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

BACKGROUND: 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. OBJECTIVE: 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). METHODS: 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. RESULTS: 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. CONCLUSION: 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.