Publication:

Comparative safety and efficacy evaluation of terbinafine and itraconazole: dose-based monotherapy versus combination therapy in the management of dermatophytosis: a pilot study in Bangladesh

Background Dermatophytosis is highly prevalent in South Asia and increasingly chronic and treatment‑resistant, with poor responses to standard systemic regimens in Bangladesh. This study compared dose‑based terbinafine and itraconazole monotherapies and their combination to identify an optimal regimen.

Methods In a randomized, open‑label, parallel‑group trial at a tertiary hospital, adults (18-60 years) with KOH‑confirmed tinea corporis/cruris/faciei were assigned to: T1 (terbinafine 250 mg/day), I1 (itraconazole 200 mg/day), T+I (terbinafine 250 mg+itraconazole 200 mg/day), T2 (terbinafine 500 mg/day), or I2 (itraconazole 400 mg/day). Follow‑up at weeks 2, 4, 6 and 8 assessed total symptom score (itching, erythema, scaling; 0-9), Physician global assessment, composite cure (clinical plus negative KOH) and safety.

Results One hundred fifty patients (30/group) were randomized with comparable baselines. Symptom scores declined significantly in all arms (p<0.001 within‑group). Week‑8 composite cure was highest with I2 (96.3%), followed by T+I (89.7%) and I1 (83.3%); T1 and T2 had higher failure (both 51.9%). Adverse events were mild and infrequent.

Conclusions Itraconazole, particularly 400 mg/day, achieved the best efficacy with good tolerability, whereas escalating terbinafine to 500 mg/day conferred no benefit. Treatment of contemporary dermatophytosis in Bangladesh should prioritise itraconazole‑based regimens.