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In this study, a self-polymerizable one-component silicone gel loaded with tranilast was developed and evaluated in a rabbit ear hypertrophic scar model. The formulation was characterized for physicochemical, rheological, and film-forming properties, and its biocompatibility was assessed in accordance with ISO 10993 standards. Hypertrophic scars were induced by punch biopsy on rabbit ears (n = 6), followed by topical treatment with silicone gel alone or tranilast-loaded silicone gel for 40\u00a0days. Scar remodeling was evaluated using histological staining (H&amp;E, Masson\u2019s trichrome), \u03b1-SMA immunohistochemistry, and biochemical quantification of hydroxyproline and glycosaminoglycans. The gel rapidly polymerized on the skin to form a stable solid film and demonstrated favorable biocompatibility. Tranilast release reached approximately 81% within 24\u00a0h, following diffusion-controlled kinetics. Histological analyses revealed reduced epidermal and dermal thickness in treated groups compared to control, with the tranilast-loaded gel showing collagen fiber reorganization closely resembling healthy skin. Hydroxyproline content was significantly reduced in the tranilast group compared to both control and silicone-only groups (p &lt; 0.01), accompanied by decreased \u03b1-SMA expression (27\u201330%), indicating suppression of myofibroblast activity. These findings demonstrate that the self-polymerizable silicone gel provides an effective delivery platform for tranilast, offering synergistic benefits in scar modulation and supporting its potential for advanced topical scar management.<\/jats:p>","DOI":"10.1177\/08853282261432810","type":"journal-article","created":{"date-parts":[[2026,3,13]],"date-time":"2026-03-13T16:58:42Z","timestamp":1773421122000},"page":"568-583","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Development and in vivo evaluation of a self-polymerizable tranilast-loaded silicone gel for scar modulation"],"prefix":"10.1177","volume":"41","author":[{"given":"Farjam","family":"Goudarzi","sequence":"first","affiliation":[{"name":"Kermanshah University of Medical Sciences"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0546-5280","authenticated-orcid":false,"given":"Daniel","family":"Elieh-Ali-Komi","sequence":"additional","affiliation":[{"name":"Charit\u00e9 \u2013 Universit\u00e4tsmedizin Berlin, Corporate Member of Freie Universit\u00e4t Berlin and Humboldt-Universit\u00e4t zu Berlin"},{"name":"Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Immunology and Allergology"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara","family":"Derakhshan","sequence":"additional","affiliation":[{"name":"Kermanshah University of Medical Sciences"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Khodabakhsh","family":"Rashidi","sequence":"additional","affiliation":[{"name":"Kermanshah University of Medical Sciences"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amir","family":"Kiani","sequence":"additional","affiliation":[{"name":"Kermanshah University of Medical Sciences"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2026,3,13]]},"reference":[{"key":"e_1_3_8_2_2","doi-asserted-by":"publisher","DOI":"10.1111\/wrr.12839"},{"key":"e_1_3_8_3_2","doi-asserted-by":"publisher","DOI":"10.1002\/mco2.70381"},{"key":"e_1_3_8_4_2","doi-asserted-by":"publisher","DOI":"10.1080\/17435889.2024.2401768"},{"key":"e_1_3_8_5_2","doi-asserted-by":"publisher","DOI":"10.1007\/s00266-007-9030-9"},{"key":"e_1_3_8_6_2","doi-asserted-by":"publisher","DOI":"10.2147\/IJN.S528531"},{"key":"e_1_3_8_7_2","doi-asserted-by":"publisher","DOI":"10.1016\/0007-1226(92)90008-L"},{"key":"e_1_3_8_8_2","doi-asserted-by":"publisher","DOI":"10.1097\/01.prs.0000195073.73580.46"},{"key":"e_1_3_8_9_2","doi-asserted-by":"publisher","DOI":"10.4103\/ijd.IJD_485_19"},{"key":"e_1_3_8_10_2","volume-title":"Interferon therapy for hypertrophic scars and keloids","author":"Loordhuswamy A","year":"2021","unstructured":"Loordhuswamy A, Santhini E. 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