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临床试验/CTRI/2024/01/061673
CTRI/2024/01/061673尚未招募4 期

Comparative study on the therapeutic efficacy of topical bimatoprost (0.03%) ophthalmic solution and tacrolimus (0.1%) ointment in stable vitiligo.

Eras Lucknow Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年1月24日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
To compare the therapeutic response of topical bimatoprost (0.03%) ophthalmic solution with tacrolimus (0.1%) ointment in cases of stable vitiligo.

研究概览

简要总结

A total of 50 patients presenting to the Department of Dermatology, Eras Lucknow Medical College and Hospital, Lucknow of stable vitiligo i.e. Lack of progression of old lesions within the past 6 months and No new lesions developing within the same period will be approached for participation in the study. Patients meeting the inclusion and exclusion criteria and giving written consent for participating in the study shall be recruited. History and clinical examination with photographic documentation, and VASI (Vitiligo Area Severity Index) score will be done before starting treatment and then at each visit. Patients will be randomly divided into two groups – A and B each containing 25 individuals. In group A – Patients will be advised to apply Bimatoprost (0.03%) ophthalmic solution twice daily over the lesion for 12 weeks. In group B – Patients will be advised to apply tacrolimus (0.1%) ointment twice daily over the lesion for 12 weeks. Patients will be followed up at 4, 8, and 12 weeks and at each follow-up visit clinical response will be determined by the reduction in subjective response and VASI score. Based on the reduction in the subjective responseand VASI score the therapeutic efficacy is graded.

If at any point, any patient withdraws the consent or started developing new lesions during the study or does not come for 2 consecutive follow-ups despite telephonic reminder. He/She shall be considered dropped out of the study.

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 involving less than 5 % of body surface area attending the dermatology OPD at Era Lucknow Medical College and Hospital.

排除标准

  • Vitiligo patients who took treatment in last 3 months
  • Patient having hypersensitivity to tacrolimus ointment and bimatoprost ophthalmic solution.
  • Pregnant and lactating women.

结局指标

主要结局

To compare the therapeutic response of topical bimatoprost (0.03%) ophthalmic solution with tacrolimus (0.1%) ointment in cases of stable vitiligo.

时间窗: 0,4,8,12 weeks

次要结局

  • 1.To study the clinical response of bimatoprost (0.03%) ophthalmic solution on stable vitiligo.(2.To study the clinical response of tacrolimus (0.1%) ointment on stable vitiligo.)

研究者

发起方
Eras Lucknow Medical College and Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Riya

Eras Lucknow Medical College and Hospital

研究点 (1)

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