Evaluation of the Niostem Headset for Hair Growth and Hair Quality

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-09-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Androgenetic Alopecia Pattern Baldness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This was a parallel assignment study in which participants were randomly assigned to either the active niostem headset group or a placebo group. Both groups used their assigned device daily for 30 minutes over a period of 6 months. The study was conducted under double-blind conditions to evaluate skin tolerability and efficacy in reducing hair loss and promoting hair growth.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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Active Comparator: niostem Headset

Participants in this arm received the active niostem headset, a wearable electronic device designed to reduce hair loss and improve hair growth and quality. The device was applied once daily for 30 minutes over a 6-month period. Stimulation was administered through scalp-contact brush electrodes activated via a connected app.

Group Type EXPERIMENTAL

niostem headset (Active)

Intervention Type 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.

Placebo Comparator: Sham Headset

Participants in this arm received a placebo version of the niostem headset, which looked identical to the active device but did not deliver electrical stimulation. The sham device was worn once daily for 30 minutes over a 6-month period. This allowed the study to remain double-blind and helped assess the true efficacy of the active intervention.

Group Type EXPERIMENTAL

Sham niostem headset (Placebo)

Intervention Type 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.

Interventions

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niostem headset (Active)

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.

Intervention Type DEVICE

Sham niostem headset (Placebo)

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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes