Androgenetic Alopecia, Pattern Baldness
Conditions
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
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.
Detailed 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.
Interventions
DEVICEniostem 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.
DEVICESham 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.
Sponsors
Mane Biotech GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Dermatological Adverse Reactions | Baseline, 3 months, and 6 months | Assessment of skin tolerability via dermatological examination, identifying signs such as redness, irritation, pressure marks, or itching. Clinical assessments performed at each visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hair Density (TrichoScan) | Baseline, 3 months, and 6 months | Hair density measured in a defined scalp region using TrichoScan HD. Measurement area standardized per participant. Unit of Measure: Hairs per cm² |
| Change in Percentage of Anagen and Telogen Hairs | Baseline, 3 months, and 6 months | Proportion of anagen-phase and telogen-phase hairs in the target area measured using TrichoScan HD. Unit of Measure: Percentage |
| Change in Percentage of Total, Terminal and Vellus Hairs | Baseline, 3 months, 6 months | Total, Terminal and Vellus hair percentage evaluated in the defined target zone using TrichoScan HD. Unit of Measure: Percentage |
| Change in Global Scalp Hair Coverage (Photography) | Baseline, 3 months, and 6 months | Standardized macro photographs taken at baseline and 24 weeks, evaluated for visual changes in overall hair coverage. Unit of Measure: Visual photographic comparison (qualitative assessment) |
| Participant-Reported Satisfaction with Hair Appearance, Comfort During Use and Perceived Efficacy | Baseline, 3 months, and 6 months | Self-reported satisfaction scores, comfort levels and participants' perception of effectiveness in hair regrowth through standardized questionnaires. Unit of Measure: Score on a structured Likert scale |
Countries
Germany
Outcome results
None listed