Multi-Omics Insights Into Androgenetic Alopecia

NCT07603544 | Not Yet Recruiting

• 1 other identifier: AGA-XXMU-202602
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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). Our primary aim is to elucidate the key mechanisms driving hair follicle stem cell (HFSC) exhaustion and to identify potential therapeutic targets. We 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, we 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, we will establish an integrated clinical-omics-validation database, providing a robust theoretical foundation for the precision diagnosis and treatment of AGA.

Conditions

Androgenetic Alopecia (AGA)

Keywords

single-cell RNA sequencing; spatial transcriptomics

Outcome Measures

Primary Outcomes (3)

• Diagonse of AGA

  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

  at enrollment

• Quality control of the scalp tissues from AGA patients

  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.

  30 days

• Target screening based on single-cell sequencing and spatial transcriptomics data analysis

  By integrating spatial transcriptomic and single-cell expression landscapes, we 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

  About 150 days after all sample collected

Study Arms (4)

Young healthy controls

Subjects 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.

Other: Collection of ~2 × 12 mm scalp tissue; Other: Single-cell sequencing and spatial transcriptome sequencing

Young patients with AGA

Patients 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.

Other: Collection of ~2 × 12 mm scalp tissue; Other: Single-cell sequencing and spatial transcriptome sequencing

Aged healthy controls

Subjects 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.

Other: Collection of ~2 × 12 mm scalp tissue; Other: Single-cell sequencing and spatial transcriptome sequencing

Aged patients with AGA

Patients 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.

Other: Collection of ~2 × 12 mm scalp tissue; Other: Single-cell sequencing and spatial transcriptome sequencing

Interventions

Collection of ~2 × 12 mm scalp tissue OTHER

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.

Aged healthy controls; Aged patients with AGA; Young healthy controls; Young patients with AGA

Single-cell sequencing and spatial transcriptome sequencing OTHER

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).

Aged healthy controls; Aged patients with AGA; Young healthy controls; Young patients with AGA

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with AGA

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Xinxiang Medical College: lead

Study Sites (1)

The First Affiliated Hospiatl of Henan Medical University

Xinxiang, Henan, 453003, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

OCT-embedded tissue

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

Central Study Contacts

Wenjie Ren

CONTACT

8618937302619; 157121431@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 22, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

CN (1)