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NCT Number: NCT06994819

Evaluation of the Niostem Headset for Hair Growth and Hair Quality

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.

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Key information

Conditions

Androgenetic Alopecia Alopecia Hair Diseases Hypotrichosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pattern Baldness Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dermatest GmbH

Münster, NRW (Nordrhein-Westfalen), 48163, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

niostem headset (Active)

Device

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.

Sham niostem headset (Placebo)

Device

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.

Primary outcomes

  1. Incidence of Dermatological Adverse Reactions

    Time frame: 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.

Secondary outcomes

  1. Change in Hair Density (TrichoScan)

    Time frame: Baseline, 3 months, and 6 months

    Hair density measured in a defined scalp region using TrichoScan HD. Measurement area standardized per participant.

    Unit of Measure: Hairs per cm²

  2. Change in Percentage of Anagen and Telogen Hairs

    Time frame: Baseline, 3 months, and 6 months

    Proportion of anagen-phase and telogen-phase hairs in the target area measured using TrichoScan HD.

    Unit of Measure: Percentage

  3. Change in Percentage of Total, Terminal and Vellus Hairs

    Time frame: Baseline, 3 months, 6 months

    Total, Terminal and Vellus hair percentage evaluated in the defined target zone using TrichoScan HD.

    Unit of Measure: Percentage

  4. Change in Global Scalp Hair Coverage (Photography)

    Time frame: Baseline, 3 months, and 6 months

    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)

  5. Participant-Reported Satisfaction with Hair Appearance, Comfort During Use and Perceived Efficacy

    Time frame: Baseline, 3 months, and 6 months

    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

Sponsors and collaborators

Lead sponsor

Mane Biotech GmbH

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 29, 2025
Registry last updated
Jun 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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