Actively Recruiting
Safety and Efficacy of Lactobacillus Reuteri for Androgenetic Alopecia: A Single-Center, Randomized, Double-Blind, Placebo-Controlled Trial
Led by Shenzhen People's Hospital · Updated on 2026-04-01
388
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of applying Lactobacillus reuteri topically to treat androgenetic alopecia, a common form of hair loss. This randomized, double-blind, placebo-controlled trial aims to determine whether balancing the scalp's microbial community can support hair follicle function. The study compares the probiotic solution to inactivated probiotic, saline placebo, and 5% minoxidil over one year. Participants will be randomly assigned to one of four groups: active Lactobacillus reuteri powder dissolved in saline, inactivated Lactobacillus reuteri powder in saline, 5% minoxidil solution, or saline placebo. Each treatment is applied once daily to the scalp using cotton swabs after cleansing, with participants avoiding hair washing for at least 6 hours afterward. The treatment period lasts 12 months. During the study, participants will have follow-up visits at 1, 3, 6, and 12 months to assess hair density and hair thickness. Assessments include scalp evaluation and hair measurements. The trial monitors safety and treatment adherence throughout. The main outcome is the change in hair count per square centimeter after one year, with additional measures of hair quality to help understand the potential benefits of these treatments.
CONDITIONS
Brief Title
Topical Application of Lactobacillus Reuteri for Androgenetic Alopecia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of androgenetic alopecia at Norwood-Hamilton stage II-IV or Ludwig grade I-III confirmed by medical history, clinical presentation, and trichoscopy
- Aged 18 to 60 years and generally in good health
- No use of any hair loss medications within the past six months
- No alopecia areata, local infections, or neuromuscular disorders
- Voluntary participation with informed consent
You will not qualify if you...
- Androgenetic alopecia progression longer than 5 years
- Active skin diseases such as psoriasis flare
- Uncontrolled diabetes or cardiovascular disease
- Investigator-assessed inability to follow the study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants apply a topical solution once daily for 12 months. The solution varies by group and includes Lactobacillus reuteri, inactivated Lactobacillus reuteri, 5% minoxidil, or normal saline. Participants apply 1 mL to the scalp following cleansing and refrain from washing hair for at least 6 hours after application.
Follow-up visits at 1, 3, 6, and 12 months after treatment start
Trial Site Locations
Total: 1 location
1
Shenzhen People's Hospital
Shenzhen, Guangdong, China
Actively Recruiting
Research Team
J
Jianglin Zhang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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