AzTrials
AzTrials

Androgenetic Alopecia (AGA)NCT07603544

Multi-Omics Insights Into Androgenetic Alopecia

An observational study of Androgenetic Alopecia (AGA), run by The First Affiliated Hospital of Xinxiang Medical College at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study utilizes a multi-omics approach to systematically characterize the cellular heterogeneity and spatial architecture of the hair follicle microenvironment in patients with androgenetic alopecia (AGA). Read more about this study

Who is it for?
Ages 20 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for
Androgenetic Alopecia (AGA)
What is being tested?
Collection of ~2 × 12 mm scalp tissue and Single-cell sequencing and spatial transcriptome sequencing
Type of treatment
Injection or infusion
How many people
12 participants
Where
1 siteChina
Study dates
8 Mar 2026to Mar 2027
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 20 to 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: patients with AGA

Who may be able to join

  • Age and Gender: Males aged 25-30 or 60-65 years.
  • Diagnosis: Patient Group: Diagnosed by a physician with Hamilton-Norwood Stage III androgenetic alopecia (AGA). Healthy Control Group: Healthy scalp with no signs of hair loss.
  • Medication and Treatment History: No use of anti-hair loss medications (e.g., minoxidil, finasteride), hormonal drugs, or scalp chemical treatments (perm or dye) within the last 6 months.
  • Informed Consent: Voluntarily signed and provided written informed consent.

Who cannot join

  • Scalp Conditions: Presence of other types of alopecia (besides AGA) or active scalp diseases (e.g., psoriasis, dermatitis, infections).
  • Medical History: History of keloids or coagulation disorders.
  • Systemic Diseases: Major underlying conditions, including severe cardiovascular/cerebrovascular diseases, immune system disorders, or malignant tumors.
  • Allergies: Known hypersensitivity to local anesthetics.
  • Prior Clinical Trials: Participation in any other clinical trials within 3 months prior to screening.
  • Other Factors: Any other conditions deemed unsuitable for participation by the investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • The First Affiliated Hospiatl of Henan Medical University

    Xinxiang, Henan, 453003

    Recruiting

Other trials in China

About this study

Official title: Multi-Omics Analysis of the Hair Follicle Microenvironment in Androgenetic Alopecia for Mechanistic Study and Target Identification

This study utilizes a multi-omics approach to systematically characterize the cellular heterogeneity and spatial architecture of the hair follicle microenvironment in patients with androgenetic alopecia (AGA). Our primary aim is to elucidate the key mechanisms driving hair follicle stem cell (HFSC) exhaustion and to identify potential therapeutic targets. Investigators will collect six groups of scalp tissue samples, which include healthy controls and AGA patients (stratified into younger and older cohorts). By integrating spatial transcriptomics, single - cell sequencing data, investigators will map aberrant cell subpopulations and their complex interaction networks. Furthermore, the identified core targets will be functionally validated using patient-derived organoids and animal models. Expected outcomes include the identification of 3-5 critical cell subpopulations and the discovery of 8-10 disease-associated targets. Additionally, investigators will establish an integrated clinical-omics-validation database, providing a robust theoretical foundation for the precision diagnosis and treatment of AGA.

Read the detailed description

Data from the 2025 White Paper on China's Scalp Health Industry reveals that the hair-loss population in China has exceeded 340 million. Notably, the 20-to-35 age group accounts for nearly 70% of this demographic (a 23% increase compared to 2020). The post-90s and post-00s generations have become the primary consumers of anti-hair loss products, highlighting an increasingly prominent trend of hair loss occurring at a younger age and correlating with specific occupational profiles. Further demographic analysis indicates that finance and internet professionals enduring chronic high stress and late nights, postpartum women experiencing hormonal fluctuations, dieters with nutritional deficiencies, and individuals who frequently dye or perm their hair collectively constitute a massive and diverse market for anti-hair loss solutions. However, among the various types of hair loss, androgenetic alopecia (AGA), primarily driven by genetic factors, accounts for 80% of young outpatient cases. Epidemiological surveys indicate that the prevalence of AGA in China has reached 21.3% in males and 6% in females. The pathogenesis of AGA is highly complex, involving the interplay of multiple factors such as genetic susceptibility, abnormal androgen metabolism, cellular senescence, neuroendocrine dysregulation, and immune microenvironment imbalances; its precise molecular regulatory networks have yet to be fully elucidated.

In recent years, the rapid advancement of single-cell RNA sequencing (scRNA-seq) and spatial transcriptomics has made them cutting-edge tools for characterizing the hair follicle microenvironment and cellular heterogeneity. In the field of hair aging (graying), research has predominantly focused on the single-cell level. For instance, the first human gray hair single-cell atlas constructed by Wu et al. revealed the synergistic exhaustion mechanism of melanocyte stem cells (McSCs) and matrix hair progenitors. Furthermore, the release of noradrenaline by sympathetic nerves under acute stress, or DNA damage-induced McSC "seno-differentiation" and autoimmune responses, have all been proven to be key drivers leading to the depletion of the stem cell pool.

In exploring the mechanisms of hair loss diseases, the research horizon has further expanded from single-cell analysis to "spatial multi-omics." Spatial omics has demonstrated significant advantages, particularly for hair loss types accompanied by immune infiltration. For example, in scarring alopecia (lichen planopilaris, LPP), the combined application of scRNA-seq and spatial transcriptomics precisely mapped the abnormal accumulation of CD8+ T cells and macrophages in the hair follicle bulge region, elucidating the spatial mechanisms by which IFN-γ and oncostatin M (OSM) drive follicular fibrosis. In alopecia areata (AA), spatial omics revealed that the loss of regulatory T cells around hair follicles is the core cause of immune privilege collapse. Regarding AGA, the primary focus of this study, previous researchers have utilized spatial technologies to preliminarily characterize the fibrotic microenvironment in balding areas and, combined with mouse models, explored the molecular mechanisms by which exosomes promote hair follicle regeneration.

In summary, integrating single-cell resolution with spatial positional information to deeply investigate hair loss mechanisms has become a mainstream trend in this field. Building upon this, the present study proposes a combined application of scRNA-seq and spatial transcriptomics to systematically compare the differences in cellular heterogeneity and spatial architecture of the hair follicle microenvironment between healthy individuals and AGA patients. This study aims to pinpoint the key cell subpopulations and their spatial interaction networks driving hair follicle stem cell (HFSC) exhaustion, comprehensively elucidate the core molecular mechanisms leading to HFSC functional decline, and identify potential therapeutic targets. Ultimately, this will provide a solid theoretical foundation and robust data support for the precision diagnosis and targeted intervention of AGA.

Being tested
Collection of ~2 × 12 mm scalp tissue, Single-cell sequencing and spatial transcriptome sequencing
Keywords
single-cell RNA sequencing, spatial transcriptomics
Medical subject headings
Alopecia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Collection of ~2 × 12 mm scalp tissueOther

    In the AGA group, scalp tissue samples were concurrently harvested from the affected balding area (vertex, Hamilton-Norwood III vertex) and an unaffected non-balding area (the central occipital region along the interauricular line). In healthy controls, scalp tissue was harvested solely from the occipital region.

  • Single-cell sequencing and spatial transcriptome sequencingOther

    Spatial Transcriptomics Sequencing Samples were embedded in OCT, cryosectioned (10 μm), fixed with methanol, and subjected to H\&E staining. After permeabilization (14 min) and RNA capture, libraries were constructed and sequenced on the Xenium platform (sequencing depth ≥ 5 million reads per sample).

    Single-Cell Sequencing Samples were minced and enzymatically digested using Collagenase IV, Dispase II, and DNAse I, followed by erythrocyte lysis, filtering, and resuspension. Single-cell suspensions were prepared with a cell viability ≥ 90% and a clump rate < 5%. Sequencing was performed on the 10x Genomics platform (sequencing depth ≥ 10,000 reads per cell).

Study groups in NCT07603544
Study groupRoleWhat they receive
Young healthy controlsSubjects included individuals aged 25 to 35 years classified as Hamilton-Norwood Class I, who had no family history of alopecia, no comorbid scalp disorders, and no exposure to anti-alopecia therapies, hormonal treatments, or chemical hair processing within the preceding 6 months.
Receives: Other: Collection of ~2 × 12 mm scalp tissue; Other: Single-cell sequencing and spatial transcriptome sequencing
Young patients with AGAPatients included individuals aged 25 to 35 years with a confirmed diagnosis of Hamilton-Norwood Grade III, who were free of other forms of alopecia or concurrent scalp disorders, and had no exposure to relevant pharmacological treatments or chemical hair processing within the preceding 6 months.
Receives: Other: Collection of ~2 × 12 mm scalp tissue; Other: Single-cell sequencing and spatial transcriptome sequencing
Aged healthy controlsSubjects included individuals aged older than 60 years classified as Hamilton-Norwood Class I, who had no family history of alopecia, no concurrent scalp disorders, and no exposure to anti-alopecia therapies, hormonal treatments, or chemical hair processing within the preceding 6 months.
Receives: Other: Collection of ~2 × 12 mm scalp tissue; Other: Single-cell sequencing and spatial transcriptome sequencing
Aged patients with AGAPatients included individuals aged older than 60 years with a confirmed diagnosis of Hamilton-Norwood Grade III, who were free of other forms of alopecia or concurrent scalp disorders, and had no exposure to relevant pharmacological treatments or chemical hair processing within the preceding 6 months.
Receives: Other: Collection of ~2 × 12 mm scalp tissue; Other: Single-cell sequencing and spatial transcriptome sequencing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with type III vertex androgenetic aopecia (AGA) as assessed by the Hamilton-Norwood classification

    Visually evaluated according to the Hamilton-Norwood classification, the presentation is consistent with Type III Vertex, manifesting as pronounced hair thinning or circumscribed alopecia at the vertex, alongside frontotemporal recession that does not surpass a standard Type III

    Measured: at enrollment

  2. Cell viability percentage and RNA integrity number (RIN) / DV200 scores of scalp tissue samples

    For single-cell RNA sequencing (scRNA-seq) sample quality control (QC), cell suspensions must demonstrate ≥80% viability, <5% clumping, optimal concentrations of 700-1,200 cells/µL, cell sizes <40 µm, and a debris-free background. For spatial transcriptomics QC, samples require an RNA Integrity Number (RIN) ≥7.0 for fresh frozen (FF) tissues or DV200 ≥50% for formalin-fixed paraffin-embedded (FFPE) tissues; furthermore, tissue sections (typically 10 µm for FF and 5 µm for FFPE) must be perfectly flat, free of folds, tears, or ice crystal artifacts, and fit strictly within the designated capture area of the chip.

    Measured: 30 days

  3. Number of candidate biomarkers identified for the molecular diagnosis of hair loss

    By integrating spatial transcriptomic and single-cell expression landscapes, investigators aim to construct a comprehensive 'clinical sample-omics data-target validation' relational database, thereby identifying 2-3 candidate biomarkers for the molecular diagnosis of hair loss

    Measured: About 150 days after all sample collected

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2026
  2. Study start8 Mar 2026
  3. Primary completionDec 2026 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

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
Cross-sectional
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07603544
Sponsor's protocol ID
AGA-XXMU-202602
Status last verified
Jun 2026
First submitted
27 Apr 2026
Last updated
15 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Androgenetic Alopecia (AGA), run by The First Affiliated Hospital of Xinxiang Medical College at 1 site in China.

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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Contact Wenjie Ren (8618937302619, 157121431@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with type III vertex androgenetic aopecia (AGA) as assessed by the Hamilton-Norwood classification (time frame: at enrollment). The study lists 3 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 15 Jun 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in