Evaluation of the Effect of Methotrexate on Cytokines and Chemokines Involved in the Inflammatory Response in Adult Patients With Atopic Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change from baseline of cytokines and chemokines expression at 24 weeks
研究概览
简要总结
Atopic dermatitis (AD) is a chronic inflammatory skin disease associated with pruritus. Methotrexate can be used to treat refractory disease to conventional therapy.
It will be conducted a single arm trial with twelve adult patients with moderate to severe AD on methotrexate for 24 weeks.
Investigators intend to evaluate the effect methotrexate on cytokines and chemokines involved in the inflammatory response, on IgE levels, on pruritus, and on EASI and SCORAD severity scores.
详细描述
Introduction: Atopic dermatitis (AD) is a chronic inflammatory skin disease associated with pruritus. Methotrexate (MTX) can be used to treat refractory disease to conventional therapy, but there are few studies showing its effect on the profile of cytokines involved in the inflammatory response.
Objectives: To assess the effect of MTX on the cytokines involved in the inflammatory response of adult AD patients treated with methotrexate for 24 weeks. As specific objectives, investigators intend to assess the evolution of serum IgE levels, the EASI (Eczema Area and Severity Index) and SCORAD (Scoring Atopic Dermatitis) severity scores and pruritus in them.
Methods: It will be conducted an open, prospective study with twelve adult patients with moderate to severe AD on MTX for 24 weeks. Each participant is expected to attend 7 visits during 6 months of follow-up. In clinical healthy and injured skin, two assessments will be performed: 1) mRNA expression of IL-4, IL-10, IL-17A, IL-22, IL-31, oncostatin M receptor (OSMR), alpha subunit IL-31 (IL-31RA) receptor, TNF-α, IFN-γ, TSLP, TARC and MDC by Real Time-PCR at the initial week and week 24; 2) expression of IL-31, IL-31RA, OSMR, TSLP and Ki67 by immunohistochemistry at the initial week and week 24.
Skin samples from non-atopic subjects will be utilized as controls for the assays, paired by gender and age.
Additional analysis of serum levels of IgE (nephelometric method) at the initial week and week 24 of the study will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AD (Hanifin and Rajka criteria) moderate to severe (EASI ≥ 7.1 and SCORAD ≥ 25);
- •Age ≥ 18 years;
- •Women without the potential to become pregnant or using an effective method of contraception and with a negative pregnancy blood test;
- •Men without a desire of pregnancy and who use condom in sexual intercourse.
排除标准
- •Hepatic and / or renal insufficiency;
- •Anemia, thrombocytopenia and / or leukopenia;
- •Use of concomitant hepatotoxic drug;
- •Active infection;
- •Allergy to MTX;
- •Excessive alcohol intake;
- •Difficulty to understand how to take methotrexate;
- •HIV infection or other immunosuppression condition;
- •Therapy with UVA or UVB, corticoid, cyclosporine, immunobiological, azathioprine within 12 weeks prior to introduction of methotrexate.
研究组 & 干预措施
Methotrexate
干预措施: Methotrexate (Drug)
结局指标
主要结局
Change from baseline of cytokines and chemokines expression at 24 weeks
时间窗: week 24
mRNA expression of IL-4, IL-6, IL-10, IL-31, TSLP, INF-gamma, TNF-alpha, TARC and MDC by Real Time-PCR. Immunohistochemistry with antibodies against IL-31, IL-31RA, OSMR, TSLP and Ki67
次要结局
- Change from baseline of IgE level at 24 weeks(week 24)
- Change from baseline of Pruritus at 12 weeks(week 12)
- Change from baseline of Pruritus at 24 weeks(week 24)
- Change from baseline of SCORAD severity score at 12 weeks(week 12)
- Change from baseline of SCORAD severity score at 24 weeks(week 24)
- Change from baseline of EASI severity score at 12 weeks(week 12)
- Change from baseline of EASI severity score at 24 weeks(week 24)
研究者
Valéria Aoki
Associate Professor and Director of International Relations
University of Sao Paulo General Hospital