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Introduction <p>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&#xa0;wearable electrotrichogenic (ETG) device (niostem) compared with a sham device in men with AGA.</p> Methods <p>This single-center, randomized, double-blind, sham-controlled clinical trial enrolled 81 men (18–55&#xa0;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&#xa0;min daily for 24&#xa0;weeks. Efficacy was assessed in a prespecified per-protocol population (treatment compliance ≥ 70%). Outcomes were assessed at baseline, month&#xa0;3, and month&#xa0;6 using standardized global photography and trichoscopic analysis. The primary endpoint was the between-group difference in change from baseline to month&#xa0;6 in total hair density (hairs/cm<sup>2</sup>). Key secondary endpoints included terminal hair density and cumulative hair thickness (in micrometers).</p> Results <p>At month&#xa0;6, total hair density change was significantly greater in the active ETG group than in the sham group (mean difference 24.40&#xa0;hairs/cm<sup>2</sup>, 95% confidence interval [CI] 4.90–43.91; <i>p</i> = 0.02; month 6: <i>n</i> = 38 participants in the active ETG group, <i>n</i> = 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&#xa0;hairs/cm<sup>2</sup>, 95% CI 3.39–30.73; <i>p</i> = 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; <i>p</i> = 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]).</p> Conclusion <p>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&#xa0;6.</p> Trial Registration <p>ClinicalTrials.gov NCT06994819; registered 29 May 2025 (retrospectively registered).</p>

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

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  • 发表日期：

    2026年4月22日

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  • Carlos A. Chacón-Martínez,
  • Gleb Pogorelov,
  • Kin K. Cabral,
  • Tanja Emmler,
  • Werner Voss

摘要

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

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).

Results

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]).

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).