Androgenetic AlopeciaNCT06994819
Evaluation of the Niostem Headset for Hair Growth and Hair Quality
A study testing niostem headset (Active) in people with Androgenetic Alopecia and Pattern Baldness, run by Mane Biotech GmbH at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Androgenetic Alopecia, Pattern Baldness
- What is being tested?
- niostem headset (Active)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Androgenetic Alopecia, Pattern Baldness
- Being tested
- niostem headset (Active), Sham niostem headset (Placebo)
- 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
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham niostem headset (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months, and 6 months
Secondary outcomes (5)
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
Measured: Baseline, 3 months, and 6 months
Change in Percentage of Anagen and Telogen Hairs
Proportion of anagen-phase and telogen-phase hairs in the target area measured using TrichoScan HD.
Unit of Measure: Percentage
Measured: 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
Measured: 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)
Measured: 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
Measured: Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start1 Oct 2023
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mane Biotech GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06994819
- Sponsor's protocol ID
- ManeNio1.0
- Status last verified
- May 2025
- First submitted
- 7 May 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 40296533Chacon-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.
PubMed 42018094
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06994819
- Acronym / sponsor ID
- ManeNio1.0
- Conditions
- Androgenetic Alopecia, Pattern Baldness
- Keywords
- Hair loss, Alopecia, Androgenetic alopecia, Hair growth, Hair density, Hair quality, Niostem headset, Transcutaneous stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Mane Biotech GmbHIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 29 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: niostem Headset | Experimental | Device: niostem headset (Active)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. |
| Placebo Comparator: Sham Headset | Experimental | Device: Sham niostem headset (Placebo)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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| niostem 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. | Device | Active Comparator: niostem Headset |
| Sham 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. | Device | Placebo Comparator: Sham Headset |
Primary outcome
Incidence of Dermatological Adverse Reactions
Time frame: 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.
5 secondary outcomes
Change in Hair Density (TrichoScan)
Time frame: Baseline, 3 months, and 6 months
Change in Percentage of Anagen and Telogen Hairs
Time frame: Baseline, 3 months, and 6 months
Change in Percentage of Total, Terminal and Vellus Hairs
Time frame: Baseline, 3 months, 6 months
Change in Global Scalp Hair Coverage (Photography)
Time frame: Baseline, 3 months, and 6 months
Participant-Reported Satisfaction with Hair Appearance, Comfort During Use and Perceived Efficacy
Time frame: Baseline, 3 months, and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Background: PubMed 40296533Jellard 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.
- Derived from this study: PubMed 42018094Chacon-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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing niostem headset (Active) in people with Androgenetic Alopecia and Pattern Baldness, run by Mane Biotech GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dermatological Adverse Reactions (time frame: Baseline, 3 months, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06994819, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025.