At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating niostem headset (Active) and Sham niostem headset (Placebo) for Androgenetic Alopecia and Pattern Baldness. Completed, enrolled 101 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
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.