Topical Application of Lactobacillus Reuteri for Androgenetic Alopecia
ConditionAndrogenetic Alopecia (AGA)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorShenzhen People's Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
AGA progression >5 years;
Active skin disease (e.g., psoriasis flare) or uncontrolled diabetes/CVD;
Investigator-assessed protocol non-feasibility.
Trial design
Design model
Parallel
Treatments tested in this trial
Lactobacillus reuteri
Biological/VaccineDaily 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/VaccineDaily 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
DrugCommercially 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
DrugNormal 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.
Treatment groups
388 Participants
are divided into 4 treatment groupsGroup A: Test GroupExperimental treatment 1 intervention
Group B: Inactivated Control GroupOther 1 intervention
Group C: Positive Control GroupActive comparator 1 intervention
Group D: Negative Control GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Hair Density
Hair density is quantified by counting all visible growing hairs in a unit area of the scalp using a trichoscope
Time frame
The follow-up periods are set at 1, 3, 6, and 12 months after the initial treatmentSecondary outcomes
1
Hair Diameter
Trichoscopy is used to measure the average hair shaft diameter (cross-sectional thickness) of all growing hairs in a defined scalp area.
Time frame
The follow-up periods are set at 1, 3, 6, and 12 months after the initial treatmentSponsors and contacts
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Source ClinicalTrials.gov