Evaluation of efficacy and safety of apremilast in management of lichen planus.
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Primary efficacy endpoints: Primary end point the study will be the proportion of patients who achieve a significant clinical response in cutaneous disease, defined as a 2-grade or more improvement in the physician global assessment (PGA) score after 12 weeks of treatment.
研究概览
简要总结
Lichen planus (LP) is a chronic inflammatorydisease that typically affects the skin, mucous membranes, and nails. It isusually associated with significant morbidity such as severe pruritus and pain.The exact cause of lichen planus is unclear however the pathogenesis of lichenplanus involves genetic and immune mediated factors predominantly T-cellmediated inflammatory agents, such as tumor necrosis factor-α and interferon-γ.LP lesions can have a relapsing and remitting clinical course that are very difficultto treat.
Mainstay treatment options for management oflichen planus are topical and oral corticosteroids, retinoids, cyclosporine,griseofulvin, dapsone, and phototherapy. However, these therapies are oftenassociated with less than optimal results and significant adverse side effects.Considering the paucity of available efficacious agents and the severity ofclinical symptoms, there is need for novel efficacious and safer agent inmanagement of lichen planus.
Apremilast is a selective phosphodiesterase 4inhibitor, associated with accumulation of intracellular cyclic adenosinemonophosphate (cAMP) levels. Increased levels of cAMP activate protein kinase Aand effectively inhibit proinflammatory cytokine transcription and neutrophildegranulation, chemotaxis, and adhesion to endothelial cells. Ultimately,Apremilast inhibits the production of various inflammatory mediators, such astumor necrosis factor-α, interferon-γ, leukotriene B4, and interleukin (IL)-2,IL-5, IL-8, and IL-12.
Since Apremilast modulates inflammatory signallingpathways which plays a central role in the pathogenesis of lichen planus, it isplausible that Apremilast may be an effective treatment for lichen planus. Weare planning to conduct this trial with the objective to evaluate the overallefficacy and safety of oral Apremilast in patients with lichen planus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
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 subject’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 subject’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.
结局指标
主要结局
Primary efficacy endpoints: Primary end point the study will be the proportion of patients who achieve a significant clinical response in cutaneous disease, defined as a 2-grade or more improvement in the physician global assessment (PGA) score after 12 weeks of treatment.
时间窗: 12 weeks
次要结局
- The proportion of patients who achieve a significant clinical response in mucosal disease, defined as a 2-grade or more improvement in the physician global assessment (PGA) score(Proportion of patients achieving subject global assessment (SGA) of complete resolution or marked improvement)
- ‘Target area’ is defined as the part of the body with the greatest disease severity; its boundaries are clearly defined and documented at baseline to facilitate future assessments.(Change in mean target lesion symptom score – erythema)
- Safety(Proportion of patients discontinuing therapy with apremilast during study period.)