Status:
COMPLETED
Evaluation of the Niostem Headset for Hair Growth and Hair Quality
Lead Sponsor:
Mane Biotech GmbH
Conditions:
Androgenetic Alopecia
Pattern Baldness
Eligibility:
All Genders
18-55 years
Phase:
NA
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 tota...
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 followin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT06994819
Start Date
October 1 2023
End Date
September 30 2024
Last Update
June 22 2025
Active Locations (1)
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1
Dermatest GmbH
Münster, NRW (Nordrhein-Westfalen), Germany, 48163