A Phase 0 Study Exploring the Use of Induced Skin Blisters in Adult Subjects With Atopic Dermatitis, Allergic Asthma and Atopic Healthy Subjects.
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 7
- 主要终点
- Cell Concentration in Suction Skin Blister Fluid After Allergic Skin Reaction (ASR) Induction with D. Pteronyssinus (House Dust Mite [HDM]), Alternaria alternata, or Aspergillus fumigatus Allergens
研究概览
简要总结
The purpose of this study is to characterize the cell (the basic building block of all living things) populations and inflammatory (pain and swelling) mediator responses in suction skin blister fluid after allergic skin reaction (ASR) [rash] induction with D. Pteronyssinus [house dust mite (HDM)], Alternaria alternata, or Aspergillus fumigatus allergens in participants with atopic dermatitis (AD) [Skin rash, Eczema] or allergic asthma (AA) [breathing disorder in which there is a wheezing and difficulty breathing].
详细描述
This is an interventional (a treatment given during the course of a research study) and multicenter (when more than one hospital or medical school team work on a medical research study) study. The study will consist of 3 Phases: Screening Phase (Up to 4 weeks), Data Collection Phase (9 days) and, Follow-up Phase (7 days). The maximum study duration for each participant will not exceed 43 days. Primarily, the cell populations and inflammatory mediator responses in suction skin blister fluid after allergic skin reaction (ASR) will be assessed. Participants' safety will be monitored throughout the study.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant must have signed an informed consent document prior to any study related procedures indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
- •Participant must be willing/able to adhere to the study visit schedule and other requirements, prohibitions and restrictions specified in this protocol
- •* For participants with Asthma:
- •Participant must have a physician documented diagnosis of asthma for at least 12 months before Screening
- •Participant must have an Asthma Control Questionnaire 6 (ACQ6) less than (<) 1.5 at Screening
- •* For participants with Atopic Dermatitis:
- •Participant must have a physician documented diagnosis of atopic dermatitis for at least 12 months before Screening based on UK refinement of the Hanifin and Rajka's diagnostic criteria
- •Participant must have atopic dermatitis with and Investigators Global Assessment (IGA) score of 2 to 4 at Screening
排除标准
- •Participant has taken any prohibited or restricted medications as noted below under Prestudy and Concomitant Therapy
- •Participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 6 weeks or 5 half-lives (whichever is longer) before the Screening visit
- •* For participants with Asthma:
- •Participant has a history of life-threatening asthma, defined as a history of respiratory arrest or requiring intubation for asthma
- •Participant had been admitted to a hospital for asthma in the 1 year before Screening
- •* For participants with Atopic Dermatitis:
- •Participant has evidence of any other skin condition that would interfere with assessment of Atopic Dermatitis (AD)
- •Participant has active AD related infection or has had an active AD infection within 2 weeks of Screening (participants with evidence of colonization on skin swab testing but with no infection are allowed)
结局指标
主要结局
Cell Concentration in Suction Skin Blister Fluid After Allergic Skin Reaction (ASR) Induction with D. Pteronyssinus (House Dust Mite [HDM]), Alternaria alternata, or Aspergillus fumigatus Allergens
时间窗: Hour 4 after the end of the blister induction
Cells in the aspirated skin blister fluid will be separated and processed for cell population analysis by flow cytometry and messenger RNA (mRNA) analysis.
Cell Concentration in Suction Skin Blister Fluid After ASR Induction with D. Pteronyssinus (House Dust Mite), Alternaria alternata, or Aspergillus fumigatus Allergens
时间窗: Hour 24 after the end of the blister induction
Cells in the aspirated skin blister fluid will be separated and processed for cell population analysis by flow cytometry and mRNA analysis.
Levels of Inflammatory Mediators in Suction Skin Blister Fluid After ASR Induction with D. Pteronyssinus (House Dust Mite), Alternaria alternata, or Aspergillus fumigatus Allergens
时间窗: Hour 24 after the end of the blister induction
The remaining fluid from aspirated skin blister fluid after separated and processed for cell population analysis will be assessed for inflammatory mediator responses. Inflammatory cytokines and other soluble mediators in blister fluid will be measured by immunoassay.
次要结局
- Success Percentage of Repeated Skin Blister Induction and Blister Fluid Aspiration(Day 1 and 8)
- Cell Concentration in Suction Skin Blister Fluid After ASR Induction with Non-protease Allergens(4 and 24 Hours after the end of the blister induction)
- Levels of Inflammatory Mediators in Suction Skin Blister Fluid After ASR Induction with Non-protease Allergens(4 and 24 Hours after the end of the blister induction)