Efficacy, Safety, and Tolerability of a Wearable Electrotrichogenic Device in Men with Androgenetic Alopecia: A Randomized, Double-Blind, Sham-Controlled Trial
Year: 2026
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: 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. This single-center, randomized, double-blind, sham-controlled clinical trial enrolled 81 men (18–55 years of age; Norwood–Hamilton scale II–VI) assigned to the active ETG or sham group in a 5:3 ratio. Participants used the assigned device 30 min daily for 24 weeks. Efficacy was assessed in a prespecified per-protocol population (treatment compliance ≥ 70%). Outcomes were assessed at baseline, month 3, and month 6 using standardized global photography and trichoscopic analysis. The primary endpoint was the between-group difference in change from baseline to month 6 in total hair density (hairs/cm2). Key secondary endpoints included terminal hair density and cumulative hair thickness (in micrometers). At month 6, total hair density change was significantly greater in the active ETG group than in the sham group (mean difference 24.40 hairs/cm2, 95% confidence interval [CI] 4.90–43.91; p = 0.02; month 6: n = 38 participants in the active ETG group, n = 25 participants in the sham group). Terminal hair density also increased significantly in the active ETG group versus the sham group (mean difference 17.06 hairs/cm2, 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]). 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. ClinicalTrials.gov NCT06994819; registered 29 May 2025 (retrospectively registered). Male pattern hair loss (androgenetic alopecia) is very common and often needs long-term treatment. Many people want evidence-based, non-drug options that they can use at home, either alone or together with standard treatments. In this study, we tested niostem, a wearable device designed to stimulate the scalp with very low electrical signals (electrotrichogenesis). We ran a randomized, double-blind clinical trial in 81 men aged 18–55 years who were assigned to receive treatment with either the active electrotrichogenic (ETG) device or with a look-alike sham device, for 30 min each day for 24 weeks. The study team measured outcomes at the start of the study, after 3 months, and after 6 months using standardized scalp photographs and close-up scalp imaging that counts hairs and measures hair thickness. After 6 months, the active ETG device had improved hair growth more than the sham device: total hair density increased by 24.40 more hairs per square centimeter in the active ETG device group compared with the sham group, terminal (thicker) hair density increased by 17.06 more hairs per square centimeter, and overall hair thickness also improved more with the active device. No serious side effects occurred, and mild tolerability symptoms were uncommon and mostly transient. These results suggest that electrotrichogenesis with a wearable device can be a clinically relevant, non-drug option for people seeking evidence-based alternatives or add-ons to standard hair loss treatments.
Source: Dermatology and Therapy
Language: English
Topic: Hair Growth and Disorders
Subfield: Urology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $7,400
OpenAlex ID: W7155193515