CTRI/2020/05/025197进行中（未招募）4 期
Evaluation of efficacy and safety of apremilast in management of lichen planus.
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
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.Both male and female patients aged >= 18 years and <= 60 years.
- •2.Patients with history of cutaneous or mucosal lichen planus.
- •3.Patients with a PGA score of 3 or more.
- •4.Patients with biopsy/dermoscopy confirmed lichen planus.
- •5.Patients who are candidates for systemic therapies.
- •6.Patients who are refractory to treatment with topical corticosteroids.
- •7.Patients who are ready to give written informed consent, which includes a commitment to comply with all requirements, specified in the study protocol.
排除标准
- •1.Patients with lichen sclerosis et atrophicus (LS&A)
- •2.Clinical history and lesion distribution suspicious for a lichenoid drug eruption
- •3.Pregnant or nursing females.
- •4.Other skin disease that might interfere with lichen planus assessments.
- •5.Patients with known hypersensitivity to the study drugs.
- •6.Patients with immunosuppressive disease or on immunosuppressive drugs.
- •7.Patients with liver dysfunction.
- •8.Patients with a history of seizures
- •9.Patients with history of psychiatric disorders.
- •10.Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the Investigator(s) could affect the subjectâ??s safety or interfere with the study assessments.
- •11.Active severe infections, or prior infection requiring hospitalization or oral/intravenous antibiotics within 4 weeks before screening visit, or between the screening and baseline visits.
- •12.Any history of or concomitant medical condition that in the opinion of the Investigator(s) would compromise the subjectâ??s ability to safely complete the study.
- •13.History of drug or alcohol dependency or abuse within approximately the last 2 years.
- •14.Currently enrolled in another clinical study or used any investigational drug or device within 30 days preceding informed consent or were scheduled to participate in another clinical study that involved an investigational product or investigational drug during the course of this study.
- •15.Any patient whom the investigator judged to be inappropriate for this study.
研究者
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