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Not yet recruiting NCT07716748

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

— Observational Hair Loss

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Hair Loss. Basic parameters: 21 years — 45 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Primary outcome measures

  • Norwoord-Hamiton scale hairloss severity [Time frame: 6 months]
  • Change in hair density [Time frame: 6 months]
  • Metabolomic profiling of the stool [Time frame: 6 months]
  • Gut and Scalp/Follicle Microbiome Signature Differences at Baseline [Time frame: Baseline]
  • Change in proteomic profile [Time frame: 6 months]
  • Change in Gene Expression Profiles (Transcriptomics) [Time frame: 6 months]
  • Metabolomic profile in blood/plasma [Time frame: 6 months]
  • Proteomic profiling of the blood [Time frame: 6 months]
  • Change in hair diameter distribution [Time frame: 6 months]
Secondary outcome measures (6)
  • Eyebrow to hairline measurement [Time frame: 6 months]
  • Dandruff scoring [Time frame: 6 months]
  • Change in Subject-Reported Hair Density [Time frame: 6 months]
  • Measurement of sebum levels [Time frame: 6 months]
  • Gut Microbiome in Oral Minoxidil Treatment Response [Time frame: 6 months]
  • Change in Follicular Units Distribution [Time frame: 6 months]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07716748 · 2024-3681

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗