Asiatic acid-entrapped transfersomes for the treatment of hypertrophic scars: In vitro appraisal, bioactivity evaluation, and clinical study.

Shakthi Apsara Thejani Opatha, Romchat Chutoprapat, Pichanon Khankaew, Varin Titapiwatanakun, Warintorn Ruksiriwanich, Korawinwich Boonpisuttinant

Journal: International journal of pharmaceutics 2024;651():123738

PMID: 38158144

Abstract

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), permeation flux at 8 h (0.146 ± 0.005 mg/cm/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.

Copyright © 2023 Elsevier B.V. All rights reserved.

Address: Pharmaceutical Sciences and Technology Program, Faculty of Pharmaceutical Sciences, Chulalongkorn University, Bangkok 10330, Thailand; Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmaceutical Sciences, Chulalongkorn University, Bangkok 10300, Thailand.; Pharmaceutical Sciences and Technology Program, Faculty of Pharmaceutical Sciences, Chulalongkorn University, Bangkok 10330, Thailand; Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmaceutical Sciences, Chulalongkorn University, Bangkok 10300, Thailand. Electronic address: [email protected].; Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmaceutical Sciences, Chulalongkorn University, Bangkok 10300, Thailand.; Department of Pharmaceutical Sciences, Faculty of Pharmacy, Chiang Mai University, Chiang Mai 50200, Thailand; Center of Excellence in Agro Bio-Circular-Green Industry (Agro BCG), Agro-Industry, Chiang Mai University, Chiang Mai 50100, Thailand; Lanna Rice Research Center, Chiang Mai University, Chiang Mai 50200, Thailand.; Innovative Natural Products from Thai Wisdoms (INPTW), Faculty of Integrative Medicine, Rajamangala University of Technology Thanyaburi, Pathumthani, 12130, Thailand.
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