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临床试验/CTRI/2026/03/106939
CTRI/2026/03/106939尚未招募不适用

A COMPARATIVE STUDY ON THE THERAPEUTIC EFFICACY OF TOPICAL TOFACITINIB 2 PERCENT OINTMENT WITH EXCIMER LASER 308nm VERSUS TOPICAL TOFACITINIB 2 PERCENT OINTMENT MONOTHERAPY IN STABLE

ERAS LUCKNOW MEDICAL COLLEGE1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2026年4月6日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
52
试验地点
1
主要终点
To compare the efficacy of topical tofacitinib (2%) ointment combined with excimer laser (308nm) therapy, with topical tofacitinib (2%) ointment

研究概览

简要总结

A total of 52 patients with stable vitiligo fulfilling inclusion criteria will be

enrolled in our study.

Study design: Randomized comparative prospective study.

Place of study: Department of Dermatology, ERA’s Lucknow Medical College & Hospital, Lucknow, India.

Sample size: 52 patients (26 patients in each group)

Study period: 24 months

Method of sampling: Simple Random Sampling.

STUDY DESIGN: Randomized comparative prospective study.

Written informed consent will be taken from patients prior to participation inthe study.Patients will be randomly divided into two groups – A and B each containing 26 individuals.History and clinical examination with photographic documentation, VASI (Vitiligo Area Severity Index) score and subjective response before starting treatment and then at each visit (4, 8, 12 and 16 weeks).Follow-up visits at 4, 8, 12, 16, 20 and 24 weeks will be conducted and results will be tabulated in respective tables. In  one group  – Patient will be advised to apply topical tofacitinib (2%) ointment twice daily AND undergo excimer laser (308nm) therapy twice a week over the lesion for a duration of 12 weeks.

In another group  – Patient will be advised to apply topical tofacitinib (2%) ointment alone, twice daily over the lesion for a duration of 12 weeks.Patients will be assessed at baseline then followed up at 4, 8, 12 and 16

weeks and at each follow up visit clinical response will be determined by the reduction in VASI score and Subjective response. Based on the reduction in the VASI score and Subjective response the therapeutic efficacy is graded.

Assessment will be done at baseline , 0, 4 8 12, 16 weeks.

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 80.00 Year(s)(—)
性别
All

入选标准

  • Stable vitiligo patients aged between 18 and 80, of either gender with clinical diagnosis of stable vitiligo Involving less than 5% of body surface area, attending the Dermatology OPD at ELMC&H.

排除标准

  • Vitiligo patients who took treatment in last 3 months.
  • Patient having hypersensitivity to topical tofacitinib (2%) ointment.
  • History of photosensitivity disorders or contraindications to phototherapy.
  • History of intolerance to Excimer (308nm) light.
  • Pregnant and lactating women.

结局指标

主要结局

To compare the efficacy of topical tofacitinib (2%) ointment combined with excimer laser (308nm) therapy, with topical tofacitinib (2%) ointment

时间窗: 0,4,8,12,16 weeks

monotherapy, in achieving repigmentation in patients with stable vitiligo.

时间窗: 0,4,8,12,16 weeks

次要结局

  • To identify any adverse effects with use of topical tofacitinib (2%) ointment,(excimer laser (308nm) and their combination in stable vitiligo.)

研究者

发起方
ERAS LUCKNOW MEDICAL COLLEGE
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

SHREYA PODDAR

Eras Lucknow Medical College And Hospital

研究点 (1)

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