Clinical translation of polymeric microneedles for bioactive nanovesicle delivery in hypertrophic scar remodeling.

Authors

Ming Yu Chang, Bo Zhi Chen, Ling Liang, Xue Ying Chen, Li Yuan, Zhan Tao Wang, Chao Fan Wu, Youchen Xia, Huan Huan Wu, Xin Dong Guo

Published in

Biomaterials science. Sep 21, 2026. Epub Sep 21, 2026.

Abstract

The clinical translation of polymeric microneedle (MN)-based delivery systems for fibrotic diseases remains largely unexplored despite extensive preclinical advances. The dense extracellular matrix of pathological scars constitutes a formidable biophysical barrier that limits homogeneous macromolecular permeation. Here, we conducted a prospective, single-center, open-label, single-arm study evaluating a 12-week protocol combining microplasma radiofrequency (RF), poly(L-lactic acid) (PLLA) MNs, and topical milk-derived bioactive nanovesicles (mBNVs) in 26 patients with hypertrophic scars. Clinical scales and multimodal imaging were used to assess treatment-associated changes. At week 12, the combined protocol was associated with reductions in VSS and POSAS Patient Scale scores, scar stiffness and thickness, and dermoscopic vascular and pigmentation densities. MN-induced microchannels underwent rapid closure, treatment-related reactions were mild and transient, and no serious or systemic adverse events were observed. Collectively, these findings support the short-term feasibility, tolerability, and preliminary clinical activity of the combined protocol, offering a safe and non-steroidal paradigm for mechanically resistant pathological tissues.

PMID:
42765643
Bibliographic data and abstract were imported from PubMed on 21 Sep 2026.

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