Comparative Study Between Pulsed and Continuous Itraconazole for the  Treatment of Onychomycosis

Objective: To compare efficacy of pulsed versus continuous daily oral Itraconazole in the treatment of onychomycosis. Study Design: Randomized Control Trial (ClinicalTrials.gov: NCT05567484). Place and Duration of Study: Department of Dermatology, Combined Military Hospital, Abbottabad, Pakistan, from May to Dec 2021. Methodology: We enrolled 60 patients whose toenails showed signs of onychomycosis (crumbling nail plates, thicker nail beds, and yellowing). They were randomly divided into Group-A and Group-B, with 30 patients each. Group -A (Pulse Therapy) took two capsules of oral Itraconazole 100 mg twice weekly for one week every month for three months while Group-B (Continuous Therapy) received continuous oral 100 mg of Itraconazole once daily for 12 weeks continuously. Patients were subjected to an Onychomycosis Severity Index-based clinical evaluation. Results: In Group-A (Pulse Therapy), 25(83.3%) patients showed mycological cure whereas in Group-B (Continuous Therapy), 23(76.7%) patients showed mycological cure but difference in the efficacy of both drugs was not statistically significant (p-value=0.519). Conclusion: Pulsed therapy with Itraconazole and continuous Itraconazole therapy have comparable efficacies in treating dermatophyte toenail onychomycosis.