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Efficacy assessments of tretinoin-loaded nano lipid carriers in acne vulgaris: a double blind, split-face randomized clinical study

Abstract

Here, we assessed the efficacy and safety of Nano lipid carrier (NLC) drug delivery system containing tretinoin (NLC-TRE) in comparison with the conventional 0.05% tretinoin cream (TRE cream) in mild to moderate acne vulgaris. A stable and appropriate NLC-TRE formulation was prepared using a high-pressure homogenizer and particle characterization and physicochemical properties were evaluated under accelerated conditions. Efficacy assessment was performed via a split-face clinical study, by comparing the number of acne lesions, porphyrin production and skin biophysical parameters in both sides of the face randomly treated with NLC-TRE and TRE cream. Plasma concentration of tretinoin after topical application of NLC-TRE was measured for primary safety evaluation. We acquired a stable, spherical nanoparticles with particle size of 118.5 nm, PI equal to 0.485 and ZP of − 44.7 mV. The rate of decrease of acne lesions was significantly higher in NLC- TRE side (p value < 0.001). The size and intensity of porphyrin production in pilosebaceous follicles were significantly reduced only on NLC-TRE side (p value < 0.01). The plasma concentration of the tretinoin, after 8 weeks’ application remained lower than the toxic levels. The NLC-TRE formula provides better efficiency and good loading capacity of TRE in the drug delivery system.

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Authors

Contributions

Conception and design of experiments: SAN, AS, AF, RD. Acquisition of data: AS, ZS, BS. Analysis of data: AS. Interpretation of data: AS, SAN. Drafting the work: AS, ZS, BS. Revising the work: SAN, AF, MNK, MRR.

Corresponding author

Correspondence to Saman Ahmad Nasrollahi.

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The authors have no conflicts of interest to declare.

Statement of Ethics

This study was approved by the Ethics Committee of Tehran University of Medical Sciences under the registration code IR.TUMS.REC.1394.1771. The study protocol was approved by the Committee of Iranian Registry of Clinical Trials on 3/1/2016 under the registration code IRCT20161207031288N2. Data were generated, recorded and processed in accordance with the Declaration of Helsinki and principles of Good Clinical Practice. The method of study was explained to all volunteers, and a written informed consent was obtained.

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Samadi, A., Sartipi, Z., Ahmad Nasrollahi, S. et al. Efficacy assessments of tretinoin-loaded nano lipid carriers in acne vulgaris: a double blind, split-face randomized clinical study. Arch Dermatol Res (2021). https://doi.org/10.1007/s00403-021-02256-5

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Keywords

  • Acne vulgaris
  • Tretinoin
  • Nano lipid carriers
  • Efficacy assessment