An Investigator Initiated Study to Evaluate the Efficacy of Baricitinib In Treatment of Delayed-Type Hypersensitivity Versus Irritant Skin Reactions In Healthy Adult Male Subjects
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Number of participants with reduced skin inflammation associated with Delayed-Type Hypersensitivity (DTH) versus irritant skin reactions by pro-inflammatory cytokine profile.
研究概览
简要总结
The treatment of allergic contact dermatitis (ACD) can be unsatisfactory, and that other skin diseases such as atopic dermatitis have an increased likelihood of ACD, improved systemic treatments are needed.
This research study explores the effectiveness of Baricitinib in treating Delayed-Type Hypersensitivity (allergic) versus Irritant Skin reactions. Subjects for this study need to be healthy males between the ages of 18 and 40. This study will evaluate this by injecting antigens as well as applying them on top of the skin to the forearm then measure the effects of Baricitinib by skin and blood testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males 18-40 years of age at the time of signing the informed consent document
- •Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted
- •Able to adhere to the study visit schedule and other protocol requirements
- •Must be in good health as judged by the Investigator, based on medical history and physical examination, and no laboratory abnormalities
排除标准
- •Any known severe allergies to yeast products
- •Currently active skin diseases such as psoriasis, atopic dermatitis, allergic contact dermatitis or irritant contact dermatitis
- •Inability to understand informed consent
- •Any medical condition that the investigator feels would interfere with study
- •Any abnormalities on physical exam or screening laboratory studies (to progress to Part II)
- •Agree to discontinue use of prohibited medications at least 4 weeks prior to screening:
- •topical corticosteroids, oral or injectable systemic steroids, systemic immunomodulators (cyclosporine, methotrexate, etc.), oral or topical antihistamines
- •Positive reaction to tuberculin test (PPD) or negative control
- •Negative reaction to initial skin testing for Candida, Trichophyton, or Sodium Laurel Sulfate
研究组 & 干预措施
Subjects Taking Baricitinib 2 mg
Subjects will be taking Baricitinib 2mg
干预措施: Baricitinib (Drug)
Subjects Taking Placebo
Subjects will be taking placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with reduced skin inflammation associated with Delayed-Type Hypersensitivity (DTH) versus irritant skin reactions by pro-inflammatory cytokine profile.
时间窗: Day 28
Investigator will assess the skin inflammation reduction as measured by pro-inflammatory cytokine profile associated with DTH versus irritant skin reactions.
Number of participants with reduced skin inflammation associated with Delayed-Type Hypersensitivity (DTH) versus irritant skin reactions by erythema measurement.
时间窗: Day 28
Investigator will assess the skin inflammation reduction as measured by erythema associated with DTH versus irritant skin reactions.
Number of participants with reduced skin inflammation associated with Delayed-Type Hypersensitivity (DTH) versus irritant skin reactions by measurement of reaction size.
时间窗: Day 28
Investigator will assess the skin inflammation reduction as measured by reaction size associated with DTH versus irritant skin reactions.
次要结局
- Number of participants with reduced pruritus associated with DTH versus irritant skin reactions.(Day 28)