Publication:

Efficacy and safety of combined lactoferrin and luliconazole therapy compared with luliconazole alone in fungal skin infections: a prospective, randomized and active-controlled study

Background Fungal skin infections are a prevalent global health concern, affecting millions and often impairing quality of life. Standard antifungal therapies, including azoles, are increasingly limited by rising resistance and biofilm-mediated tolerance. Lactoferrin, an iron-chelating glycoprotein with antimicrobial and antifungal synergy, may enhance therapeutic outcomes. Sequential application of lactoferrin with luliconazole, a potent topical azole, offers a potential strategy to improve biofilm inhibition and accelerate clinical and mycological cure.

Methods This prospective, randomized, open-label, single-center clinical trial included 60 adults with KOH-confirmed cutaneous candidiasis or dermatophytosis. Participants were randomized 1:1 to receive either sequential lactoferrin with luliconazole (Group A) or luliconazole alone (Group B) for 14 days. Outcomes included biofilm inhibition, mycological and clinical cure, and lesion size reduction. Assessments were performed at baseline, Day 7, and Day 14. Safety was evaluated through adverse event monitoring.

Results Sixty patients were randomized and analyzed. Baseline demographic characteristics were comparable between groups. Biofilm inhibition was significantly greater in Group A at Day 7 (45.45% vs 19.64%) and Day 14 (90.90% vs 58.92%; p<0.001). Mycological cure reached 96.66% in both groups by Day 14, while clinical cure was higher in Group A (80% vs 40%; p<0.05). Lesion size reduction was greater in Group A (80.56% vs 65.44%; p=0.004). Adverse events were mild and fewer in Group A.

Conclusions These findings indicate that lactoferrin, when used alongside standard antifungal treatment, showed beneficial effect on biofilm inhibition, supporting its use as a promising adjunctive therapy in superficial fungal infections.