Double-blind Randomized Controlled Clinical Trial Under Dermatological Monitoring on Skin Tolerability and Efficacy of the Niostem Headset on Hair Growth, Hair Loss and Hair Quality After 3 and 6 Months of Daily Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Incidence of Dermatological Adverse Reactions
研究概览
简要总结
This double-blind, randomized, placebo-controlled clinical trial evaluates the Niostem headset, an electronic device designed to support hair growth, reduce hair loss, and improve hair quality. A total of 101 adult participants (20 female, 81 male) aged 18-55 were enrolled. Participants used the device daily for 30 minutes over a six-month period. The primary objective is to assess skin tolerability, and secondary objectives include evaluating usability and efficacy through validated questionnaires, TrichoScan hair analysis, and digital imaging under dermatological supervision.
详细描述
The study is conducted by Dermatest GmbH from October 2023 to September 2024 under dermatological supervision. The Niostem headset is a home-use electronic device applied daily for 30 minutes following standardized protocols. The primary endpoint is skin tolerability, with secondary endpoints assessing usability and potential effects on hair quality and growth.
Dermatological evaluations occur at baseline, 3 months, and 6 months. Quantitative assessments include TrichoScan imaging and digital macro photography, while subjective feedback is collected using validated self-report questionnaires. Participants are adults experiencing pattern hair loss-classified as Norwood stages 2-5 (men) and Ludwig stages I-II (women). Exclusion criteria include scalp conditions, pregnancy, ongoing medication use, and dermatological or psychiatric disorders. The study aims to assess the safety and user experience of a non-chemical, wearable neuromodulation device for cosmetic scalp and hair applications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind design: Participants, care providers, investigators, and outcome assessors were blinded to the assignment of active or placebo devices. The placebo devices visually resembled the active devices but did not deliver stimulation.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female volunteers between 18 and 55 years of age
- •Dermatologically confirmed pattern hair loss (Norwood stages 2-5 for men; Ludwig stages I-II for women)
- •Willingness to comply with daily use of the niostem headset for 6 months
- •No relevant scalp or dermatologic disease at baseline
- •Signed informed consent
排除标准
- •Scalp conditions (e.g., psoriasis, eczema, dermatitis)
- •Use of topical or systemic hair growth treatments within 3 months prior to study
- •Pregnancy or breastfeeding
- •Diagnosed psychiatric or neurologic disorders
- •Participation in another clinical study in the past 30 days
- •Known allergy to electrode gel or materials in the device
结局指标
主要结局
Incidence of Dermatological Adverse Reactions
时间窗: Baseline, 3 months, and 6 months
Assessment of skin tolerability via dermatological examination, identifying signs such as redness, irritation, pressure marks, or itching. Clinical assessments performed at each visit.
次要结局
- Change in Percentage of Anagen and Telogen Hairs(Baseline, 3 months, and 6 months)
- Change in Hair Density (TrichoScan)(Baseline, 3 months, and 6 months)
- Change in Percentage of Total, Terminal and Vellus Hairs(Baseline, 3 months, 6 months)
- Change in Global Scalp Hair Coverage (Photography)(Baseline, 3 months, and 6 months)
- Participant-Reported Satisfaction with Hair Appearance, Comfort During Use and Perceived Efficacy(Baseline, 3 months, and 6 months)