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NCT Number: NCT07370519

Topical Application of Lactobacillus Reuteri for Androgenetic Alopecia

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.

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Key information

Conditions

Androgenetic Alopecia (AGA) Alopecia Hair Diseases Hypotrichosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shenzhen People's Hospital

Shenzhen, Guangdong, China

Location status: Recruiting

Location contact

Shenzhen People's Hospital

CONTACT

[email protected]

+86 75522943881

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lactobacillus reuteri

Biological

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.

Inactivated Lactobacillus reuteri

Biological

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.

5% Minoxidil

Drug

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.

normal saline

Drug

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 outcomes

  1. Hair Density

    Time frame: The follow-up periods are set at 1, 3, 6, and 12 months after the initial treatment

    Hair density is quantified by counting all visible growing hairs in a unit area of the scalp using a trichoscope

Secondary outcomes

  1. Hair Diameter

    Time frame: The follow-up periods are set at 1, 3, 6, and 12 months after the initial treatment

    Trichoscopy is used to measure the average hair shaft diameter (cross-sectional thickness) of all growing hairs in a defined scalp area.

Study contacts

Contact information is provided by the study sponsor or research team.

Jianglin Zhang

CONTACT

[email protected]

+86 13873143466

Sponsors and collaborators

Lead sponsor

Shenzhen People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 27, 2026
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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