CLINICAL OUTCOMES OF SUPER-BIOAVAILABLE 130 MG VERSUS CONVENTIONAL 200 MG ORAL ITRACONAZOLE IN DERMATOPHYTOSIS: A RANDOMISED CONTROLLED TRIAL

Background: Dermatophytosis has become increasingly recalcitrant and relapsing in India, posing therapeutic challenges. Itraconazole remains a key systemic agent, but its conventional formulation exhibits variable absorption. A super-bioavailable (SB) formulation of itraconazole has demonstrated improved pharmacokinetics, but its clinical advantage over the conventional formulation remains underexplored. Objectives: To compare clinical efficacy and quality-of-life outcomes of SB itraconazole 130 mg once daily versus conventional itraconazole 200 mg once daily in adults with tinea infections. Methods: In this hospital-based, prospective, randomised controlled trial (CTRI/2023/10/058852), 200 adults with KOH-positive tinea infection were randomised 1:1 to receive SB itraconazole 130 mg (Group A) or conventional itraconazole 200 mg (Group B) once daily for 6 weeks. Treatment response was assessed at follow-up visits scheduled at 3 weeks, 6 weeks, and a final follow-up at 12 weeks. Results: At baseline, both groups had comparable disease burden (mean composite scores: Group A12.5 ± 4.0 vs Group B 13.0 ± 4.1, p > 0.05). By Week 3, Group A showed significantly greater clinical improvement (mean score 4.20 vs 6.68, p = 0.001). At Week 6, Group A maintained superiority (mean score 2.44 vs 3.38, p = 0.001) and achieved higher DLQI normalisation rates (83% vs 75%). By Week 12, both groups maintained low disease burden, with no statistically significant difference in composite scores (p = 0.10). Conclusion: Super-bioavailable itraconazole 130 mg once daily demonstrated faster clinical clearance and superior quality-of-life improvement compared to conventional itraconazole 200 mg. It represents a promising therapeutic advancement for effective management of dermatophytosis.