Evaluation of the Niostem Headset for Hair Growth and Hair Quality

Mane Biotech GmbH

Status: Completed

Conditions: Androgenetic Alopecia; Pattern Baldness

Treatments: Device: niostem headset (Active); Device: Sham niostem headset (Placebo)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06994819

ManeNio1.0

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 101 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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101 participants in 2 patient groups

Active Comparator: niostem Headset

Experimental group

Description:

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.

Treatment:

Device: niostem headset (Active)

Placebo Comparator: Sham Headset

Experimental group

Description:

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.

Treatment:

Device: Sham niostem headset (Placebo)