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Topical Application of Lactobacillus Reuteri for Androgenetic Alopecia

NCT07370519 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 388

Last updated 2026-04-01

No results posted yet for this study

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.

Conditions

  • Androgenetic Alopecia (AGA)

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.

Sponsors & Collaborators

  • Shenzhen People's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-25
Primary Completion
2027-01-31
Completion
2027-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07370519 on ClinicalTrials.gov