Assessment of Janus Kinase 2 Expression in Patients With Androgenic Alopecia and Its Modulation by Topical Minoxidil Therapy.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Baseline Difference in Tissue JAK2 Protein Levels Between Balding and Non-Balding Scalp
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Topical Minoxidil 5% Solution (Drug)
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.
干预措施: Scalp Punch Biopsy (Procedure)
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.
干预措施: Tissue JAK2 Protein Measurement by ELISA (Diagnostic Test)
结局指标
主要结局
Baseline Difference in Tissue JAK2 Protein Levels Between Balding and Non-Balding Scalp
时间窗: 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.
次要结局
- 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)
研究者
heba ahmed abdelgayed ibrahim
Lecturer of Dermatology
Kasr El Aini Hospital