NCT07370519 Topical Application of Lactobacillus Reuteri for Androgenetic Alopecia
| NCT ID | NCT07370519 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shenzhen People's Hospital |
| Condition | Androgenetic Alopecia (AGA) |
| Study Type | INTERVENTIONAL |
| Enrollment | 388 participants |
| Start Date | 2026-01-25 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 388 participants in total. It began in 2026-01-25 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a single-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate whether topical application of Lactobacillus reuteri can safely and effectively treat androgenetic alopecia. The study is based on the concept that balancing the scalp's microbial community may support hair follicle function. Participants will be randomly assigned to one of four groups receiving either active probiotic solution, inactivated probiotic solution (control for non-viable bacterial effects), a saline placebo, or the standard treatment 5% minoxidil solution for 12 months. Neither participants nor assessing clinicians will know the assigned treatment. The main goal is to measure improvement in hair count per square centimeter after one year. Additional measures include changes in hair thickness and quality. This research seeks to provide high-quality scientific evidence on a new microbiome-targeting approach, offering future patients and healthcare providers insights into a potential alternative or complementary treatment strategy for hair loss.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07370519 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Androgenetic Alopecia (AGA). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07370519 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07370519 currently recruiting?
Yes, NCT07370519 is actively recruiting participants. Contact the research team at zhang.jianglin@szgospital.com for enrollment information.
Where is the NCT07370519 trial being conducted?
This trial is being conducted at Shenzhen, China.
Who is sponsoring the NCT07370519 clinical trial?
NCT07370519 is sponsored by Shenzhen People's Hospital. The trial plans to enroll 388 participants.