Find Autosomal Recessive Hypotrichosis Clinical Trials Near You
Safety and Efficacy of Lactobacillus Reuteri for Androgenetic Alopecia: A Single-Center, Randomized, Double-Blind, Placebo-Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Shenzhen People's Hospital
RECRUITING
Shenzhen
Contact Information
Primary
Jianglin Zhang
zhang.jianglin@szgospital.com
+86 13873143466
Time Frame
Start Date:2026-01-25
Estimated Completion Date:2027-06
Participants
Target number of participants:388
Treatments
Experimental: Test Group
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.
Other: Inactivated Control Group
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.
Active_comparator: Positive Control Group
Commercially available 5% minoxidil tincture 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.
Placebo_comparator: Negative Control Group
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.