Androgenetic Alopecia (AGA)
Conditions
Keywords
Androgenetic Alopecia, Lactobacillus reuteri
Brief 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.
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.
Sponsors
Shenzhen People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. 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; 2. Provision of informed consent and voluntary participation; 3. Aged 18-60 years with generally good health status; 4. No use of any hair loss medications within the past six months; 5. Absence of alopecia areata, local infections, or neuromuscular disorders.
Exclusion criteria
1. AGA progression \>5 years; 2. Active skin disease (e.g., psoriasis flare) or uncontrolled diabetes/CVD; 3. Investigator-assessed protocol non-feasibility.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hair Density | 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
| Measure | Time frame | Description |
|---|---|---|
| Hair Diameter | 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. |
Countries
China
Contacts
CONTACTJianglin Zhang
Outcome results
None listed