Efficacy of terbinafine and itraconazole in different doses and in combination in the treatment of tinea infection: A randomized controlled parallel group open labeled trial with clinico-mycological correlation

Abstract

Background: There is a rising prevalence of dermatophyte infection especially in the tropics. It has been observed that the antifungals are not as effective as they used to be. Aims: To determine the effectiveness of terbinafine and itraconazole in different doses and in combination in the treatment of tinea infection. Materials and Methods: Study design was a randomized parallel group trial. Patients were randomly divided into five parallel arms in which two of the standard drugs in recommended doses were compared with their double doses and with combination of both the drugs. Patients were followed up every 2 weeks. Outcomes were assessed at 4 and 8 weeks. Cure was considered as complete clinical resolution of the lesions. Fungal culture and sensitivity were done by disk diffusion method for all patients. Parametric one-way analysis of variance ( F test) and Chi-square test were used for the analysis. Results: Two-hundred seventy-five patients were included in the study. Itraconazole containing groups showed significantly higher cure rates than terbinafine only groups both at 4 and 8 weeks ( P < 0.001). Itraconazole containing groups, when compared against each other, were not found to be significantly different. The outcomes between terbinafine only groups were also not significantly different. Cure rates at 8 weeks were found to be greater than that at 4 weeks for all groups which were found to be highly significant ( P < 0.001). Conclusions: Itraconazole seems to be more effective than terbinafine. There is no benefit in increasing the dose or using a combination regimen in the treatment of tinea. Prolonged duration of treatment is required for complete cure.

Efficacy and safety of 250 mg versus 500 mg oral terbinafine in the treatment of tinea corporis and cruris: A randomised, assessor-blinded comparative study

“…Among the 60 participants enrolled in our study, females marginally outnumbered males, though earlier studies reported a predominance of males. 4 In a recent report Verma et al have postulated that changing fashion trends in women like body-hugging jeans, jeggings and leggings lead to more sweating and occlusion. 5 The most common clinical variant was combined tinea corporis and cruris (81.7%) which is in accordance with previous reports by Babu et al and Singh et al 3,4 Fungal growth on culture in our study was seen in 86.7% of patients; previous studies have reported yields of 73.68% (Singh et al), 6 76.38% (Bindu et al), 7 and 85.9% (Poluri et al).…”

“…This is similar to the findings by Singh et al who reported a cure rate of 33% with terbinafine 500 mg daily. 4 However Bhatia et al have reported a cure rate of 74%. 9 In a retrospective study by Babu et al, 80% of patients showed more than 75% improvement with terbinafine 500 mg daily.…”

“…2 Of late, dermatologists have been upscaling the dose of oral terbinafine to 500 mg daily either as a single daily dose or in divided doses. There are quite a few studies which have explored and reported 500mg of oral terbinafine to be effective in the treatment of tinea, but this effectiveness has not been compared with that of 250 mg. 3,4 Moreover, doubling the dose increases the financial burden on patients and may also increase the likelihood of adverse effects.…”

Oral Isotretinoin Combined with Oral Terbinafine Versus Oral Terbinafine Alone to Treat Recurrent Dermatophytosis

“…[ 8 9 ] Several strategies have been tried to increase the cure rates, including hiking up the dose of antifungal drugs, increasing treatment duration,[ 10 ] using a combination of more than one oral antifungal agent, and penetration enhancers. [ 11 ] There was a report of successful use of a combination of oral isotretinoin (20 mg/day) and oral itraconazole (200 mg/day) in the treatment of recurrent and recalcitrant dermatophytosis. [ 6 ] Isotretinoin increases the proliferation rate of the epidermis increasing the shedding of keratinocytes, which was hypothesized to help in eliminating the organisms.…”

“…Culture positive rates have varied from 40.3% to 87.4% in previous studies. [ 11 22 ] According to some recent studies T. mentagrophytes or interdigitale is more commonly isolated than T. rubrum , indicating a shift in the etiological agent. [ 23 ] However, another study from North India reported T. rubrum as the most common isolate (46.4%).…”