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临床试验/CTRI/2024/02/062184
CTRI/2024/02/062184尚未招募4 期

Comparative efficacy of mycophenolate mofetil and clobetasol propionate for the treatment of oral erosive lichen planus

Dr L Krishna Prasad1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年2月6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
20
试验地点
1
主要终点
1.Efficacy of 2% topical mycophenolate mofetil ointment

研究概览

简要总结

20 subjects, referred to the Department of Oral Medicine will be evaluated by the investigator based on modified WHO criteria for erosive oral lichen planus (OLP)diagnosis (Van der Meij & Van der Waal, 2003), will be included. 10 patients with bilateral OLP receiving mycophenolate mofetil will be included in Group A and 10 patients with OLP receiving clobetasol will be included in (Group B).In Group A, the patients will be instructed to place 2% Mycophenolate mofetil (MMF) mucoadhesive on lesions Thrice daily (morning, afternoon and at night) after taking food, for 4 weeks(first visit,2nd week,3rd week and fourth week from first day). Neither patients nor investigator will be aware of which medication is being administered. In Group B, the patients will be using 0.05% Clobetasol propionate on the lesion thrice daily (morning and afternoon, night), for 4 weeks (first visit,2nd week,3rd week and fourth week from first day). All the patients will be instructed to breathe through the mouth before drug use to make the surface dry and then place the mucoadhesive on the lesion and wait for 1 min for its attachment. The patients will be asked to avoid eating, drinking and mouth washing for at least 10–15 min. They are also asked about drug compliance and side effects of gastrointestinal system, rash, fever, and headache each week(4 visits) and by phone calls between weekly visits.On every first visit,VAS score and reduction of lesion size will be recorded and data will be analysed and compared to assess the efficacy of both the topical ointments and also to compare the efficacy of both the ointments by using statistical tests.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Investigator Blinded

入排标准

年龄范围
25.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 1.Subjects clinically diagnosed with oral erosive lichen planus.

排除标准

  • 1.Lichen planus associated with amalgam restorations.
  • 2.Asymptomatic oral lichen planus.
  • 3.Subjects with uncontrolled diabetes.
  • 4.Subjects with pregnancy and lactating mothers.

结局指标

主要结局

1.Efficacy of 2% topical mycophenolate mofetil ointment

时间窗: first day and 2nd,3rd,4th week from the first visit

2.Efficacy of 0.05% clobetasol ointment

时间窗: first day and 2nd,3rd,4th week from the first visit

3.Comparative efficacy of both the ointments

时间窗: first day and 2nd,3rd,4th week from the first visit

次要结局

  • 1.VAS score of both the ointments(2.comparison pf both the ointments in case of remission of lesion)

研究者

发起方
Dr L Krishna Prasad
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Peetha Krupavathi

SIBAR institute of dental sciences

研究点 (1)

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