Efficacy Evaluation of Luliconazole‐Loaded Nanostructured Lipid Carriers in Treatment‐Resistant Dermatophytosis: A Randomized Clinical Trial

BACKGROUND: Dermatophytosis is a common superficial fungal infection that is increasingly complicated by terbinafine (TRB)-resistant strains, especially Trichophyton indotineae. Conventional antifungals often show limited efficacy against resistant isolates, highlighting the need for novel treatments. This study evaluated the efficacy and safety of nanostructured lipid carrier-loaded luliconazole (NLC-LCZ) gel in TRB-resistant dermatophytosis. MATERIALS AND METHODS: In a randomized, clinical trial conducted at Touba Specialty Clinic, Sari, Iran, forty-eight adults with confirmed TRB-resistant dermatophytosis were assigned to oral itraconazole (ITZ), topical luliconazole, NLC-LCZ gel, or ITZ + NLC-LCZ gel for 4 weeks (n = 12 each). The primary endpoint was complete recovery (clinical and mycological), while secondary endpoints included lesion size, itch, inflammation, Dermatology Life Quality Index (DLQI), and safety. RESULTS: : 4 μg/mL). DLQI improved most in NLC-LCZ (score: 2) and ITZ + NLC-LCZ (score: 3) groups (p < 0.001). Adverse events were mild and did not require discontinuation. CONCLUSIONS: These findings indicate that NLC-LCZ enhanced antifungal efficacy and quality of life in TRB-resistant dermatophytosis, and that combination therapy with ITZ + NLC-LCZ yielded the highest recovery, representing a promising strategy against resistant infections.