Prolonged itraconazole treatment efficacious in patients with tinea corporis, tinea cruris

With prolonged treatment durations, itraconazole proved efficacious in the treatment of patients with tinea corporis or tinea cruris, although many patients relapsed after successful treatment, according to a study.

“Dermatophytosis is the most common fungal infection affecting humans and a considerable health care concern. ... This randomized clinical trial addressed the primary objective of comparing cure rates, treatment durations, safety profiles, and relapse with three dosages of itraconazole,” Ananta Khurana, MD, professor of dermatology at Dr Ram Manohar Lohia Hospital and Atal Bihari Vajpayee Institute of Medical Sciences, both in New Delhi, and colleagues wrote.

Eligible patients included adults with treatment-naïve tinea corporis or tinea cruris (TCC) involving at least 5% body surface area. The 149 enrolled patients were randomly assigned to daily itraconazole dosed at 100 mg, 200 mg or 400 mg. Each patient was blindly assessed at biweekly intervals until achieving a treatment cure (negative potassium hydroxide smears) or failure (< 50% improvement). At 8 weeks posttreatment, patients were evaluated again to detect relapse rates.

Of the 126 patients that completed the trial, 116 were cured, whereas seven patients in the 100 mg group and three in the 200 mg group failed treatments.

The cure rates were 82% in the 100 mg group, 93.2% in the 200 mg group and 100% in the 400 mg group, with an overall cure rate of 92.1%. The difference in cure rate was statistically significant between the 100 mg and 400 mg groups (HR = 2.87; 95% CI, 1.78-4.62) and between the 200 mg and 400 mg groups (HR = 1.99; 95% CI, 1.28-3.09); however, the difference between the 100 mg and 200 mg groups (HR = 1.44; 95% CI, 0.91-2.3) was not statistically significant.

The study found that treatment duration is positively correlated to the efficacy of the drug. Treatment duration ranged from 2 to 20 weeks to achieve a cure, with a mean duration of 6.63 weeks (standard deviation, 3.85 weeks). While the treatment duration was not statistically significant between the 100 mg and 200 mg groups, it was statistically significant between the 100 mg and 400 mg groups (7.7 weeks vs. 5.2 weeks; P = .03) and between the 200 mg and 400 mg groups (7.2 weeks vs. 5.2 weeks; P = .004).

According to the researchers, itraconazole showed effective and safe results in curing TCC; however, there was a 47.4% relapse rate. Of 116 patients that followed successful treatment completion, 59.4% in the 100 mg group, 41.5% in the 200 mg group and 44.2% in the 400 mg group relapsed.

“In this randomized clinical trial, we report high efficacy and safety of itraconazole at all studied doses and note that prolonged treatment durations are needed for achieving cure,” Khurana and colleagues wrote. “High relapse rates noted across all groups are disconcerting and call for more research focused on organism virulence factors.”