NCT07563036

Brief Summary

Androgenetic alopecia is a common form of progressive hair loss. This prospective single-arm pre-post interventional study aims to assess tissue Janus Kinase 2 (JAK2) expression in patients with androgenetic alopecia by comparing balding and non-balding scalp at baseline, and to evaluate changes in JAK2 expression in balding scalp after 3 months of topical minoxidil 5% therapy. Clinical response will be assessed using standardized trichoscopic parameters.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress29%
Feb 2026Jan 2027

Study Start

First participant enrolled

February 1, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 1, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

8 months

First QC Date

April 25, 2026

Last Update Submit

April 25, 2026

Conditions

Keywords

Androgenic AlopeciaJanus Kinase 2JAK2minoxidil

Outcome Measures

Primary Outcomes (1)

  • Baseline Difference in Tissue JAK2 Protein Levels Between Balding and Non-Balding Scalp

    Comparison of tissue Janus Kinase 2 (JAK2) protein levels measured by ELISA in scalp biopsy specimens obtained at baseline from the balding area (vertex) and the non-balding area (occipital scalp) of participants with androgenetic alopecia.

    Baseline

Secondary Outcomes (3)

  • Change in Tissue JAK2 Protein Levels in Balding Scalp After 12 Weeks of Topical Minoxidil

    Baseline to Week 12

  • Change in Trichoscopic Hair Parameters After 12 Weeks of Treatment

    Baseline to Week 12

  • Correlation Between Change in Tissue JAK2 Levels and Clinical Response

    Week 12

Study Arms (1)

Topical Minoxidil 5% With Scalp Biopsy and JAK2 Assessment

EXPERIMENTAL

Participants with androgenetic alopecia will undergo baseline clinical and trichoscopic assessment, baseline 2 mm punch scalp biopsies from balding and non-balding areas for tissue JAK2 protein measurement by ELISA, treatment with topical minoxidil 5% for 12 weeks, and a repeat 2 mm punch biopsy from the balding scalp after treatment for repeat JAK2 assessment.

Drug: Topical Minoxidil 5% SolutionProcedure: Scalp Punch BiopsyDiagnostic Test: Tissue JAK2 Protein Measurement by ELISA

Interventions

Topical minoxidil 5% solution applied to the affected scalp areas for 12 weeks. Men will apply 1 cc twice daily and women will apply 1 cc once daily.

Topical Minoxidil 5% With Scalp Biopsy and JAK2 Assessment

Three 2 mm punch biopsies will be obtained during the study: one from the balding scalp area and one from the non-balding scalp area at baseline, and one from the balding scalp area after 12 weeks of treatment.

Topical Minoxidil 5% With Scalp Biopsy and JAK2 Assessment

Tissue samples obtained from scalp punch biopsies will be analyzed for Janus Kinase 2 (JAK2) protein levels using ELISA at baseline and after 12 weeks of treatment.

Topical Minoxidil 5% With Scalp Biopsy and JAK2 Assessment

Eligibility Criteria

Age18 Years - 50 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male adults aged 18 to 50 years with androgenetic alopecia.
  • Mild to moderate disease severity, defined as Hamilton-Norwood scale II to V.
  • Patients who are treatment-naive or willing to undergo an adequate washout period for prior hair loss therapies of at least 1 month.
  • Willing and able to provide written informed consent.

You may not qualify if:

  • Other types of hair loss, including inflammatory or scarring alopecia.
  • Inflammatory scalp dermatoses, such as psoriasis or seborrheic dermatitis.
  • Use of systemic immunosuppressants, JAK inhibitors, or systemic corticosteroids within the last 12 months.
  • History of severe systemic disease, including renal, cardiovascular, or hepatic disease.
  • Chemotherapy during the last 5 years.
  • Bleeding disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr El Aini Hospital

Cairo, Cairo Governorate, 11555, Egypt

RECRUITING

MeSH Terms

Conditions

Alopecia

Interventions

MinoxidilSolutions

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinesPharmaceutical Preparations

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single-arm pre-post interventional study in which all participants with androgenetic alopecia receive topical minoxidil 5% for 12 weeks. Baseline assessments include comparison of balding and non-balding scalp tissue JAK2 expression, followed by reassessment of JAK2 expression in balding scalp after treatment.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Dermatology

Study Record Dates

First Submitted

April 25, 2026

First Posted

May 1, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared because this is a single-center study with a small sample size, and de-identification cannot be fully guaranteed. Aggregate results, including summary statistics and outcome analyses, will be made available through publication

Locations