- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07563036
JAK2 Expression in Androgenetic Alopecia Before and After Topical Minoxidil
April 25, 2026 updated by: heba ahmed abdelgayed ibrahim, Kasr El Aini Hospital
Assessment of Janus Kinase 2 Expression in Patients With Androgenic Alopecia and Its Modulation by Topical Minoxidil Therapy.
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.
Study Overview
Status
Recruiting
Conditions
Detailed Description
This study will recruit 25 adult patients aged 18 to 50 years with mild to moderate androgenetic alopecia attending the Dermatology outpatient clinic, Cairo University Hospital.
At baseline, participants will undergo clinical evaluation, standardized photography, and trichoscopic assessment.
Three 2 mm scalp punch biopsies will be obtained over the course of the study: one from the balding scalp area and one from the non-balding scalp area at baseline, and one from the balding area after 3 months of therapy.
Tissue JAK2 protein levels will be measured by ELISA.
Participants will receive topical minoxidil 5% solution for 3 months (1 cc twice daily for men and once daily for women).
The primary endpoint is the comparison of tissue JAK2 levels between balding and non-balding scalp at baseline.
Secondary analyses will assess change in JAK2 levels after treatment and correlations with clinical improvement by trichoscopy.
Study Type
Interventional
Enrollment (Estimated)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Heba Ahmed
- Phone Number: +201016532351
- Email: heba.a.abdelgayed@kasralainy.edu.eg
Study Locations
-
-
Cairo Governorate
-
Cairo, Cairo Governorate, Egypt, 11555
- Recruiting
- Kasr El Aini Hospital
-
Contact:
- Heba Ahmed, Lecturer of Dermatology
- Phone Number: +201016532351
- Email: drhebaahmedyt@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Topical Minoxidil 5% With Scalp Biopsy and JAK2 Assessment
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.
|
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.
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Baseline Difference in Tissue JAK2 Protein Levels Between Balding and Non-Balding Scalp
Time Frame: Baseline
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Tissue JAK2 Protein Levels in Balding Scalp After 12 Weeks of Topical Minoxidil
Time Frame: Baseline to Week 12
|
Change in tissue Janus Kinase 2 (JAK2) protein levels measured by ELISA in scalp biopsy specimens obtained from the balding scalp area at baseline and again after 12 weeks of topical minoxidil 5% treatment.
|
Baseline to Week 12
|
|
Change in Trichoscopic Hair Parameters After 12 Weeks of Treatment
Time Frame: Baseline to Week 12
|
Change in trichoscopic parameters from baseline to Week 12, including hair density, terminal hair density, vellus hair density, average hair thickness, follicular unit density, percentage of single, double, and triple-or-more hairs per follicular unit, and average number of hairs per follicular unit.
|
Baseline to Week 12
|
|
Correlation Between Change in Tissue JAK2 Levels and Clinical Response
Time Frame: Week 12
|
Correlation between the change in tissue JAK2 protein levels after treatment and the degree of clinical improvement assessed by trichoscopic parameters and baseline clinical characteristics.
|
Week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2026
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
January 1, 2027
Study Registration Dates
First Submitted
April 25, 2026
First Submitted That Met QC Criteria
April 25, 2026
First Posted (Actual)
May 1, 2026
Study Record Updates
Last Update Posted (Actual)
May 1, 2026
Last Update Submitted That Met QC Criteria
April 25, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MS-655-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
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
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Androgenetic Alopecia
-
Veradermics, Inc.RecruitingAndrogenetic Alopecia | AGA | Hair Loss | Female Androgenetic Alopecia | Androgenetic Alopecia (AGA)United States
-
Universitätsklinikum Hamburg-EppendorfRecruiting
-
National Institute of Blood and Marrow Transplant...Pak Emirates Military HospitalEnrolling by invitationAndrogenetic Alopecia | Androgenetic Alopecia (AGA)Pakistan
-
University of FloridaWithdrawnFemale Androgenetic AlopeciaUnited States
-
Assiut UniversityNot yet recruitingAndrogenetic Alopecia | Androgenetic Alopecia (AGA)Egypt
-
PDFE Pharma Innovations FZCOActive, not recruitingAlopecia, Androgenetic | Baldness | Androgenetic Alopecia (AGA)India
-
Shanghai Zhongshan HospitalRecruitingAndrogenetic Alopecia (AGA)China
-
Suzhou Kintor Pharmaceutical Inc,Suzhou Koshine Biomedica, Inc.Not yet recruitingAndrogenetic Alopecia (AGA)China
-
Suzhou Kintor Pharmaceutical Inc,Completed
-
Eurofarma Laboratorios S.A.Not yet recruitingAndrogenetic Alopecia | Androgenetic Alopecia (AGA)
Clinical Trials on Topical Minoxidil 5% Solution
-
Maja Kovacevic, MDWithdrawnAndrogenetic Alopecia | Female Pattern Hair LossItaly
-
PDFE Pharma Innovations FZCOActive, not recruitingAlopecia, Androgenetic | Baldness | Androgenetic Alopecia (AGA)India
-
Farid MasoudCompletedAndrogenetic AlopeciaIran, Islamic Republic of
-
Indonesia UniversityCompletedAndrogenetic AlopeciaIndonesia
-
Kasr El Aini HospitalRecruitingAndrogenic AlopeciaEgypt
-
Shanghai Zhongshan HospitalRecruitingAndrogenetic Alopecia (AGA)China
-
Triple Hair IncRecruiting
-
Indonesia UniversityActive, not recruitingAndrogenetic AlopeciaIndonesia
-
Applied Biology, Inc.CompletedAndrogenetic AlopeciaUnited States, Australia, India, Italy
-
Applied Biology, Inc.CompletedAlopecia | Female Pattern Hair LossUnited States, Australia, India, Italy