Efficacy Evaluation of Luliconazole-Loaded Nanostructured Lipid Carriers in Treatment-Resistant Dermatophytosis: A Randomized Clinical Trial
Abstract
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: Complete recovery occurred in 83.3% of ITZ + NLC-LCZ, 75% of NLC-LCZ, 58.3% of LCZ, and 0% of ITZ alone. LCZ and NLC-LCZ had lower MIC50/ MIC90 values (0.016 μg/mL) compared with ITZ (MIC90: 8 μg/mL) and TRB (MIC90: 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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 12 participants or records.
Read the paper
Related studies
- Understanding the factors influencing fall armyworm (Spodoptera frugiperda J.E. Smith) damage in African smallholder maize fields and quantifying its impact on yield. A case study in Eastern Zimbabwe
- Alarming situation of emerging H5 and H7 avian influenza and effective control strategies
- Livestock and food security: vulnerability to population growth and climate change
- Atmosphere–ocean oxygen and productivity dynamics during early animal radiations
- Characterization of the global distribution and diversified plasmid reservoirs of the colistin resistance gene mcr-9
- The global seroprevalence of Toxoplasma gondii in pigs: A systematic review and meta-analysis
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.