Hair LossNCT07716748
For an Investigator-led Hair Study Comparing Between Healthy and Hair Loss Volunteers
An observational study of Hair Loss, run by National Skin Centre.
Trial 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 Read more about this study
- Who is it for?
- Ages 21 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hair Loss
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: AGA volunteers will be referred by clinicians from National Skin Centre Healthy volunteers will be recruited by recruitment posters at National Skin Centre
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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)
About this study
Official title: Beyond the Scalp: A Multi-Omic Microbiome Analysis in Androgenetic Alopecia Patients at Baseline and After Oral Minoxidil Treatment Versus Healthy Controls
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
- Conditions
- Hair Loss
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy | With no hair loss | |
| AGA patients | With hairloss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Norwoord-Hamiton scale hairloss severity
Scale from 1 (no hair loss) to 7 (severe hair loss)
Measured: 6 months
Change in hair density
Change from baseline in hair density at the vertex, crown and occipital zones Unit: u/cm2
Measured: 6 months
Metabolomic profiling of the stool
Change in concentration of metabolites in the stool of AGA vs healthy cohorts.
Measured: 6 months
Gut and Scalp/Follicle Microbiome Signature Differences at Baseline
Taxonomic and functional composition of the gut and scalp/hair follicle microbiome.
Units: relative abundance
Measured: Baseline
Change in proteomic profile
Change in protein expression levels in scalp swabs samples, and differences between AGA and healthy cohorts.
Measured: 6 months
Change in Gene Expression Profiles (Transcriptomics)
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")
Measured: 6 months
Metabolomic profile in blood/plasma
Change in concentration of metabolites in blood/plasma
Measured: 6 months
Proteomic profiling of the blood
Change in proteins concentration levels in blood/plasma
Measured: 6 months
Change in hair diameter distribution
Change from baseline in hair shaft diameter. Unit: µm
Measured: 6 months
Secondary outcomes (6)
Eyebrow to hairline measurement
The distance from the eyebrow to the hairline is one indicator of the recession of hairline
Measured: 6 months
Dandruff scoring
The dandruff score ranges from 0 (no dandruff state) to 5 (very important dandruff state) for both adherent and non-adherent dandruffs
Measured: 6 months
Change in Subject-Reported Hair Density
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"
Measured: 6 months
Measurement of sebum levels
Measure sebum levels on the forehead and scalp
Measured: 6 months
Gut Microbiome in Oral Minoxidil Treatment Response
Association between gut microbiome composition (metabolomics and metagenomics from stool and blood/plasma) and clinical response to oral minoxidil treatment.
Measured: 6 months
Change in Follicular Units Distribution
Change from baseline in percentage of single, double, triple... follicular units.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hair LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Skin Centre
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07716748
- Sponsor's protocol ID
- 2024-3681
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Non-identifiable data will be shared with funding/research partners.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beyond the Scalp: A Multi-Omic Microbiome Analysis in Androgenetic Alopecia Patients at Baseline and After Oral Minoxidil Treatment Versus Healthy Controls
- ClinicalTrials.gov ID
- NCT07716748
- Acronym / sponsor ID
- 2024-3681
- Conditions
- Hair Loss
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- National Skin CentreResearch network
- Study start
- Aug 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | –With no hair loss |
| AGA patients | – | –With hairloss |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- AGA volunteers will be referred by clinicians from National Skin Centre Healthy volunteers will be recruited by recruitment posters at National Skin Centre
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (35 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Norwoord-Hamiton scale hairloss severity
Time frame: 6 months
Scale from 1 (no hair loss) to 7 (severe hair loss)
Change in hair density
Time frame: 6 months
Change from baseline in hair density at the vertex, crown and occipital zones Unit: u/cm2
Metabolomic profiling of the stool
Time frame: 6 months
Change in concentration of metabolites in the stool of AGA vs healthy cohorts.
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
Change in proteomic profile
Time frame: 6 months
Change in protein expression levels in scalp swabs samples, and differences between AGA and healthy cohorts.
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")
Metabolomic profile in blood/plasma
Time frame: 6 months
Change in concentration of metabolites in blood/plasma
Proteomic profiling of the blood
Time frame: 6 months
Change in proteins concentration levels in blood/plasma
Change in hair diameter distribution
Time frame: 6 months
Change from baseline in hair shaft diameter. Unit: µm
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: Yes. Non-identifiable data will be shared with funding/research partners.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hair Loss, run by National Skin Centre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Norwoord-Hamiton scale hairloss severity (time frame: 6 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.