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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical Minoxidil 5% Solution | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Heba Ahmed | Contact | +201016532351 | heba.a.abdelgayed@kasralainy.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasr El Aini Hospital | Recruiting | Cairo | Cairo Governorate | 11555 | Egypt |
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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| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D008914 | Minoxidil |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
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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.
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| Scalp Punch Biopsy | Procedure | 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 ELISA | Diagnostic 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. |
|
| 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. |
| 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. | Week 12 |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004364 |
| Pharmaceutical Preparations |