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Asiatic Acid-Entrapped Transfersomes for the Treatment of Hypertrophic Scars: in Vitro Appraisal, Bioactivity Evaluation, and Clinical Study.

International journal of pharmaceutics(2024)

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摘要
Non-invasive treatment options for hypertrophic scars (HTS) are limited, and treating HTS remains challenging due to their unappealing appearance and associated social stigma. In this work, a novel transfersomal system named Asiatic acid -entrapped transfersomes (AATs) was prepared. AATs were evaluated for their skin permeability, anti-inflammatory activity, and other characteristic parameters to determine the most promising formulation. Asiatic acid -entrapped transfersomal gel (AATG), which was obtained by incorporating the lead AATs in a gel base, underwent testing in an 8 -week, double-blind, placebo -controlled, split -skin clinical study. The net skin elasticity (R5), melanin index (MI), and skin surface hydration were analyzed employing Cutometer (R), Mexameter (R), and Corneometer (R), respectively, in order to evaluate the effectiveness of the developed AATG. AATs exhibited vesicular sizes and zeta potential values within the range of (27.15 +/- 0.95 to 63.54 +/- 2.51 nm) and (-0.010 to -0.129 mV), respectively. TW80AAT gave the highest %EE (90.84 +/- 2.99%), deformability index (101.70 +/- 11.59 mgs � 1), permeation flux at 8 h (0.146 +/- 0.005 mg/cm2/h), and antiinflammatory activity (71.65 +/- 1.83%). The clinical study results of AATG indicated no adverse skin reactions. Furthermore, product efficacy tests demonstrated a significant reduction in MI and an increase in net skin elasticity at 2, 4, and 8 weeks. These pilot study outcomes support the effectiveness of the AATG.
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关键词
Dermal drug delivery,Transfersomes,Anti-inflammatory activity,Hypertrophic scars,Skin elasticity,Melanin index
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