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首页> 外文期刊>Trials >The efficacy of a cyclin dependent kinase 9 (CDK9) inhibitor, FIT039, on verruca vulgaris: study protocol for a randomized controlled trial
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The efficacy of a cyclin dependent kinase 9 (CDK9) inhibitor, FIT039, on verruca vulgaris: study protocol for a randomized controlled trial

机译：细胞周期蛋白依赖性激酶9（CDK9）抑制剂FIT039对寻常疣的功效：一项随机对照试验的研究方案

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Human papilloma viruses (HPVs) infect squamous epithelial cells and form verrucous lesions, or warts. Besides the psychosocial problems caused by the disfiguring warts, a subset of HPVs can be the primary etiologic agent for malignancies such as cervical cancer. However, there is no curative antiviral therapy for HPV infection. We recently found that the viral RNA transcription of DNA viruses requires cyclin dependent kinase 9 (CDK9) in the host cells, and that FIT039, a specific inhibitor of CDK9, suppressed the proliferation of DNA viruses such as herpes simplex virus 1 (HSV-1), HSV-2, human adenovirus, human cytomegalovirus, hepatitis virus B, and HPVs. Here, we describe a protocol to evaluate the safety and antiviral effect of FIT039 on common warts in human skin. A multi-institutional, single-blind, placebo-controlled randomized phase I/II clinical trial was designed to evaluate the safety and efficacy of FIT039 on common warts on the extremities. A total of 44 adults with a primary diagnosis of verruca vulgaris on the extremities without serious comorbidities will be randomized into either the intervention group with an FIT039-releasing transdermal patch or a control group for a duration of 14?days. Outcomes will be assessed at baseline and postintervention. Participants will be further assessed at 2 months follow-up. The primary endpoint for efficacy is the resolution of the warts. The safety endpoint is the incidence of adverse events and adverse drug reactions. The secondary endpoints are changes in the dimensions of the wart, the cross-sectional area of the wart, and the number of clots within the area of the wart. This study is the first to assess the efficacy of FIT039 and will contribute to the development of antiviral agents that can cure refractory common warts in immunocompromised patients. UMIN Clinical Trials, UMIN000029695 . Registered on 1 November 2017.
机译：人乳头瘤病毒（HPV）感染鳞状上皮细胞并形成疣状病变或疣。除了由疣变造成的社会心理问题外，一部分HPV可能是导致子宫颈癌等恶性肿瘤的主要病因。但是，目前尚无针对HPV感染的治愈性抗病毒药物。我们最近发现，DNA病毒的病毒RNA转录在宿主细胞中需要细胞周期蛋白依赖性激酶9（CDK9），而CDK9的特异性抑制剂FIT039抑制了DNA病毒（如单纯疱疹病毒1（HSV-1） ），HSV-2，人腺病毒，人巨细胞病毒，乙型肝炎病毒和HPV。在这里，我们描述了一种协议，以评估FIT039对人类皮肤中常见疣的安全性和抗病毒作用。设计了一种多机构，单盲，安慰剂对照的随机I / II期临床试验，以评估FIT039对四肢常见疣的安全性和有效性。总共44名初步诊断为四肢寻常疣而无严重合并症的成人将被随机分为具有FIT039释放透皮贴剂的干预组或对照组，为期14天。将在基线和干预后评估结果。将在2个月的随访中进一步评估参与者。功效的主要终点是疣的消退。安全终点是不良事件和不良药物反应的发生率。次要终点是疣的尺寸，疣的横截面积以及疣区域内的凝块数的变化。这项研究是第一个评估FIT039疗效的研究，将有助于开发可治愈免疫受损患者难治性普通疣的抗病毒药物。 UMIN临床试验，UMIN000029695。 2017年11月1日注册。

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