Efficacy and Safety of Oral Tofacitinib in the Treatment of Alopecia Areata
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- 50% reduction in Severity of Alopecia Tool (SALT)
研究概览
简要总结
This clinical trial was conducted at the Dermatology department of Services hospital Lahore. Patients of extensive and treatment resistant Alopecia areata were enrolled after ethical approval and informed consent by non-probability consecutive sampling. Inclusion criteria: Treatment with oral tofacitinib citrate was initiated at 5 mg twice daily for six months. Scalp hair loss was calculated at 4, 12 and 24 weeks using the validated Severity of Alopecia Tool (SALT) score, which ranges from 0% to 100%. Regrowth rate: (initial SALT score - final SALT score)/(initial SALT score) × 100 was noted. Response time (time from initiation of treatment to any sign of hair regrowth) was noted. DLQI of patients before and after treatment were noted. Side effects were noted. Pre- and post-treatment photographs were taken. Patients were followed up for another 6 months to look for relapse.
Data were entered and analyzed using SPSS 20. Means were calculated for quantitative variables, frequencies for qualitative data. Data were stratified for the role of effect modifiers.
详细描述
This clinical trial was conducted at the Dermatology department of Services hospital Lahore. Patients of extensive and treatment resistant Alopecia areata were enrolled after ethical approval and informed consent by non-probability consecutive sampling. Treatment with oral tofacitinib citrate was initiated at 5 mg twice daily for six months after labs and ruling out contraindications. Scalp hair loss was calculated at 4, 12 and 24 weeks using the validated Severity of Alopecia Tool (SALT) score, which ranges from 0% to 100%. Regrowth rate: (initial SALT score - final SALT score)/(initial SALT score) × 100 was noted. Response time (time from initiation of treatment to any sign of hair regrowth) was noted. DLQI of patients before and after treatment were noted. Side effects were noted. Pre- and post-treatment photographs were taken. Patients were followed up for another 6 months to look for relapse.
Data were entered and analyzed using SPSS 20. Means were calculated for quantitative variables, frequencies for qualitative data. Data were stratified for the role of effect modifiers.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Either gender Age 18 to 60 years Extensive disease (SALT > 24)
排除标准
- •Patients taking immunosuppressants or DMARDs Recent live vaccination Active or latent TB, Hepatitis B or C, HIV Malignancy Hypersensitivity to the drug Pregnant or lactating mothers
研究组 & 干预措施
Patients of Extensive alopecia areata
Patients of either gender, age between 18-60 years, having extensive alopecia areata (SALT>24)
干预措施: Oral Tofacitinib citrate (Drug)
结局指标
主要结局
50% reduction in Severity of Alopecia Tool (SALT)
时间窗: within 24 weeks
atleast 50% reduction of SALT score from baseline (pre-treatment)
50% reduction in Dermatology Life Quality Index (DLQI)
时间窗: within 24 weeks
Atleast 50% improvement in quality of life of patients by reduction in DLQI from baseline (pre-treatment)
次要结局
未报告次要终点
研究者
Hira Tariq
Principal Investigator
Services Institute of Medical Sciences, Pakistan