For an Investigator-led Hair Study Comparing Between Healthy and Hair Loss Volunteers

Beyond the Scalp: A Multi-Omic Microbiome Analysis in Androgenetic Alopecia Patients at Baseline and After Oral Minoxidil Treatment Versus Healthy Controls

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07716748

Enrollment

Registered

2026-07-21

Start date

2026-08-01

Completion date

2028-01-01

Last updated

2026-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hair Loss

Brief summary

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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

21 Years to 45 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
Norwoord-Hamiton scale hairloss severity	6 months	Scale from 1 (no hair loss) to 7 (severe hair loss)
Change in hair density	6 months	Change from baseline in hair density at the vertex, crown and occipital zones Unit: u/cm2
Metabolomic profiling of the stool	6 months	Change in concentration of metabolites in the stool of AGA vs healthy cohorts.
Gut and Scalp/Follicle Microbiome Signature Differences at Baseline	Baseline	Taxonomic and functional composition of the gut and scalp/hair follicle microbiome. Units: relative abundance
Change in proteomic profile	6 months	Change in protein expression levels in scalp swabs samples, and differences between AGA and healthy cohorts.
Change in Gene Expression Profiles (Transcriptomics)	6 months	Evaluation of differentially expressed genes via spatial transcriptomics and single-cell RNA sequencing (scRNA-seq) from scalp biopsy samples comparing AGA participants to healthy controls. Units: Log2 Fold Change (or "Normalized Gene Expression Counts")
Metabolomic profile in blood/plasma	6 months	Change in concentration of metabolites in blood/plasma
Proteomic profiling of the blood	6 months	Change in proteins concentration levels in blood/plasma
Change in hair diameter distribution	6 months	Change from baseline in hair shaft diameter. Unit: µm

Secondary

Measure	Time frame	Description
Eyebrow to hairline measurement	6 months	The distance from the eyebrow to the hairline is one indicator of the recession of hairline
Dandruff scoring	6 months	The dandruff score ranges from 0 (no dandruff state) to 5 (very important dandruff state) for both adherent and non-adherent dandruffs
Change in Subject-Reported Hair Density	6 months	Evaluation of the volunteer's perceived change in hair density since the start of the study (assessed via self-assessment questionnaire). Scale : improvements range from "worsened significantly" to "improved significantly"
Measurement of sebum levels	6 months	Measure sebum levels on the forehead and scalp
Gut Microbiome in Oral Minoxidil Treatment Response	6 months	Association between gut microbiome composition (metabolomics and metagenomics from stool and blood/plasma) and clinical response to oral minoxidil treatment.
Change in Follicular Units Distribution	6 months	Change from baseline in percentage of single, double, triple... follicular units.

Outcome results