Evaluation of the Niostem Headset for Hair Growth and Hair Quality

NCT06994819 | Completed DMC

• 1 other identifier: ManeNio1.0
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Androgenetic Alopecia; Pattern Baldness

Keywords

Hair loss; Alopecia; Androgenetic alopecia; Hair growth; Hair density; Hair quality; Niostem headset; Transcutaneous stimulation; Dermatology; Home-use device; Scalp stimulation; Non-invasive treatment; Clinical trial; Pattern baldness

Outcome Measures

Primary Outcomes (1)

• Incidence of Dermatological Adverse Reactions

  Assessment of skin tolerability via dermatological examination, identifying signs such as redness, irritation, pressure marks, or itching. Clinical assessments performed at each visit.

  Baseline, 3 months, and 6 months

Secondary Outcomes (5)

• Change in Hair Density (TrichoScan)

  Baseline, 3 months, and 6 months

• Change in Percentage of Anagen and Telogen Hairs

  Baseline, 3 months, and 6 months

• Change in Percentage of Total, Terminal and Vellus Hairs

  Baseline, 3 months, 6 months

• Change in Global Scalp Hair Coverage (Photography)

  Baseline, 3 months, and 6 months

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

  Baseline, 3 months, and 6 months

Study Arms (2)

Active Comparator: niostem Headset

EXPERIMENTAL

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.

Device: niostem headset (Active)

Placebo Comparator: Sham Headset

EXPERIMENTAL

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.

Device: Sham niostem headset (Placebo)

Interventions

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.

Active Comparator: niostem Headset

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.

Placebo Comparator: Sham Headset

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mane Biotech GmbH: lead

Study Sites (1)

Dermatest GmbH

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

Location

Related Publications (1)

• Jellard S, Moore S, Chacon-Martinez CA. Novel Electrotrichogenic Device Promotes Hair Growth in Men With Androgenetic Alopecia: A Pilot Study. J Cosmet Dermatol. 2025 May;24(5):e70202. doi: 10.1111/jocd.70202.

  PMID: 40296533 BACKGROUND

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 29, 2025
• Study Start: October 1, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: June 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)