Clinical trial NCT06994819: Evaluation of the Niostem Headset for Hair Growth and Hair Quality
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alopecia Areata
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
Lead sponsor: Mane Biotech GmbH
Sponsor class: INDUSTRY
First posted: 2025-05-29
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Dermatological Adverse Reactions
timeFrame: Baseline, 3 months, and 6 months
Secondary outcomes:
measure: Change in Hair Density (TrichoScan)
timeFrame: Baseline, 3 months, and 6 months
measure: Change in Percentage of Anagen and Telogen Hairs
timeFrame: Baseline, 3 months, and 6 months
measure: Change in Percentage of Total, Terminal and Vellus Hairs
timeFrame: Baseline, 3 months, 6 months
measure: Change in Global Scalp Hair Coverage (Photography)
timeFrame: Baseline, 3 months, and 6 months
measure: Participant-Reported Satisfaction with Hair Appearance, Comfort During Use and Perceived Efficacy
timeFrame: Baseline, 3 months, and 6 months
Other outcomes:
Locations:
city: Münster
country: Germany
facility: Dermatest GmbH
state: NRW (Nordrhein-Westfalen)
Study officials:
References:
citation: 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.