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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
101
The niostem headset is a non-invasive electronic stimulation device designed to reduce hair loss and improve hair growth. It delivers low-level electrical stimulation through brush electrodes that contact the scalp. Used once daily for 30 minutes for 6 months. Sessions are guided via a smartphone app.
he sham niostem headset is visually identical to the active device but does not deliver electrical stimulation. Used once daily for 30 minutes for 6 months. Allows for blinding and placebo-controlled comparison.
Dermatest GmbH
Münster, NRW (Nordrhein-Westfalen), Germany
Incidence of Dermatological Adverse Reactions
Assessment of skin tolerability via dermatological examination, identifying signs such as redness, irritation, pressure marks, or itching. Clinical assessments performed at each visit.
Time frame: Baseline, 3 months, and 6 months
Change in Hair Density (TrichoScan)
Hair density measured in a defined scalp region using TrichoScan HD. Measurement area standardized per participant. Unit of Measure: Hairs per cm²
Time frame: Baseline, 3 months, and 6 months
Change in Percentage of Anagen and Telogen Hairs
Proportion of anagen-phase and telogen-phase hairs in the target area measured using TrichoScan HD. Unit of Measure: Percentage
Time frame: Baseline, 3 months, and 6 months
Change in Percentage of Total, Terminal and Vellus Hairs
Total, Terminal and Vellus hair percentage evaluated in the defined target zone using TrichoScan HD. Unit of Measure: Percentage
Time frame: Baseline, 3 months, 6 months
Change in Global Scalp Hair Coverage (Photography)
Standardized macro photographs taken at baseline and 24 weeks, evaluated for visual changes in overall hair coverage. Unit of Measure: Visual photographic comparison (qualitative assessment)
Time frame: Baseline, 3 months, and 6 months
Participant-Reported Satisfaction with Hair Appearance, Comfort During Use and Perceived Efficacy
Self-reported satisfaction scores, comfort levels and participants' perception of effectiveness in hair regrowth through standardized questionnaires. Unit of Measure: Score on a structured Likert scale
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Time frame: Baseline, 3 months, and 6 months