NCT01929057已完成不适用
Evaluation of the Role of Propionibacterium Acnes in the Inflammatory Lesions Associated With Acne Vulgaris
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Level of IL-1β
研究概览
简要总结
The purpose of this study is to determine the response of acne patients and healthy control patients to the P. acnes bacteria. Half a tube of blood will be drawn from all participants to determine whether or not they have antibodies to the P. acnes bacterium. Anywhere from 1 to 4 skin biopsies of acne pimples or normal control skin will be taken from all subjects for further analysis in the lab to determine whether the inflammation in these pimples can be reduced using anti-P.acnes antibodies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fits into one of the following diagnostic groups:
- •Healthy subject with no active skin disease or history of skin disease
- •Diagnosis of moderate-to-severe truncal acne diagnosed clinically and confirmed using the modified Leeds criteria with no reported use of topical acne treatments within the past 2 weeks prior to enrollment in the study, and no reported use of oral acne treatments during the past 4 weeks prior to enrollment in the study
- •Diagnosis of moderate-to-severe truncal acne diagnosed clinically and confirmed using the modified Leeds criteria who has used any topical acne treatments in the 2 weeks prior to enrolling in the study, or who has used any oral acne treatments during the 4 weeks prior to enrolling in the study
- •Age 18-60 years
- •Male or female of any race and ethnicity
- •Subject agrees to comply with study requirements
排除标准
- •Subjects with severe medical condition(s) that in the view of the investigator prohibits participation in the study
- •Subject has Netherton's syndrome or other genodermatoses that result in a defective epidermal barrier
- •Pregnant or nursing females
- •Immunocompromised subjects (e.g., lymphoma, HIV/AIDS, Wiskott-Aldrich Syndrome), or with a history of active or malignant disease (excluding non-melanoma skin cancer) as determined by the participant's medical history.
- •Subjects with a history of psychiatric disease or history of alcohol or drug abuse that would interfere with the ability to comply with the study protocol
- •Subjects with significant concurrent medical condition(s) at screening that in the view of the investigator prohibits participation in the study (e.g., severe concurrent allergic disease, condition associated with malignancy, and condition associated with immunosuppression)
- •Active viral or fungal skin infections at the target areas
- •Are currently receiving lithium now or within the last 4 weeks.
- •Ongoing participation in an investigational drug trial
- •Use of any systemic immunosuppressive therapy less than four weeks prior to screening.
- •Subjects with diabetes
- •Injured, broken skin that, per the investigator, may lead to poor wound healing
- •Subjects with allergies to anesthetic medications
结局指标
主要结局
Level of IL-1β
时间窗: post biopsy
The amount of IL-1β, an inflammatory marker, is measured in skin biopsies obtained from healthy patients and compared with levels in biopsies of acne lesions.
次要结局
- Level of Antibody to CAMP(Christie-Atkins-Munch-Petersen) Factor(post biopsy)
研究者
Tissa Hata, MD
MD
University of California, San Diego
研究点 (1)
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