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临床试验/CTRI/2025/06/089419
CTRI/2025/06/089419尚未招募不适用

Efficacy of intralesional steroids versus 2 percent tofacitinib ointment for treatment of patchy alopecia areata among patients attending dermatology clinic in a teaching tertiary care hospital: A randomized control trial

Dr Manobalan1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年4月7日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
change in severity of alopecia areata tool (SALT) score from baseline to week 12.

研究概览

简要总结

Alopeciaareata is a chronic, non-scarring, auto-immune condition affecting the hair bulb thereby resulting in hair loss. The life-time riskof AA is about 2.1% in both children and adults. It can present as single, welldemarcated patch of hair losss, multiple patches or extensive hair loss(alopecia totalis and alopecia universalis). Treatment response in high inpatchy type than extensive type. For patchy type intralesional corticosteroidremains the main stay of treatment with complete regrowth of hair. Newertreatment with JAK-STAT inhibitors is becoming a trend with unpredictableresults. Though there are literature for interalesional steroids in alopeciaareata, only paucity of studies in topical tofacitinib for alopecia areata. Inour study we will compare the outcomes of intralesional steroids and topicaltofacitinib in cases of patch type alopecia areata.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Double Blind Double Dummy

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Adult patients presenting with patch type alopecia areata involving scalp or face.
  • 2.No prior treatment with corticosteroids, JAK inhibitors, or immunosuppressive agents within the last six months.

排除标准

  • 1.Patients below 18 years of age.
  • 2.Extensive alopecia areata (sisaipho, ophiasis, reticular, alopecia sub-totalis, alopecia totalis, alopecia universalis) 3.Scarring alopecia 4.Patients with a known allergy to corticosteroids or tofacitinib.
  • 5.Pregnant or lactating women.

结局指标

主要结局

change in severity of alopecia areata tool (SALT) score from baseline to week 12.

时间窗: baseline to week 12

次要结局

  • trichoscopic parameters, such as number of yellow dots, black dots ana vellus hair measured from baseline to week 12.(adverse events including local reactions, skin atrophy, erythema, any systemic side effects.)

研究者

发起方
Dr Manobalan
申办方类型
Private medical college

研究点 (1)

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