Recurrence of dermatophytosis and therapeutic efficacy of systemic antifungals in recurrent dermatophytosis of adults– A randomized, assessor-blind controlled trial in a tertiary institution

Use of systemic antifungals in recurrent dermatophytosis: A randomized, controlled trial.

Abstract

Background- Dermatophytosis is becoming difficult to treat in India by traditional treatment regime for its frequent relapse or recurrence. Objective- To validate the efficacy and safety of supra-pharmacological dose of Itraconazole in one arm and combination of Itraconazole and Terbinafine in another arm for successful treatment of recurrent dermatophytosis. Methods- The study was a single-center, randomized, assessor-blind, parallel-group, multi-arm, controlled trial on 155 patients with allocation ratio as 1:1:1. The control group (Group A) received conventional dose of oral Itraconazole and two experimental groups received supra-pharmacological dose of oral Itraconazole (400 mg for 2 weeks and 200 mg for another 2 weeks for Group B) and combination of oral Itraconazole (200 mg for 4 weeks) and Terbinafine (250 mg for 4 weeks in Group C) respectively. The clinical and mycological cure was noticed in every group. Statistical analysis was done with the help of Microsoft Excel and Med Calc 12 software. Results- 41, 42 and 41 patients of respective three groups were completed their last follow-up visits. 78.57% and 73.18% of patients showed cure in Group B and C respectively whereas 4.88% cure in control group. So, both the experimental groups show better outcome compared to the conventional treatment (p<0.001). In the multiple regression model, it is clearly shown that the clinico-mycological cure is dependent on the treatment regime (p = <0.0001), not on the fungal species (p = 0.0622). Limitations- Small sample size and single-centre study were some limitations. Conclusion-Supra-pharmacological dose of oral Itraconazole or a combination of Itraconazole and Terbinafine can be given in recurrent tinea cases.