Plasma and Sonophoresis-Assisted Topical Delivery of an Exosome for Androgenic Alopecia

Androgenetic alopecia (AGA) is characterized by progressive follicular miniaturization and shortening of the anagen phase, leading to visible scalp hair thinning. Evidence-based pharmacologic options exist, but real‑world outcomes are limited by adherence, tolerability, and patient preference.

To evaluate the clinical effects and safety of a procedure-assisted topical protocol combining an exosome-containing hair growth formulation with plasma and sonophoresis-assisted delivery in patients with androgenetic alopecia (AGA).

This prospective, single-arm pilot study enrolled 25 adults with AGA (16 men and 9 women). Participants received 4 treatment sessions at 2‑week intervals (0, 2, 4, and 6 wk). At each session, an exosome-containing topical formulation (BLESKIN EXXO HAIR; Daeyang Medical, Wonju, Korea) was applied to the target zone, followed by standardized plasma and sonophoresis-assisted scalp stimulation intended to improve the scalp microenvironment and enhance transdermal/transfollicular delivery. Primary endpoints were TrichoScan-measured hair density (hairs/cm2) and mean hair shaft diameter (µm) at baseline and week 12. Secondary endpoints included terminal-to-vellus (T/V) ratio, blinded photographic assessment using the Hair Growth Improvement Scale (HGIS), scalp sebum level, investigator-rated scalp inflammation score, patient satisfaction, and adverse events.

Mean hair density increased from 165.3±32.5 hairs/cm2 at baseline to 182.5±29.8 hairs/cm2 at week 12 (mean change +17.2 hairs/cm2; P<0.01). Mean hair shaft diameter increased from 48.7±6.2 µm to 52.1±5.8 µm, and the T/V ratio improved from 2.1±0.5 to 2.6±0.6. Scalp sebum decreased from 185.5±45.2 to 142.3±38.7 sebumeter units. The median inflammation score decreased from 1 (IQR 1-2) to 0 (IQR 0-1). Blinded photographic assessment showed HGIS ≥ +1 in 72% of participants (18/25) by both evaluators (weighted κ=0.65). Seventeen participants (68%) reported being satisfied or very satisfied. Three participants (12%) reported mild, transient postprocedure erythema resolving within 24 hours; no serious adverse events occurred.

In this 12‑week pilot study, plasma- and sonophoresis-assisted topical delivery of an exosome-containing formulation was associated with improvements in objective TrichoScan metrics, photographic ratings, and scalp physiology measures, with a favorable short‑term safety profile. Controlled trials are needed to confirm efficacy and to isolate the contribution of the delivery modalities.