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临床试验/CTRI/2025/03/082382
CTRI/2025/03/082382招募中3 期

A Hospital-based, Randomized Controlled Trial Comparing the Efficacy of topical 2 percent Tofacitinib ointment combined with microneedling versus topical percent ointment alone in treatment of Alopecia Areata

Dr Rohit Singh Chauhan1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2025年3月18日最近更新:

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
74
试验地点
1
主要终点
Percentage improvement in the Severity of the alopecia tool score in both groups

研究概览

简要总结

This study is devised to compare the efficacy of topical 2% tofacitinib ointment combined with microneedling versus topical 2% tofacitinib alone in patients of alopecia areata over a 24-week treatment period. This study recruits a total of 74 patients willing to participate in the study after taking informed consent and divides into two groups each having a total number of 37 participants randomly. One group will be receiving topical 2% tofacitinib ointment twice daily to be applied over the alopecia patches on scalp combined with microneedling (using 1.5 mm dermaroller) to be done at every 4 weekly interval on alopecia patches for 24 weeks. While, other other group will only receive topical 2% tofacitinib ointment twice daily to be applied over the alopecia patches on scalp for 24 weeks. Each participants will be followed up regularly at 4 weekly interval  for clinical assessment which will be recorded and to note any adverse effect if any to given therapy. At the end of 24 week outcomes will be compared in terms of percentage improvement in SALT score (severity of alopecia tool), trichoscopic findings(changes in scalp hair density, black dots, white dots, exclamation mark hairs), global photographic assessment and hair pull test in each group. Randomization will be done on the basis of computer generated randomization table with allocation concealment in opaque envelopes into above mentioned two groups.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Patients between the age group of 18 to 50 yrs Diagnosed with alopecia aerate exhibiting at least two patches of alopecia involving the scalp No history of treatment with microneedling or within 1 month before enrollment in study Willingness to adhere to the study protocol and attend follow-up visits.

排除标准

  • Active scalp infections or skin diseases systemic immunosuppressive or steroid therapy Known hypersensitivity to tofacitinib or any other study components Prior hair transplantation Any coagulation disorder or thrombocytopenia Patients having alopecia totalis and universalis history of cancer or hepatitis B or C, tuberculin test or IGRA test and HIV virus positive patients pregnant women and children more than 18 years of deranged biochemical profile.

结局指标

主要结局

Percentage improvement in the Severity of the alopecia tool score in both groups

时间窗: 0, 24 weeks, 48 weeks

次要结局

  • Trichoscopic findings ( terminal hairs, white dots, black dots, exclaimation mark sign)(0, 6th, 12th month)
  • 2. Global photographic assessment at baseline, 6th month and 12th month and comparision between them(o, 6th, 12th month)
  • 3. Hair pull test and assessment at baseline, 6th month and 12th month and comparision between them(0, 6th, 12th month)

研究者

发起方
Dr Rohit Singh Chauhan
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Rohit Singh Chauhan

All India Institute of Medical Sciences, Gorakhpur

研究点 (1)

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