Efficacy, Safety, and Tolerability of a Wearable Electrotrichogenic Device in Men with Androgenetic Alopecia: A Randomized, Double-Blind, Sham-Controlled Trial

INTRODUCTION: Androgenetic alopecia (AGA), the most common form of hereditary hair loss, is highly prevalent and commonly requires long-term, consistent treatment. This randomized controlled trial evaluated the efficacy, safety, and tolerability of a wearable electrotrichogenic (ETG) device (niostem) compared with a sham device in men with AGA. METHODS: ). Key secondary endpoints included terminal hair density and cumulative hair thickness (in micrometers). RESULTS: , 95% CI 3.39-30.73; p = 0.02). Percentage change in cumulative hair thickness was significantly greater in the active ETG group than in the sham group (mean difference 26.24 percentage points, 95% CI 5.48-47.01; p = 0.01). No serious adverse events were reported. Tolerability symptoms were uncommon and mostly mild, including itching (6.7% [active ETG] vs 3.4% [sham]), redness (6.7% [active ETG] vs 0.0% [sham]), and scaling/increased dandruff (4.4% [active ETG] vs 6.9% [sham]). CONCLUSION: Daily use of the niostem ETG wearable significantly improved total and terminal hair density and cumulative hair thickness compared to the sham treatment, with effects apparent at month 6. TRIAL REGISTRATION: ClinicalTrials.gov NCT06994819; registered 29 May 2025 (retrospectively registered).