Article

Comparative study of the efficacy and safety of topical antifungal agents clotrimazole versus sertaconazole in the treatment of tinea corporis/cruris

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Abstract

Background: Tinea corporis is a common dermatophytic infection affecting 22-25% of the world population. Clotrimazole is conventional antifungal drug whereas sertaconazole is newer antifungal claimed to be superior to clotrimazole. Both are used topically. Aims and Objective: To compare the efficacy and safety of topical clotrimazole versus sertaconazole in tinea corporis/cruris. Materials and Methods: A total of 60 patients diagnosed with tinea corporis/cruris were randomized into two groups of 30 patients each. Group A received topical clotrimazole (1% cream), and Group B received topical sertaconazole (2% cream). The patients were advised to apply the drug on affected area twice daily for 4 weeks. Outcome parameters such as pruritus, erythema, vesicles and desquamation, and potassium hydroxide mount were noted weekly for the assessment of efficacy. Results: There was significant reduction in pruritus (P < 0.001), erythema (P < 0.001), vesicles (P < 0.001), and desquamation (P < 0.001) among both the groups. The mean difference and the standard deviation of the total score of all parameters (baseline to 4th week follow-up) for clotrimazole group were 6.39 ± 1.123 and for sertaconazole group were 7.37 ± 0.751, respectively. The P value on the application of students unpaired t-test was P = 0.115 (not significant). No serious adverse drug events in both the groups. Conclusion: Clotrimazole is as efficacious and safe as compared with sertaconazole in the treatment of tinea corporis/cruris. However, sertaconazole group has showed an early response to therapy compared to clotrimazole group.

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... 9 Topical Miconazole is widely used in the management of various types of skin infections caused by dermatophytes, yeasts, and Malassezia furfur. 11 Sertaconazole nitrate is a new antifungal azole agent that fights against yeasts,dermatophytesand Gram-positive bacteria as well. These recently developed antifungal agentsare characterized by broad spectrum action against yeasts, dermatophytes and Gram-positive bacteria as well. ...
Article
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Tineacorporis is a dermatophytic infection of the body, which involves the keratin layer of the skin. These lesions are present as an annular plaque with an advancing border along with central clearing. Miconazole, a topical antifungal drug and has good efficacy, in anti dermatophyte. Sertaconazole is a highly selective inhibitor of fungal cytochrome P-450 sterol C-14 α-demethylation via the inhibition of the enzyme cytochrome P450 14α-demethylase.It is claimed to be superior to other old topical imidazoles in tineacorporis. .The present study was aimed to compare the safety, efficacy and cost-effectiveness of topical antifungals, where we have compared Miconazole and Sertaconazole 2% creams in the treatment of fungal infection caused by tineacorporis, by assessing the ADR’s and therapeutic outcomes, using comparative, unicentered, randomized, non-blinded trial with 2 parallel treatment arms of one-month duration. In this study 106 patients were randomly assigned into 2 groups of Miconazole 2% cream and Sertaconazole 2% with 54 and 52 patients in each group respectively. Measurement is carried out at baseline, 1st, 2nd and 3rd follow-up for desired effects like itching, erythema, pain and lesions, physician’s global assessment (PGA), safety and cost-effectiveness. The results showed that sertaconazole 2% cream is efficacious and superior to Miconazole 2% cream in the improvement of clinical parameters and PGA. At the end of the follow-up phase, both groups of drugs are effective and well-tolerated in patients with no recurrence of tineacorporis. Effectiveness of Sertaconazole is early and superior with minor side effects. However, Miconazole is cost effective and safe.
... 9 Topical Miconazole is widely used in the management of various types of skin infections caused by dermatophytes, yeasts, and Malassezia furfur. 11 Sertaconazole nitrate is a new antifungal azole agent that fights against yeasts,dermatophytesand Gram-positive bacteria as well. These recently developed antifungal agentsare characterized by broad spectrum action against yeasts, dermatophytes and Gram-positive bacteria as well. ...
Article
Full-text available
Tineacorporis is a dermatophytic infection of the body, which involves the keratin layer of the skin. These lesions are present as an annular plaque with an advancing border along with central clearing. Miconazole, a topical antifungal drug and has good efficacy, in anti dermatophyte. Sertaconazole is a highly selective inhibitor of fungal cytochrome P-450 sterol C-14 α-demethylation via the inhibition of the enzyme cytochrome P450 14α-demethylase.It is claimed to be superior to other old topical imidazoles in tineacorporis. .The present study was aimed to compare the safety, efficacy and cost-effectiveness of topical antifungals, where we have compared Miconazole and Sertaconazole 2% creams in the treatment of fungal infection caused by tineacorporis, by assessing the ADR's and therapeutic outcomes, using comparative, unicentered, randomized, non-blinded trial with 2 parallel treatment arms of one-month duration. In this study 106 patients were randomly assigned into 2 groups of Miconazole 2% cream and Sertaconazole 2% with 54 and 52 patients in each group respectively. Measurement is carried out at baseline, 1 st , 2 nd and 3 rd follow-up for desired effects like itching, erythema, pain and lesions, physician's global assessment (PGA), safety and cost-effectiveness. The results showed that sertaconazole 2% cream is efficacious and superior to Miconazole 2% cream in the improvement of clinical parameters and PGA. At the end of the follow-up phase, both groups of drugs are effective and well-tolerated in patients with no recurrence of tineacorporis. Effectiveness of SSertaconazole is early and superior with minor side effects. However, Miconazole is cost-effective and safe.
... [17,18] Both the group of drugs was found to be safe and well tolerated by the patients. The safety has been quoted by the Prabha [9] and Satish et al. [19] On doing cost-effective analysis, treatment modality having low cost-effective ratio (CER) is considered to be superior to the other drug. [20] It was observed in our study CER was high for clotrimazole drug than luliconazole at the end of two weeks as the cure rate was more in luliconazole group. ...
Article
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Background: Dermatophytosis is a superficial fungal infection that has high affinity for keratinized tissues of the body. The treatment of localized dermatophytosis is a major concern for the dermatologist especially in tropical countries like India. Various topical antifungals are available for the treatment of localized uncomplicated dermatophytosis. Luliconazole is an azole antifungal available that has potent activity against dermatophytes. Objectives: The objective of this study was to compare two treatment modalities for the treatment of localized dermatophytosis in terms of efficacy, safety, and cost evaluation. Materials and methods: This was a prospective and observational study carried out for 6 months and included 200 patients (luliconazole group [n = 94] and clotrimazole group [n = 106]). Patients were followed up for 2, 4, and 6 weeks. Outcome parameters such as pruritis, erythema, scaling, vesiculations, and global assessment score were noted at 2, 4, and 6 weeks for the assessment of efficacy. The statistical analysis was done using Chi-square and Student's t-test. Results: Luliconazole and clotrimazole showed 56.38% and 23.58% cure rate at the end of two weeks respectively (P < 0.05). At the end of treatment, the cure rates were 98.93% and 95.28% in luliconazole and clotrimazole, respectively (P > 0.005). Both the drugs were equally safe. On cost-effective analysis, luliconazole was found to be more cost-effective than clotrimazole at the end of 2 weeks. Conclusion: Therapeutic efficacy of luliconazole was more as significant proportion of patients achieved complete clearance of lesions at faster rate within 2 weeks with convenient once daily application.
... Moreover, as per the studies conducted by Khan et al, Shivamurthy et al, and Satish et al; topical sertaconazole has shown better therapeutic response in comparison with topical clotrimazole in other types of tinea infections such as tinea corporis. [9][10][11] In this manner, the study results of this study is quite similar to the previously conducted studies on comparison of topical antifungals in other tinea infections. ...
Article
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p class="abstract"> Background: Tinea cruris is a common superficial dermatophytic infection of the skin occurring in 20-25% population worldwide. The various types of antifungal agents are available for topical use in treatment of tinea cruris. Clotrimazole is conventional imidazole antifungal drug whereas sertaconazole is newer imidazole antifungal claimed to be superior to clotrimazole in tinea infection. The aim of the study was to determine and compare the efficacy of potent topical azole agents 1% clotrimazole and 2% sertaconazole in patients diagnosed with tinea cruris attending out-patient department of skin and VD of tertiary care hospital in Vadodara. Methods: A total of 71 patients diagnosed with tinea cruris were divided into two groups. Group A received topical clotrimazole (1% cream), and Group B received topical sertaconazole (2% cream). Outcome parameters such as erythema, scaling, itching, margins of lesions and size of lesions were noted atthe time of hospital visit, by 3rd week and by 6th week for the assessment of efficacy. The statistical test used was independent student t-test and software used was SPSS 20.0. Results: At the end of follow-up phase, both the drugs were found to be effective with no recurrence or relapse of tinea cruris. However, compared to clotrimazole 1% cream, sertaconazole 2% cream had statistically significant rapid relief in terms of reduction in clinical parameters such as erythema (p<0.001), scaling (p<0.001), itching (p<0.001), size of lesion (p<0.001) and margin of lesion (p<0.011). Conclusions: Topical sertaconazole 2% cream was found to be highly efficacious and superior to clotrimazole 1% cream in improvement of clinical parameters of tinea cruris.</p
Article
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Article
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Book
The late Arthur Rook established the Textbook of Dermatology as the most comprehensive work of reference available to the dermatologist. Covering all aspects of skin disease from basic science through pathology and epidemiology to clinical practice, the text is recognized for its unparalleled coverage of diagnosis. Hailed by reviewers as 'a thorough, modern masterpiece' and 'the best textbook of dermatology in the world', and trusted by dermatologists around the world for accurate and comprehensive coverage, this clinical classic is the definitive source of information for all dermatologists. The new edition of this venerable classic extends the standard of excellence to include: All-new coverage of cosmetic dermatology and sexually transmitted diseases. More material on evidence-based dermatology. Increased coverage of dermoscopy. More emphasis on therapeutics throughout the set. More contributions from a greater variety of international experts. New page design with larger illustrations for more immediate recognition. The 8th Edition marks the debut of the online edition of Rook's Textbook of Dermatology, allowing users the fastest possible access to the full range of knowledge on all known dermatological conditions. With fully searchable text and a fully searchable bank of more than 3,300 downloadable images, this online version puts specific information at your fingertips - when and where you need it - and is free with purchase of the four-volume set. The person-specific access code travels with you, not your computer, so you can check with Rook from any location. With the online version, you can: Search across all four volumes simultaneously. Search all images separately. Download images into presentations. Link directly to references via a range of sources. Rook's Textbook of Dermatology, in print and now online, provides a reliable, constant companion for all dermatologists.
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The incidence of fungal infections is increasing at an alarming rate, presenting an enormous challenge to healthcare professionals. This increase is directly related to the growing population of immunocompromised individuals especially children resulting from changes in medical practice such as the use of intensive chemotherapy and immunosuppressive drugs. Although healthy children have strong natural immunity against fungal infections, then also fungal infection among children are increasing very fast. Virtually not all fungi are pathogenic and their infection is opportunistic. Fungi can occur in the form of yeast, mould, and dimorph. In children fungi can cause superficial infection, i.e., on skin, nails, and hair like oral thrush, candida diaper rash, tinea infections, etc., are various types of superficial fungal infections, subcutaneous fungal infection in tissues under the skin and lastly it causes systemic infection in deeper tissues. Most superficial and subcutaneous fungal infections are easily diagnosed and readily amenable to treatment. Opportunistic fungal infections are those that cause diseases exclusively in immunocompromised individuals, e.g., aspergillosis, zygomycosis, etc. Systemic infections can be life-threatening and are associated with high morbidity and mortality. Because diagnosis is difficult and the causative agent is often confirmed only at autopsy, the exact incidence of systemic infections is difficult to determine. The most frequently encountered pathogens are Candida albicans and Aspergillus spp. But other fungi such as non-albicans Candida spp. are increasingly important.
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Sertaconazole is a new antifungal agent. To compare the efficacy and tolerability of sertaconazole and miconazole cream in cutaneous dermatophytosis, this prospective, randomized, multicentric comparative, phase 4 study was undertaken in 260 patients with cutaneous dermatophytosis after approvals from Institutional Ethics Committees. Patients were assigned to sertaconazole cream (2%) or miconazole cream (2%) topically twice daily for 2 weeks after obtaining informed consent. Efficacy variables included changes in mean scores of erythema, pruritus, desquamation, erythema/itching, burning/weeping, scaling/pustule and overall global assessment. Safety and tolerability were also assessed. A total of 122 patients in the sertaconazole group and 128 in the miconazole group completed the study with 10 drop-outs. There was a significant decrease (P < 0.05) in mean symptom scores and total scores from the first week onwards, sustained till 2 weeks and statistically significant (P < 0.05) in favour of sertaconazole. Moreover, 62.3% patients had complete clinical cure in the sertaconazole group (P < 0.05) compared with 44.6% in miconazole users. Both drugs were well tolerated and five patients in the sertaconazole group and nine in the miconazole group reported mild to moderate adverse events. Therapy with sertaconazole cream (2%) provided a better efficacy and tolerability compared with the miconazole cream (2%) and could thus be a therapeutic option in cutaneous dermatophytosis.
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Sertaconazole (Dermofix (R), Ertaczo (TM), Ginedermofix (R), Monazol, Mykosert (R) or Zalain (R)), an imidazole antifungal agent, inhibits the synthesis of ergosterol, an essential cell wall component of fungi. It is indicated in the EU for the treatment of superficial skin mycoses such as dermatophytosis (including tinea corporis, tinea cruris, tinea manus, tinea barbae and tinea pedis), cutaneous candidiasis, pityriasis versicolor and seborrhoeic dermatitis of the scalp, and in the US for tinea pedis only. Sertaconazole has broad-spectrum antifungal activity against dermatophytes of the Trichophyton, Epidermophyton and Microsporum genera, and yeasts of the genera Candida and Cryptococcus; additionally, it is effective against opportunistic filamentous fungi and Gram-positive bacteria. Moreover, the antifungal activity of sertaconazole is maintained in clinical isolates of dermatophytes that show reduced susceptibility to other azoles. While the drug has good dermal penetration, this is not associated with systemic absorption. In clinical trials in patients with superficial mycoses, 2% sertaconazole cream applied twice daily was effective in the eradication of a range of dermatophytoses, and a significantly greater proportion of patients were cured compared with those receiving 2% miconazole cream twice-daily treatment. In patients with vulvovaginal candidiasis, sertaconazole as a single-dose ovule or tablet was effective in the eradication of Candida spp., and achieved both a more rapid and a higher cure rate compared with a triple dose of econazole. Both as a topical cream and suppository preparation, sertaconazole was generally well tolerated. Sertaconazole is a well established antifungal agent, which is now available in a variety of formulations, and remains a useful treatment option particularly in patients with fungal infections resistant to other azoles.
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The activity of 7-chloro-3-[1-(2,4-dichlorophenyl)-2-(1H-imidazol-1-yl) ethoxy-methyl]benzo[b]thiophene (sertaconazole, FI 7045, CAS 99592-32-2), a new topical antifungal, was studied in vitro against several infecting organisms. The results obtained show that sertaconazole is a broad-spectrum antifungal against yeasts (C. albicans, C. tropicalis, C. pseudotropicalis, C. krusei, Trichosporon and Cryptococcus), dermatophytes (Microsporum, Trichophyton and Epidermophyton), opportunistic filamentous fungi (Aspergillus) and Gram-positive bacteria. The MIC (minimum inhibitory concentration) values for the fungistatic activity were between 0.35 and 5.04 micrograms/ml for yeasts and between 0.24 and 2 micrograms/ml for dermatophytes; even partial activities (IC25) against these organisms were obtained at concentrations 10 times lower than those mentioned. At concentrations superior to MIC (MFC between 0.5 and 16 micrograms/ml), sertaconazole exhibited fungicidal activity.
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The in vitro activity of sertaconazole was compared with those of the most commonly used vaginal antimycotic agents--fluconazole, ketoconazole, fenticonazole, clotrimazole and itraconazole--against 94 strains of clinical isolates of Candida spp. using a macrodilution method in Casitone agar medium. The sertaconazole concentration (microgram/ml), at which 90% of the strains were inhibited, was 0.06 for C. albicans, 0.25 for C. glabrata and C. parapsilosis, 1 for C. krusei and 2 for C. tropicalis. These values show that sertaconazole is one of the most active products against yeasts causing vulvovaginal candidiasis, its activity against C. glabrata being particularly relevant.
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The use of antifungal/corticosteroid combinations as topical therapy for dermatophytoses has been criticized as being less effective, more expensive, and the cause of more adverse cutaneous reactions than antifungal monotherapy. The combination of clotrimazole and betamethasone diproprionate (Lotrisone) is a mix of an azole antifungal and a high-potency corticosteroid, and is one of the most widely prescribed of these combinations. Our objective was to describe the beneficial and deleterious effects of Lotrisone in the treatment of common cutaneous fungal infections and its relative cost-effectiveness. We did a literature review documenting clinical trial data and adverse reactions to Lotrisone and collected a cost analysis of topical antifungal prescribing data over a 2-month period from a large midwestern staff-model health maintenance organization (HMO). Lotrisone is approved by the U.S. Food and Drug Administration (FDA) for the treatment of tinea pedis, tinea cruris, and tinea corporis in adults and children more than 12 years of age. Treatment is limited to 2 weeks in the groin area and 4 weeks on the feet. The most concerning adverse effects of Lotrisone were reported in children and included treatment failure, striae distensae, hirsuitism, and growth retardation. This combination was also reported to have decreased efficacy in clearing candidal and Trichophyton infections as compared to single-agent antifungals. Lotrisone was considerably more expensive than clotrimazole alone and was found to account for more than 50% of topical antifungal expenditures as prescribed by primary care physicians, but only 7% of topical antifungals prescribed by dermatologists. We found that Lotrisone was shown to have the potential to induce many steroid-related side effects and to be less cost effective than antifungal monotherapy. This combination should be used judiciously in the treatment of cutaneous fungal infections and may not be appropriate for use in children.
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The evaluation of susceptibility patterns of clinical and laboratory isolates of dermatophytes and Candida to sertaconazole nitrate has been determined using macrodilution and microdilution test methods in laboratories worldwide. Antimycotics that have been compared to sertaconazole nitrate include itraconazole, clotrimazole, miconazole, and terbinafine. A comparison of the minimum inhibitory concentrations clearly shows differences in potency and spectrum among the various agents. This article reviews the antifungal activity of sertaconazole nitrate against major fungal pathogens that cause and complicate tinea pedis. In light of the new topical formulation of sertaconazole nitrate, this compilation of data from the literature is helpful for relating in vitro data to the tissue concentrations required for effective eradication of cutaneous fungal infections.
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This is an attempt to find the species prevalence of various dermatophytes in patients with dermatophytosis in our hospital in Baroda. Two hundred and sixty clinically suspected cases of dermatophytosis were subjected to mycological studies. One hundred and fifty seven cases (60.38%) were positive for fungus in direct microscopy while 116 (44.62%) were culture positive. Tinea corporis was the most common clinical presentation followed by tinea cruris. Young adults in the age group of 16-30 yrs were mainly affected. The male to female ratio was 1.57:1. Trichophyton rubrum (73.27%) was the most common isolate, followed by Trichophyton mentagrophytes (17.24%), Epidermophyton floccosum (7.75%) and Trichophyton violaceum (1.72%). Trichophyton rubrum was the predominant fungus found in this area of Gujarat, followed by Trichophyton mentagrophytes, Epidermophyton floccosum and Trichophyton violaceum.
Comparison of safety and efficacy of luliconazole and other antifungal agents
  • T Chandana
  • C H Saritha
  • P Shankaraiah
Chandana T, Saritha CH, Shankaraiah P. Comparison of safety and efficacy of luliconazole and other antifungal agents. Int J Pharm Sci Res. 2014;5(1):1-9.
Goodmann and Gillman's the Pharmacological Basis of Theraupetics. 12 th ed
  • J E Bennett
  • L L Brunton
  • B C Knollmann
  • B A Chabner
Bennett JE. Antifungal agents. In: Brunton LL, Knollmann BC, Chabner BA, editors. Goodmann and Gillman's the Pharmacological Basis of Theraupetics. 12 th ed. New York: McGraw Hill; 2014. p. 1571-91.