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

NCT07716748 | Not Yet Recruiting

• 1 other identifier: 2024-3681
• Study Type: observational
• Target: 66
• Locations: 0 countries
• Sites: N/A

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

Conditions

Hair Loss

Outcome Measures

Primary Outcomes (9)

• Norwoord-Hamiton scale hairloss severity

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

  6 months

• Change in hair density

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

  6 months

• Metabolomic profiling of the stool

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

  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

  Baseline

• Change in proteomic profile

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

  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")

  6 months

• Metabolomic profile in blood/plasma

  Change in concentration of metabolites in blood/plasma

  6 months

• Proteomic profiling of the blood

  Change in proteins concentration levels in blood/plasma

  6 months

• Change in hair diameter distribution

  Change from baseline in hair shaft diameter. Unit: µm

  6 months

Secondary Outcomes (6)

• Eyebrow to hairline measurement

  6 months

• Dandruff scoring

  6 months

• Change in Subject-Reported Hair Density

  6 months

• Measurement of sebum levels

  6 months

• Gut Microbiome in Oral Minoxidil Treatment Response

  6 months

Study Arms (2)

Healthy

With no hair loss

AGA patients

With hairloss

Eligibility Criteria

• Age: 21 Years - 45 Years
• Gender Eligibility Details: Cisgender people
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Skin Centre: lead

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples Hair follicles Swabs Punch biopsy Stools

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 21, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR