hypopigmentation or hyperpigmentation. Patient screening and recruitment were carried out at the Dermatology outdoor clinic of School Both topical and systemic therapies may be used of Tropical Medicine, Kolkata which is a tertiary to treat dermatophyte infections. Topical therapy care hospital. One hundred and fifty patients of is generally effective for uncomplicated tinea either sex in the age group 18-65 years with a corporis of small areas and of short duration. 3 clinical diagnosis of mild to moderate grades of An ideal topical agent for superficial fungal tinea corporis were selected for the study. infections should have broad-spectrum activity, Patients were evaluated following the pre- high mycological cure rate, convenient dosing, determined inclusion and exclusion criteria. low incidence of side effects and low cost. The Written informed consent was mandatory for imidazole antifungal agent clotrimazole has been participation in the study. Necessary ethical widely used topically for the treatment of clearance was obtained from the institutional superficial dermatophytosis for a long time.4,5 ethical committee. Although there is no report of resistance to this drug in dermatophytosis, alternatives are in Patients with uncontrolled diabetes, HIV search in anticipation. infection or suffering from concomitant bacterial infection were excluded from the study. Fluconazole, a fluorinated bis triazole compound Pregnant or lactating mothers and female is in use as an oral antifungal agent for a long patients of the reproductive age group practicing time. It is used in candidiasis, cryptococcosis, unreliable methods of contraception were dermatophytoses and other mycoses.6 So far excluded from the study. Those who received very little data are available on the efficacy of systemic and/or topical antifungal agents during topical fluconazole on mycoses of keratinized the last one month were also excluded. Patients tissue, and experience with this therapy is with negative skin scraping for fungus from a limited. A microemulsion based lecithin clinically suspected lesion on baseline visit were organogel formulation of fluconazole studied for also excluded from the study. 343 Journal of Pakistan Association of Dermatologists 2012; 22 (4):342-349. Study design This is a randomized, controlled Assessment of efficacy and safety During the trial with three parallel treatment arms. The 150 first visit, the patient was screened which also patients selected for the study were divided into served as the baseline visit if he/she was not three groups randomly. Each group was receiving any interacting drug. A separate allocated one topical antifungal, namely, baseline visit was advised for those taking any clotrimazole, fluconazole or amorolfine. The interacting drug, after appropriate wash-out results of the comparative study regarding period on withdrawal of the drug. At screening a efficacy and safety of topical clotrimazole and thorough medical history was taken and clinical amorolfine have already been published.9 In the examination of the potential subjects was done present study, we report the results of the to assess their suitability for participation in the efficacy and safety of topical fluconazole in study. Informed consent was obtained. Skin comparison to that of topical clotrimazole. scrapings were collected, treated with 10% KOH and examined under microscope for Each patient visited the investigator four times determination of fungal elements. In patients during the trial. After the baseline visit, they with history indicating diabetes or co-existing were asked to report again on day 14, day 28 and disease, routine blood examinations were taken on day 56 for follow-up to look for any relapse. up. The study medication was dispensed to the The study was designed as single-blind, as the subject following randomization, provided all dermatologist who recruited and evaluated the inclusion and exclusion criteria were satisfied. patients was kept blinded regarding the The patients were instructed to apply the cream treatment allocation. thinly to the affected area twice daily. All patients were asked to maintain a trial diary. Study drugs Fluconazole 0.5% gel and clotrimazole 1% were dispensed to the patients On the second visit at day 14, the patient was according to randomization. The patients were clinically examined and compliance determined instructed to apply the medications twice daily from the trial diary. Adverse events if any were for four weeks. The first application was recorded. Mycological examination was supervised. Thereafter, the patient was advised repeated. A second dose of study medication to use the medication as per the study schedule. was dispensed if necessary. Accountability was assessed by evaluating the trial diary asked to be maintained by the patient. During the third visit on day 28, clinical assessment was repeated, compliance Patients enrolled for the study were not determined, adverse events if any recorded and permitted to concomitantly use any antifungal mycological examination was also done. The other than the trial drug. Any other medication patients were instructed to discontinue known to interact with or potentially alter the application of the medicine. response to the study drugs was not permitted. Systemic
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