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NCT Number: NCT07716748

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

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

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male volunteer from 21 to 45 years old
  • Volunteer with BMI between 18.5 to 30 kg/m2
  • Volunteer willing and able to fulfill the study requirements and schedule
  • Volunteer willing to give their stool sample, as well as swabs, follicles, and blood.
  • Volunteer informed about the study objectives and procedures, and able to understand them
  • Volunteer who has given written informed consent

Volunteers in the healthy control panel must satisfy the following criteria:

  • Volunteer in overall good health
  • 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:

  • Volunteer diagnosed with Androgenetic Alopecia grade III Vertex to V on the Hamilton-Norwood scale
  • 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
  • Volunteer eligible to undergo oral minoxidil treatment, with no contra-indication

Exclusion criteria

  • Volunteer with severe gastro-intestinal symptoms (including gluten and lactose intolerance)
  • Volunteer with auto-immune disease, diabetes; hyper or hypo-thyroidism ; chronic kidney failure
  • Volunteer with diagnosis of scalp-related disease such as folliculitis, lichen planopilaris, folliculitis decalvans, tinea capitis, head lice, or seborrheic dermatitis
  • Volunteer undergoing hypertension treatment
  • Volunteer who undertook any oral anti-hair loss pharmaceutical treatment in the past 3 months (e.g. Finasteride)
  • Volunteer who undertakes any hormone-disrupting drug
  • Volunteer who used topical minoxidil or other pharmaceutical-grade topical hair restorers in the past 3 months
  • Volunteer with a total dandruff score above 1 on the L'Oreal Dandruff scale.
  • Volunteer who used perms or hair dyes in the past 2 months
  • Volunteer who underwent scalp reduction or hair transplant procedures
  • Volunteer who declares to be deprived of freedom by administrative or legal decision
  • Volunteer who cannot be contacted by phone in case of emergency
  • Volunteer having currently participating in another clinical study
  • Volunteer who used antibiotics or antifungal medication (topical to scalp and systemic) in the past 4 weeks
  • Volunteer who used probiotics supplements in the past 4 weeks. (dietary probiotics such as yogurt, kefir, and kimchi are acceptable)
  • Volunteer who follows a non-conventional diet (e.g. vegan, ketogenic, strict intermittent fasting diets)

Non-inclusion Criteria:

  • Volunteer diagnosed with HIV, Hepatitis C, Hepatitis B
  • Volunteer with severe gastro-intestinal symptoms (including gluten and lactose intolerance)
  • Volunteer with auto-immune disease, diabetes; hyper or hypo-thyroidism ; chronic kidney failure
  • Volunteer with diagnosis of scalp-related disease such as folliculitis, lichen planopilaris, folliculitis decalvans, tinea capitis, head lice, or seborrheic dermatitis
  • Volunteer undergoing hypertension treatment
  • Volunteer who undertook any oral anti-hair loss pharmaceutical treatment in the past 3 months (e.g. Finasteride)
  • Volunteer who undertakes any hormone-disrupting drug
  • Volunteer who used topical minoxidil or other pharmaceutical-grade topical hair restorers in the past 3 months
  • Volunteer with a total dandruff score above 1 on the L'Oreal Dandruff scale.
  • Volunteer who used perms or hair dyes in the past 2 months
  • Volunteer who underwent scalp reduction or hair transplant procedures
  • Volunteer who declares to be deprived of freedom by administrative or legal decision
  • Volunteer who cannot be contacted by phone in case of emergency
  • Volunteer having currently participating in another clinical study
  • Volunteer who used antibiotics or antifungal medication (topical to scalp and systemic) in the past 4 weeks
  • Volunteer who used probiotics supplements in the past 4 weeks. (dietary probiotics such as yogurt, kefir, and kimchi are acceptable)
  • Volunteer who follows a non-conventional diet (e.g. vegan, ketogenic, strict intermittent fasting diets)
  • 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)

Treatment and study plan

Primary outcomes

  1. Norwoord-Hamiton scale hairloss severity

    Time frame: 6 months

    Scale from 1 (no hair loss) to 7 (severe hair loss)

  2. Change in hair density

    Time frame: 6 months

    Change from baseline in hair density at the vertex, crown and occipital zones Unit: u/cm2

  3. Metabolomic profiling of the stool

    Time frame: 6 months

    Change in concentration of metabolites in the stool of AGA vs healthy cohorts.

  4. Gut and Scalp/Follicle Microbiome Signature Differences at Baseline

    Time frame: Baseline

    Taxonomic and functional composition of the gut and scalp/hair follicle microbiome.

    Units: relative abundance

  5. Change in proteomic profile

    Time frame: 6 months

    Change in protein expression levels in scalp swabs samples, and differences between AGA and healthy cohorts.

  6. Change in Gene Expression Profiles (Transcriptomics)

    Time frame: 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")

  7. Metabolomic profile in blood/plasma

    Time frame: 6 months

    Change in concentration of metabolites in blood/plasma

  8. Proteomic profiling of the blood

    Time frame: 6 months

    Change in proteins concentration levels in blood/plasma

  9. Change in hair diameter distribution

    Time frame: 6 months

    Change from baseline in hair shaft diameter. Unit: µm

Secondary outcomes

  1. Eyebrow to hairline measurement

    Time frame: 6 months

    The distance from the eyebrow to the hairline is one indicator of the recession of hairline

  2. Dandruff scoring

    Time frame: 6 months

    The dandruff score ranges from 0 (no dandruff state) to 5 (very important dandruff state) for both adherent and non-adherent dandruffs

  3. Change in Subject-Reported Hair Density

    Time frame: 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"

  4. Measurement of sebum levels

    Time frame: 6 months

    Measure sebum levels on the forehead and scalp

  5. Gut Microbiome in Oral Minoxidil Treatment Response

    Time frame: 6 months

    Association between gut microbiome composition (metabolomics and metagenomics from stool and blood/plasma) and clinical response to oral minoxidil treatment.

  6. Change in Follicular Units Distribution

    Time frame: 6 months

    Change from baseline in percentage of single, double, triple... follicular units.

Sponsors and collaborators

Lead sponsor

National Skin Centre

Network

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 21, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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