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®, Mexameter®, and Corneometer®, 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 anti-inflammatory 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.
Keywords: Anti-inflammatory activity; Dermal drug delivery; Hypertrophic scars; Melanin index; Skin elasticity; Transfersomes.
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