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NCT06994819

Evaluation of the Niostem Headset for Hair Growth and Hair Quality

Completed NA Last updated 22 June 2025
What this trial tests

NA trial testing niostem headset (Active) in Androgenetic Alopecia in 101 participants. Completed in 30 September 2024.

Timeline
1 October 2023
Primary endpoint
30 September 2024
30 September 2024

Quick facts

Lead sponsorMane Biotech GmbH
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposesupportive care
Enrollment101
Start date1 October 2023
Primary completion30 September 2024
Estimated completion30 September 2024
Sites1 location across Germany

Drugs / interventions tested

Conditions studied

Sponsor

Mane Biotech GmbH

Who can join

Adults 18 to 55, any sex, with Androgenetic Alopecia or Pattern Baldness. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Efficacy, Safety, and Tolerability of a Wearable Electrotrichogenic Device in Men with Androgenetic Alopecia: A Randomized, Double-Blind, Sham-Controlled Trial.
    Chacón-Martínez CA, Pogorelov G, Cabral KK, Emmler T, et al · · 2026 · PMID 42018094 · DOI 10.1007/s13555-026-01747-5

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