Safety and Efficacy of Lactobacillus Reuteri for Androgenetic Alopecia: A Single-Center, Randomized, Double-Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 388
- 试验地点
- 1
- 主要终点
- Hair Density
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •AGA progression >5 years;
- •Active skin disease (e.g., psoriasis flare) or uncontrolled diabetes/CVD;
- •Investigator-assessed protocol non-feasibility.
研究组 & 干预措施
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.
干预措施: Lactobacillus reuteri (Biological)
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.
干预措施: Inactivated Lactobacillus reuteri (Biological)
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.
干预措施: 5% Minoxidil (Drug)
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.
干预措施: Normal Saline (Drug)
结局指标
主要结局
Hair Density
时间窗: 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
次要结局
- Hair Diameter(The follow-up periods are set at 1, 3, 6, and 12 months after the initial treatment)