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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Group | Experimental | 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. |
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| Inactivated Control Group | Other | 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. |
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| Positive Control Group | Active Comparator | 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. |
|
| Negative Control Group | Placebo Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus reuteri | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hair Density | Hair density is quantified by counting all visible growing hairs in a unit area of the scalp using a trichoscope | The follow-up periods are set at 1, 3, 6, and 12 months after the initial treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Hair Diameter | Trichoscopy is used to measure the average hair shaft diameter (cross-sectional thickness) of all growing hairs in a defined scalp area. | The follow-up periods are set at 1, 3, 6, and 12 months after the initial treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianglin Zhang | Contact | +86 13873143466 | zhang.jianglin@szgospital.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenzhen People's Hospital | Recruiting | Shenzhen | Guangdong | China |
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| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D008914 | Minoxidil |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
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| Inactivated Lactobacillus reuteri | Biological | 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. |
|
| 5% Minoxidil | Drug | 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. |
|
| Normal Saline | Drug | 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. |
|
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |