Topical Application of Lactobacillus Reuteri for Androgenetic Alopecia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lactobacillus reuteri, Inactivated Lactobacillus reuteri, 5% Minoxidil, Normal Saline.
- Who it may be relevant to
- Registry conditions: Androgenetic Alopecia (AGA). Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Safety and Efficacy of Lactobacillus Reuteri for Androgenetic Alopecia: A Single-Center, Randomized, Double-Blind, Placebo-Controlled Trial
Overview
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.
Interventions
- Biological Lactobacillus reuteri
Daily application of 1 sachet containing Lactobacillus reuteri powder (≈10\^9 CFU) dissolved in 1 mL normal saline within a brown glass vial. After thorough mixing, 1 mL of the probiotic solution was topically applied to the scalp using cotton swabs following scalp cleansing. Participants refrained from hair washing for ≥6 hours post-application. Applied once daily for 12 months. - Biological Inactivated Lactobacillus reuteri
Daily application of 1 sachet containing inactivated Lactobacillus reuteri powder (≈10\^9 CFU pre-inactivation) dissolved in 1 mL normal saline within a brown glass vial. After thorough mixing, 1 mL of the solution was topically applied to the scalp using cotton swabs following scalp cleansing. Participants refrained from hair washing for ≥6 hours post-application. Applied once daily for 12 months. - Drug 5% Minoxidil
Commercially available 5% minoxidil was aliquoted into brown glass vials (1 mL/vial). Following daily scalp cleansing, 1 mL solution was topically applied to the scalp. Participants refrained from hair washing for ≥6 hours post-application. Applied once daily for 12 months. - Drug Normal Saline
Normal saline was aliquoted into brown glass vials (1 mL/vial). Following daily scalp cleansing, 1 mL solution was topically applied to the scalp using cotton swabs. Participants refrained from hair washing for ≥6 hours post-application. Applied once daily for 12 months.
Primary outcome measures
- Hair Density [Time frame: The follow-up periods are set at 1, 3, 6, and 12 months after the initial treatment]
Secondary outcome measures (1)
- Hair Diameter [Time frame: The follow-up periods are set at 1, 3, 6, and 12 months after the initial treatment]
Eligibility criteria
Inclusion criteria
- 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;
- Provision of informed consent and voluntary participation;
- Aged 18-60 years with generally good health status;
- No use of any hair loss medications within the past six months;
- Absence of alopecia areata, local infections, or neuromuscular disorders.
Exclusion criteria
- AGA progression >5 years;
- Active skin disease (e.g., psoriasis flare) or uncontrolled diabetes/CVD;
- Investigator-assessed protocol non-feasibility.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shenzhen People's Hospital — Shenzhen
Identifiers
NCT: NCT07370519 · LL-KY-2025109-02