Topical Lactobacillus reuteri for hair loss due to androgenetic alopecia
Official title: Safety and Efficacy of Lactobacillus Reuteri for Androgenetic Alopecia: A Single-Center, Randomized, Double-Blind, Placebo-Controlled Trial
Run by Shenzhen People's Hospital · NCT07370519 · Data updated 2026-11-12
This trial will test whether applying a topical Lactobacillus reuteri solution can increase hair count and improve hair quality in adults (18–60) with androgenetic alopecia over 12 months.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 388 (estimated) |
| Sponsor | Shenzhen People's Hospital Academic / other |
| Locations | 1 site (Shenzhen, Guangdong) |
| Status | Recruiting |
| Started | January 25, 2026 |
| Main results expected | January 2027 |
| Study ends | June 2027 |
| Registry record updated | April 1, 2026 |
| Trial ID | NCT07370519 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–60 with clinically confirmed androgenetic alopecia (Norwood-Hamilton II–IV or Ludwig I–III), generally healthy, and who have not used hair-loss medications in the prior six months are ideal candidates.
✕Probably not a fit
Patients with long-standing or advanced AGA (>5 years progression), alopecia areata, active scalp disease, uncontrolled diabetes or cardiovascular disease, recent hair-loss treatments, or those unable to attend Shenzhen clinic visits may not receive benefit or are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center, randomized, double-blind, placebo-controlled Phase 2 trial comparing four 12-month topical regimens: live Lactobacillus reuteri, inactivated Lactobacillus reuteri, normal saline placebo, and 5% minoxidil. Participants and outcome assessors are blinded to assignment to reduce bias. The primary outcome is change in hair count per square centimeter after one year, with secondary measures of hair thickness and quality. The trial is based on the hypothesis that rebalancing the scalp microbiome may support hair follicle function and slow or reverse hair thinning.
Why it matters
Potential benefit: If successful, this could offer a new topical, microbiome-based treatment that increases hair count and improves hair quality, potentially with fewer systemic effects than some current options.
How similar studies have gone: Microbiome-targeting approaches for hair loss are largely novel: there is limited preclinical and early clinical evidence suggesting potential benefit but no established proof yet.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients meeting AGA diagnostic criteria (confirmed by medical history, clinical presentation, and trichoscopy) classified as Norwood-Hamilton stage II-IV or Ludwig grade I-III; 2. Provision of informed consent and voluntary participation; 3. Aged 18-60 years with generally good health status; 4. No use of any hair loss medications within the past six months; 5. Absence of alopecia areata, local infections, or neuromuscular disorders. Exclusion Criteria: 1. AGA progression \>5 years; 2. Active skin disease (e.g., psoriasis flare) or uncontrolled diabetes/CVD; 3. Investigator-assessed protocol non-feasibility.
Where it's running
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Shenzhen People's Hospital
Shenzhen, Guangdong, China Recruiting
Study contacts
- Study coordinator: Jianglin Zhang
- Email: zhang.jianglin@szgospital.com
- Phone: +86 13873143466
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.