RecruitingPhase 2NCT07370519

Topical Application of Lactobacillus Reuteri for Androgenetic Alopecia

Safety and Efficacy of Lactobacillus Reuteri for Androgenetic Alopecia: A Single-Center, Randomized, Double-Blind, Placebo-Controlled Trial

Sponsor

Shenzhen People's Hospital

Enrollment

388 participants

Start Date

Jan 25, 2026

Study Type

INTERVENTIONAL

Conditions

Androgenetic alopecia (AGA)

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

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called 5% Minoxidil, a biological treatment called Inactivated Lactobacillus reuteri, and others for people with androgenetic alopecia (aga). The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 60 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALLactobacillus 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.

BIOLOGICALInactivated 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.

DRUG5% 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.

DRUGNormal 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.