Hypertrophic scars and keloids represent pathological outcomes of wound healing characterized by excessive collagen deposition and persistent myofibroblast activity, necessitating effective therapeutic intervention. 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 days. Scar remodeling was evaluated using histological staining (H&E, Masson’s trichrome), α-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 h, 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 < 0.01), accompanied by decreased α-SMA expression (27–30%), 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.
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