Androgenetic Alopecia, Androgenic Alopecia
Conditions
Keywords
Androgenic Alopecia, Janus Kinase 2, JAK2, minoxidil
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.
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.
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.
PROCEDUREScalp Punch Biopsy
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.
DIAGNOSTIC_TESTTissue JAK2 Protein Measurement by ELISA
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.
Sponsors
Kasr El Aini Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Baseline Difference in Tissue JAK2 Protein Levels Between Balding and Non-Balding Scalp | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Tissue JAK2 Protein Levels in Balding Scalp After 12 Weeks of Topical Minoxidil | 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. |
| Change in Trichoscopic Hair Parameters After 12 Weeks of Treatment | 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. |
| Correlation Between Change in Tissue JAK2 Levels and Clinical Response | 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. |
Countries
Egypt
Contacts
CONTACTHeba Ahmed
Outcome results
None listed