Exosomes, nanoscale extracellular vesicles released by nearly all cell types, have attracted substantial interest as potential diagnostic and therapeutic tools in dermatology due to their ability to selectively transport proteins, nucleic acids and lipids between cells. Experimental studies have demonstrated exosome involvement in immune signalling, inflammation, pigmentation, wound repair, hair biology and tumour behaviour, supporting their broad but still largely experimental relevance across dermatologic disease processes. However, despite rapid scientific progress, clinical translation remains at an early stage. Most evidence supporting dermatologic applications is derived from in vitro or animal studies, and few well-designed, adequately powered human trials exist. As of September 2025, only a small number of exosome-based clinical studies in dermatology have been completed, and no exosome therapeutic has received FDA approval. Major challenges-including the lack of standardized isolation and manufacturing methods, batch-to-batch variability, limited mechanistic understanding, inconsistent regulatory frameworks and unresolved safety considerations-continue to impede clinical adoption. Current clinical trials, although promising, are heterogeneous and often underpowered, with insufficient long-term safety and efficacy data to support routine use. Collectively, exosomes represent a compelling but still developmental platform for precision dermatology. Their successful integration into clinical practice will require rigorous mechanistic studies, harmonized quality control standards and large, high-quality randomized controlled trials to confirm therapeutic benefit, ensure safety and enable regulatory approval.
Moslehi et al. (Tue,) studied this question.