CompletedNot Applicable

Evaluation of the Niostem Headset for Hair Growth and Hair Quality

Germany101 participantsStarted 2023-10-01

Plain-language 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.

Who can participate

Age range18 Years – 55 Years

SexALL

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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

What they're measuring

Incidence of Dermatological Adverse Reactions

Timeframe: Baseline, 3 months, and 6 months

Trial details

NCT IDNCT06994819

SponsorMane Biotech GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-09-30

View on ClinicalTrials.gov More Androgenetic Alopecia trials