Safety Assessment of Tretinoin Loaded Nano Emulsion and Nanostructured Lipid Carriers: A Non-invasive Trial on Human Volunteers.

BACKGROUND AND AIM: Topical application of tretinoin (TRE) is followed by a high incidence of side effects. One method to overcome the problem is loading TRE into lipid nanoparticles. The potential safety of the nanoparticle materials has been always considered as a major concern. In this in vivo study, changes in human skin biophysical parameters including hydration, TEWL, erythema, and pH have been used to determine the safety of tretinoin loaded nano emulsion (NE) and nanostructured lipid carriers (NLC).

METHOD: TRE loaded NE and NLC were prepared using a high pressure homogenizer. Skin biophysical parameters were measured on the volar forearms of twenty healthy volunteers, before and after applying TRE-NE and TRE-NLC lotions. All the measurements were done using respective probes of MPA 580Cutometer®.

RESULT: We obtained particles of nanometric size (<130 nm) with narrow distribution and optimal physical stability. None of the formulations made any statistically significant change in any of the measured skin properties. P-values were 0.646, 0.139, 0.386, 0.169 after applying TRE-NE and 0.508, 0.051, 0.139, 0.333 after applying TRE-NLC, respectively.

CONCLUSION: Both formulations are reasonably safe to apply on human skin and topical application of TRE-NE and TRE-NLC had almost similar effects on skin biophysical parameters.