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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hair Density (TrichoScan) | Hair density measured in a defined scalp region using TrichoScan HD. Measurement area standardized per participant. Unit of Measure: Hairs per cm² | Baseline, 3 months, and 6 months |
| Change in Percentage of Anagen and Telogen Hairs |
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatest GmbH | Münster | NRW (Nordrhein-Westfalen) | 48163 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40296533 | Background | 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. | |
| 42018094 | Derived | Chacon-Martinez CA, Pogorelov G, Cabral KK, Emmler T, Voss W. Efficacy, Safety, and Tolerability of a Wearable Electrotrichogenic Device in Men with Androgenetic Alopecia: A Randomized, Double-Blind, Sham-Controlled Trial. Dermatol Ther (Heidelb). 2026 Jun;16(6):2997-3011. doi: 10.1007/s13555-026-01747-5. Epub 2026 Apr 22. |
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The results of the clinical study will be published in a peer-reviewed journal. However, individual participant data (IPD) will not be shared due to privacy concerns and the proprietary nature of the device. Summary-level findings will be made publicly available through publication and clinical trial registry updates.
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| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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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.
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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.
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| 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. |
|
Proportion of anagen-phase and telogen-phase hairs in the target area measured using TrichoScan HD. Unit of Measure: Percentage |
| Baseline, 3 months, and 6 months |
| Change in Percentage of Total, Terminal and Vellus Hairs | Total, Terminal and Vellus hair percentage evaluated in the defined target zone using TrichoScan HD. Unit of Measure: Percentage | Baseline, 3 months, 6 months |
| Change in Global Scalp Hair Coverage (Photography) | 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) | Baseline, 3 months, and 6 months |
| Participant-Reported Satisfaction with Hair Appearance, Comfort During Use and Perceived Efficacy | 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 | Baseline, 3 months, and 6 months |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |