NCT04274595已完成不适用
Role of Reverse Transcriptase Inhibitors in the Treatment of Psoriasis: A Proof of Biological Concept Test
Centre Hospitalier Universitaire de Nīmes2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2020年2月13日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Percentage of patients no longer presenting S9.6:D5H6 RNA:DNA duplex
研究概览
简要总结
The investigators hypothesize that the inhibition of endogenous reverse transcriptase would: (1) reduce excess cytosolic DNA, stress initiating the inflammatory loop at the origin of psoriatic lesions, and (2) interrupt the loop and lighten lesions
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient suffering from plaque psoriasis for more than a year with at least one active skin lesion> 4 cm2 in the photo-protected area.
- •Patient using effective contraception (IUD, adapted pill, condom, etc.)
- •The patient must have given their free and informed consent and signed the consent form
- •The patient must be a member or beneficiary of a health insurance plan
排除标准
- •Patient with another form or stage of psoriasis
- •Patient on anti-cytokine treatment during the 6 months (180 days) before inclusion
- •Patient under systemic treatment based on (1) corticosteroids, (2) antibiotics, (3) methotrexate, ciclosporin, soriatane, hydroxyurea, apremilast or (4) PUVA, (5) UVB, (6) vitamin D3 during the 4 weeks (28 days) before inclusion
- •Patient on topical corticosteroid or retinoid treatment during the 2 weeks (15 days) before inclusion
- •Patient with renal insufficiency; taking nephrotoxic agents (aminoglycosides, multiple or high doses of NSAIDs, etc.); creatinine clearance less than 50 ml / min; serum phosphorus below 1.0 mg / dl (0.32 mmol / l).
- •Patient with active viral infection (HBV, HCV and HIV), or uncontrolled acute infection.
- •Patient with hypersensitivity to one of the active substances or to any of the excipients (non-medicinal ingredients).
- •Patient with uncontrolled coagulation disorder, history of keloid scars
- •Patient with an allergy to local anesthetics; any condition likely to interfere at the time of the pre-inclusion visit, with the evaluation of the main objective such as eczema, psychiatric disorders
- •Patient with uncontrolled systemic parameters The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
研究组 & 干预措施
Psoriasis patients
Experimental
干预措施: Generic antiretroviral (Drug)
结局指标
主要结局
Percentage of patients no longer presenting S9.6:D5H6 RNA:DNA duplex
时间窗: Day 7
Biopsy screening for S9.6:D5H6 RNA:DNA duplex by immunofluorescence
次要结局
- Percentage change in Ki67 proliferation marker expression(Day 7)
- Percentage change in filaggrin differentiation marker expression(Day 7)
- Percentage change in CD4 inflammation marker expression(Day 7)
- Percentage change in CK10 differentiation marker expression(Day 7)
- Percentage change in CD11c inflammation marker expression(Day 7)
- Percentage change in endogenous reverse transcriptase(Day 7)
- Percentage change in CD8 inflammation marker expression(Day 7)
- Average percentage change of Psoriasis Area Severity Index(Day 7)
- Number of side effects(Day 14)
研究者
研究点 (2)
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