Androgenetic AlopeciaNCT07563036
JAK2 Expression in Androgenetic Alopecia Before and After Topical Minoxidil
A study testing Topical Minoxidil 5% Solution, Scalp Punch Biopsy and Tissue JAK2 Protein Measurement by ELISA in people with Androgenetic Alopecia and Androgenic Alopecia, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Androgenetic Alopecia, Androgenic Alopecia
- What is being tested?
- Topical Minoxidil 5% Solution, Scalp Punch Biopsy and Tissue JAK2 Protein Measurement by ELISA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2026to 1 Jan 2027
- Phase
- Interventional
- 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 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Kasr El Aini Hospital
Cairo, Cairo Governorate, 11555
Heba Ahmed, Lecturer of Dermatology, +201016532351, drhebaahmedyt@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Androgenetic Alopecia, Androgenic Alopecia
- Being tested
- Topical Minoxidil 5% Solution, Scalp Punch Biopsy, Tissue JAK2 Protein Measurement by ELISA
- Keywords
- Androgenic Alopecia, Janus Kinase 2, JAK2, minoxidil
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Minoxidil 5% SolutionDrug
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.
Scalp Punch BiopsyProcedure or surgery
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 JAK2 Protein Measurement by ELISADiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Topical Minoxidil 5% Solution; Procedure: Scalp Punch Biopsy; Diagnostic Test: Tissue JAK2 Protein Measurement by ELISA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (3)
Change in Tissue JAK2 Protein Levels in Balding Scalp After 12 Weeks of Topical Minoxidil
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.
Measured: Baseline to Week 12
Change in Trichoscopic Hair Parameters After 12 Weeks of Treatment
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.
Measured: Baseline to Week 12
Correlation Between Change in Tissue JAK2 Levels and Clinical Response
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.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 Feb 2026
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, heba ahmed abdelgayed ibrahim, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07563036
- Sponsor's protocol ID
- MS-655-2025
- Status last verified
- Apr 2026
- First submitted
- 25 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Janus Kinase 2 Expression in Patients With Androgenic Alopecia and Its Modulation by Topical Minoxidil Therapy.
- ClinicalTrials.gov ID
- NCT07563036
- Acronym / sponsor ID
- MS-655-2025
- Conditions
- Androgenetic Alopecia, Androgenic Alopecia
- Keywords
- Androgenic Alopecia, Janus Kinase 2, JAK2, minoxidil
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Topical Minoxidil 5% With Scalp Biopsy and JAK2 Assessment | Experimental | Drug: Topical Minoxidil 5% Solution, Procedure: Scalp Punch Biopsy, Diagnostic Test: Tissue JAK2 Protein Measurement by ELISAParticipants 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical Minoxidil 5% SolutionTopical 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. | Drug | Topical Minoxidil 5% With Scalp Biopsy and JAK2 Assessment |
| Scalp Punch BiopsyThree 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. | Procedure or surgery | Topical Minoxidil 5% With Scalp Biopsy and JAK2 Assessment |
| Tissue JAK2 Protein Measurement by ELISATissue 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. | Diagnostic test | Topical Minoxidil 5% With Scalp Biopsy and JAK2 Assessment |
Primary outcome
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.
3 secondary outcomes
Change in Tissue JAK2 Protein Levels in Balding Scalp After 12 Weeks of Topical Minoxidil
Time frame: Baseline to Week 12
Change in Trichoscopic Hair Parameters After 12 Weeks of Treatment
Time frame: Baseline to Week 12
Correlation Between Change in Tissue JAK2 Levels and Clinical Response
Time frame: Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical Minoxidil 5% Solution, Scalp Punch Biopsy and Tissue JAK2 Protein Measurement by ELISA in people with Androgenetic Alopecia and Androgenic Alopecia, run by Kasr El Aini Hospital at 1 site in Egypt.
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 1 May 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 Egypt. 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 Heba Ahmed (+201016532351, heba.a.abdelgayed@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline Difference in Tissue JAK2 Protein Levels Between Balding and Non-Balding Scalp (time frame: Baseline). 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 1 May 2026.