Efficacy and Safety of Conventional Versus Super-bioavailable Itraconazole in Dermatophytic Infections: A Prospective Randomized Comparative Study.

BACKGROUND

Dermatophytosis has emerged as a therapeutic challenge in recent years due to suboptimal response to conventional antifungal therapy and frequent relapses. While conventional itraconazole (C-ITZ) remains a mainstay of treatment, super-bioavailable itraconazole (SB-ITZ) has emerged as a promising alternative with improved pharmacokinetics. This study compares the efficacy and safety of C-ITZ and SB-ITZ in the management of dermatophytosis.

MATERIALS AND

METHODS

This prospective, randomized, open-label, parallel-group comparative study included 108 patients with clinically and mycologically confirmed dermatophytosis involving >20% body surface area. Participants were randomized to receive either C-ITZ 100 mg twice daily or SB-ITZ 50 mg twice daily for four to six weeks. Clinical, mycological, and complete cure rates were assessed at four and six weeks. Safety profile and relapse rates were also evaluated.

RESULTS

Complete cure rates were low at four weeks in both groups. At six weeks, most patients in both groups achieved clinical and mycological cures. Although cure rates were numerically higher in the SB-ITZ group, no statistically significant difference was observed between the two formulations overall. In recalcitrant dermatophytosis, SB-ITZ demonstrated a significantly higher clinical cure rate at six weeks (p = 0.029), while mycological cure and relapse rates were similar. Adverse events were more frequent in the C-ITZ group.

CONCLUSIONS

SB-ITZ and C-ITZ showed comparable overall efficacy in dermatophytosis. SB-ITZ demonstrated a modest clinical advantage in recalcitrant cases with better tolerability. Treatment duration, adherence, and hygiene practices remain key determinants of long-term outcomes.