the efficacy of isotretinoin-loaded solid lipid nanoparticles in comparison to isotrex® on acne treatment

topical retinoids are considered as the first line therapy in the treatment of acne vulgaris, but they are associated with cutaneous irritation. in this study, isotretinoin-loaded solid lipid nanoparticles(it-sln) were prepared to treat the mild to moderate acne. also using it-sln would minimize it adverse effects in comparison to commercial product, isotrex®. this study was conducted to prepare and characterize it-sln and assessing the efficiency of it-sln comparing to isotrex® acne. it-sln was prepared using hot high pressure homogenization method.  it-sln contained 0.05% it in 5% of lipid phase (glyceryl monostearate- gms) and tween 80 (2.5 % w/v) was used as surfactant in the aqueous phase. it-sln was characterized by particle size analyzing, differential scanning calorimetry and transmission electron microscopy. encapsulation efficacy was also obtained using spectrophotometry. the efficacy of it-sln was evaluated in a randomized, single-blind, parallel-group study and compared with isotrex®. forty patients encountered in the study and divided in two groups. treatment regimen was once-nightly topical administration accompanied with topical administration of clindamycin 2% solution twice a day for 8 weeks. the particle size of it-sln was around 60 nm with pdi of 0.4 and zeta potential was about -40 mv. encapsulation efficacy of it in sln in crystalline form was 84±0.21%. it-sln produced significantly better treatment than isotrex® in both non-inflammatory and inflammatory lesions according to its recovery percent after 8 weeks. also it-sln gained better global assessment scores. our results showed that it-sln had higher efficacy than isotrex® to clear non-inflammatory and inflammatory lesions.