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临床试验/CTRI/2015/09/006211
CTRI/2015/09/006211已完成2 期

An open label, single arm, multi-centered study to evaluate the efficacy, safety and tolerability of lipid based tacrolimus ointment 0.1% in patients of oral lichen planus - NA

Intas Pharmaceuticals Ltd0 个研究点目标入组 30 人开始时间: 待定最近更新:

试验速览

阶段
2 期
状态
已完成
入组人数
30

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1.Male or female participants between 18 and 65 years of age
  • 2.Confirmed diagnosis of symptomatic oral lichen planus
  • 3.Symptomatic OLP (Spontaneous or meal related oral pain).

排除标准

  • 1.Asymptomatic lichen planus with no ulcerated or erythematous oral lesions.
  • 2.Who have received systemic immunosuppressants, oral retinoids or any other systemic therapies known or suspected to have an effect on lichen planus within 4 weeks prior to participation in the study.
  • 3.Who have been treated with topical therapy
  • 4.Severe or recurrent systemic or generalized infections (bacterial, viral or fungal).
  • 5.Who have unstable or uncontrolled diabetes or hypertension.
  • 6.Hypersensitivity to tacrolimus or any of the ointment excipients, pimecrolimus, any macrolides such as clindamycin, erythromycin, azithromycin, clarithyromycin, etc.

研究者

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