Jellard Samuel, Moore Stephanie, Chacón-Martínez Carlos Andrés
Mane Biotech GmbH, Cologne, Germany.
Surrey Trichology Clinic, Surrey, UK.
J Cosmet Dermatol. 2025 May;24(5):e70202. doi: 10.1111/jocd.70202.
Androgenetic alopecia (AGA) is the most common cause of hair loss globally, affecting millions of people, particularly men. Current treatments include FDA-approved drugs and devices, but many patients experience side effects or suboptimal results. The niostem device is a new, wearable device that delivers low-level electrical stimulation to promote hair growth. This pilot study aims to evaluate the efficacy and safety of the niostem device in male AGA patients.
A total of 21 male patients with AGA used the niostem device daily for 30 min over 6 months. Participants had not used any anti-hair loss products within the 6 months preceding the start of the study. Hair density, thickness, and terminal hair counts were assessed at baseline, 3 months, and 6 months using trichoscopic measurements. Patient-reported outcomes were recorded, and adverse events were monitored.
The niostem device resulted in significant increases in hair count, with a 12% increase in total hair density at 3 months and a 19.3% increase at 6 months. Hair thickness also increased by 8.8% in 6 months. Terminal hair density improved significantly over time, with visible hair growth observed in the participants. No adverse events were reported.
The niostem device demonstrated a significant increase in hair density and hair thickness in male AGA patients, with no adverse effects. Further large-scale studies are warranted.
雄激素性脱发(AGA)是全球最常见的脱发原因,影响着数百万人,尤其是男性。目前的治疗方法包括美国食品药品监督管理局(FDA)批准的药物和器械,但许多患者会出现副作用或效果不理想的情况。Niostem设备是一种新型可穿戴设备,可提供低水平电刺激以促进头发生长。这项初步研究旨在评估Niostem设备对男性AGA患者的疗效和安全性。
共有21名男性AGA患者在6个月内每天使用Niostem设备30分钟。参与者在研究开始前的6个月内未使用过任何抗脱发产品。在基线、3个月和6个月时使用毛发镜测量评估头发密度、厚度和终毛数量。记录患者报告的结果,并监测不良事件。
Niostem设备使头发数量显著增加,3个月时总头发密度增加了12%,6个月时增加了19.3%。6个月内头发厚度也增加了8.8%。终毛密度随时间显著改善,参与者中观察到明显的头发生长。未报告不良事件。
Niostem设备在男性AGA患者中显示出头发密度和头发厚度显著增加,且无不良影响。有必要进行进一步的大规模研究。