A comparative randomised controlled trial evaluating the efficacy of topical tofacitinib versus topical clobetasol propionate in localised alopecia areata.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Hair regrowth score (RGS) at end of 4 months.
研究概览
简要总结
The study will be conducted amongst patients of localised alopecia areata attending Dermatology, Venereology and Leprology department, AIIMS Jodhpur. The study will be including patients who are clinically diagnosed with localised alopecia areata over scalp with SALT score S1(<25% hair loss) with age group >5 years, having stable disease without appearance of new patch or increase in size of existing patch in last 15 days and without evidence of spontaneous hair regrowth. Patients who are pregnant, lactating, who had received any topical in last 2 weeks or systemic corticosteroid, immunosuppressant or oral tofacitinib in past 4 weeks, Alopecia totalis, alopecia universalis, ophiasis, sisaipho and alopecia with sites other than scalp, history of HIV, Hepatitis C, Hepatitis B, Tuberculosis, hepatic and renal impairment will be excluded from the study. The research question is whether topical tofacitinib is better than topical clobetasol propionate in patients of alopecia areata in terms of efficacy. The aim of the study is to compare the efficacy of topical tofacitinib versus topical clobetasol propionate in localised alopecia areata. The primary objective is to compare the efficacy of topical tofacitinib versus topical clobetasol propionate in localised alopecia areata in terms of Hair Regrowth Score (RGS). The secondary objective is to compare the no. of patients having >50% improvement in RGS, % reduction in area involved with alopecia areata in both groups, quality of life of patients using DLQI, to compare the side effects profile in both the groups and to assess relapse (if any) in both the groups. Patients will be given topical tofacitinib 2% ointment twice daily and topical clobetasol propionate 0.05% ointment is given twice daily to patients with age group more than 12 years and in age group 6-12 years, clobetasol is given twice a day for 4 weeks then once a day for 4 weeks then on alternate days for 4 weeks and twice a week for 4 weeks. The total duration of treatment is 4 months. At every visit, expected outcome will be assessed by clinical picture, trichoscopy, RGS, SALT at baseline and every visit. The study duration will be approximately 18 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients who are clinically diagnosed with localized alopecia areata over scalp.
- •SALT score S1(less than 25 percent hair loss).
- •Age group more than 5 years.
- •Stable disease without appearance of new patch or increase in size of existing patch in last 15 days and without evidence of spontaneous hair regrowth.
排除标准
- •Pregnant and lactating females.
- •Patients who have received any topical treatment within the last 2 weeks or systemic corticosteroids, immunosuppressants, or oral tofacitinib in the past month.
- •Patch with atrophy or active infection at the site of patch.
- •Alopecia totalis, alopecia universalis, ophiasis, sisaipho pattern and alopecia areata involving sites other than scalp.
- •Patients with history of HIV, Hep B, Hep C, TB, leucopenia, hepatic and renal impairment.
结局指标
主要结局
Hair regrowth score (RGS) at end of 4 months.
时间窗: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks
次要结局
- 1.Number of patients having more than 50% improvement in RGS score.
研究者
Sukarna Saha
All India Institute of Medical Science, Jodhpur
