A safety and efficacy of oral itraconazole and oral itraconazole with isotretinoin in chronic and recurrent dermatophytosis- A randomized trial

Background: A significant rise in chronic and recalcitrant dermatophytosis unresponsive to standard antifungals at recommended doses and durations has been observed in recent years. This growing resistance underscores the need for newer adjuvant therapies, such as combining isotretinoin with itraconazole. Aims and Objectives: The aim of the study was to evaluate the safety and efficacy of oral itraconazole versus itraconazole with isotretinoin in chronic and recurrent dermatophytosis. Materials and Methods: Patients were randomized into two groups. Group A received itraconazole 200 mg orally daily for 4 weeks, while Group B received itraconazole plus isotretinoin 20 mg daily. Results: Of 70 patients enrolled, 64 (33 in Group A, 31 in Group B) completed the study. Group B demonstrated a significant reduction in Clinical Assessment Score at 4 weeks (P=0.007). Excellent (>80%) improvement in Global Assessment Index was achieved in 58% of Group A and 78% of Group B (P=0.011). Patient satisfaction was higher in Group B (83.8%) compared to Group A (57.5%) (P=0.03). Mycological cure on potassium hydroxide was obtained in 63.6% of Group A and 90.3% of Group B (P=0.012). Relapse rates at 2month follow up were significantly lower in Group B (P=0.014). Conclusion: The combination of oral isotretinoin and itraconazole was more effective than itraconazole monotherapy in achieving clinical and mycological cure, improving patient satisfaction, and reducing relapse in chronic, recurrent dermatophytosis.