Development and Evaluation of a Niosome-Integrated Microneedle System for Targeted Follicular Delivery of Ketoconazole in Alopecia Therapy

This study presents a novel transdermal delivery system for treating androgenic alopecia (AGA) using ketoconazole-loaded niosomes integrated into a dissolving microneedle array made from polyvinyl alcohol and gelatin. The optimized niosomes achieved a particle size of 201 ± 0.3 nm and an entrapment efficiency of 86 ± 0.63%. The microneedles effectively penetrate the skin, creating micro-channels for direct drug delivery to hair follicles. In vitro and ex vivo studies demonstrated a controlled, two-phase drug release over 24 hours, with a higher localized drug retention of 73.33% compared to 52.39% for pure drug-loaded microneedles. In vivo animal studies showed improved hair growth, with increased hair shaft diameter, thickness, and follicular elongation. This microneedle system offers a promising solution to the limitations of current topical AGA treatments.