Beyond the Scalp: A Multi-Omic Microbiome Analysis in Androgenetic Alopecia Patients at Baseline and After Oral Minoxidil Treatment Versus Healthy Controls
| Registry | NCT07716748 |
|---|---|
| Status | Not yet recruiting |
| Study type | Observational |
| Enrollment | 66 (Estimated) |
| Sponsor | National Skin Centre (Network) |
| Conditions | Hair Loss |
| Dates | start 2026-08-01 (estimated), primary completion 2028-01-01 (estimated), completion 2028-01-01 (estimated), first posted 2026-07-21, last updated 2026-07-21 |
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All trials for Hair Loss
This study is to evaluate differences in the gut and follicle/scalp microbiome signature in AGA compared to a non-AGA population. Also, to investigate differences in inflammation and other biomarkers in AGA compared to non-AGA population at baseline and after a successful treatment
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Healthy | With no hair loss | ||
| AGA patients | With hairloss |
Sex: Male, ages: 21 Years to 45 Years, accepts healthy volunteers
Inclusion Criteria: 1. Male volunteer from 21 to 45 years old 2. Volunteer with BMI between 18.5 to 30 kg/m2 3. Volunteer willing and able to fulfill the study requirements and schedule 4. Volunteer willing to give their stool sample, as well as swabs, follicles, and blood. 5. Volunteer informed about the study objectives and procedures, and able to understand them 6. Volunteer who has given written informed consent Volunteers in the healthy control panel must satisfy the following criteria: 1. Volunteer in overall good health 2. Volunteer with no diagnosis of hair loss or other condition or treatment susceptible to impact hair count and microbiome. Volunteers in the AGA panel must satisfy the following criteria: 1. Volunteer diagnosed with Androgenetic Alopecia grade III Vertex to V on the Hamilton-Norwood scale 2. Volunteer willing to restrain from the use of any additional hair loss oral and topical pharmaceuticals (ex: topical minoxidil) over the course of the study 3. Volunteer eligible to undergo oral minoxidil treatment, with no contra-indication Exclusion Criteria: 1. Volunteer with severe gastro-intestinal symptoms (including gluten and lactose intolerance) 2. Volunteer with auto-immune disease, diabetes; hyper or hypo-thyroidism ; chronic kidney failure 3. Volunteer with diagnosis of scalp-related disease such as folliculitis, lichen planopilaris, folliculitis decalvans, tinea capitis, head lice, or seborrheic dermatitis 4. Volunteer undergoing hypertension treatment 5. Volunteer who undertook any oral anti-hair loss pharmaceutical treatment in the past 3 months (e.g. Finasteride) 6. Volunteer who undertakes any hormone-disrupting drug 7. Volunteer who used topical minoxidil or other pharmaceutical-grade topical hair restorers in the past 3 months 8. Volunteer with a total dandruff score above 1 on the L'Oreal Dandruff scale. 9. Volunteer who used perms or hair dyes in the past 2 months 10. Volunteer who underwent scalp reduction or hair transplant procedures 11. Volunteer who declares to be deprived of freedom by administrative or legal decision 12. Volunteer who cannot be contacted by phone in case of emergency 13. Volunteer having currently participating in another clinical study 14. Volunteer who used antibiotics or antifungal medication (topical to scalp and systemic) in the past 4 weeks 15. Volunteer who used probiotics supplements in the past 4 weeks. (dietary probiotics such as yogurt, kefir, and kimchi are acceptable) 16. Volunteer who follows a non-conventional diet (e.g. vegan, ketogenic, strict intermittent fasting diets) Non-inclusion Criteria: 1. Volunteer diagnosed with HIV, Hepatitis C, Hepatitis B 2. Volunteer with severe gastro-intestinal symptoms (including gluten and lactose intolerance) 3. Volunteer with auto-immune disease, diabetes; hyper or hypo-thyroidism ; chronic kidney failure 4. Volunteer with diagnosis of scalp-related disease such as folliculitis, lichen planopilaris, folliculitis decalvans, tinea capitis, head lice, or seborrheic dermatitis 5. Volunteer undergoing hypertension treatment 6. Volunteer who undertook any oral anti-hair loss pharmaceutical treatment in the past 3 months (e.g. Finasteride) 7. Volunteer who undertakes any hormone-disrupting drug 8. Volunteer who used topical minoxidil or other pharmaceutical-grade topical hair restorers in the past 3 months 9. Volunteer with a total dandruff score above 1 on the L'Oreal Dandruff scale. 10. Volunteer who used perms or hair dyes in the past 2 months 11. Volunteer who underwent scalp reduction or hair transplant procedures 12. Volunteer who declares to be deprived of freedom by administrative or legal decision 13. Volunteer who cannot be contacted by phone in case of emergency 14. Volunteer having currently participating in another clinical study 15. Volunteer who used antibiotics or antifungal medication (topical to scalp and systemic) in the past 4 weeks 16. Volunteer who used probiotics supplements in the past 4 weeks. (dietary probiotics such as yogurt, kefir, and kimchi are acceptable) 17. Volunteer who follows a non-conventional diet (e.g. vegan, ketogenic, strict intermittent fasting diets) 18. Volunteer who used anti-dandruff shampoo in the past 4 weeks (For example, commonly used brands for anti-dandruffs could be : Head \& Shoulders, Sebamed, Clear, Dove, Pantene, L'OREAL, Vichy Dercos)