Characterizing Skin Microbiome Change in Atopic Dermatitis Patients After Targeted Topical Treatment Using Crisaborole Ointment
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To determine a change in skin microbiome taxonomic units after 16 weeks of treatment with Crisaborole in atopic dermatitis.
研究概览
简要总结
Atopic dermatitis (AD), also known as eczema, is an inflammatory disease of the skin affecting a large proportion of the pediatric and adult patient population. Chronic itching and eczematous lesions lead to a high burden of disease and associated patient morbidity with higher infection rates, emotional stress and associated psychological disease. The microbiome community contributes to human health through several mechanisms. Current research suggests that derangements in the normal microbiota may lead to inflammatory bowel disease, allergy, and metabolic syndromes. Specific to dermatology, new literature has demonstrated that changes in the microbiome may play a role in the development of atopic dermatitis.
With this study, the investigators hope to characterize the baseline atopic dermatitis skin microbiome and monitor the evolution of the participants skin microbiome during and after treatment with anti-inflammatory topical medications, specifically the Food and Drug Administration (FDA)-approved phosphodiesterase inhibitor, crisaborole ointment 2% (Eucrisa).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 2 years or older at the time of consent.
- •Patients may be male or female.
- •Patients may have any skin phototype.
- •Patients with a clinical diagnosis of atopic dermatitis according to the Hanifin and Rajka criteria. Atopic dermatitis diagnosis must be stable at least for 1 month per caregiver or patient.
- •Atopic dermatitis affecting at least 5% of the patient's body surface area with at least two distinct lesional sites.
- •Atopic dermatitis must meet a score of mild to moderate on the baseline Investigator's Static Global Assessment (iSGA).
- •If greater than or equal to 18 years old at the time of consent, is able to provide written informed consent and will comply with all study procedures. If less than 18 years old at the time of consent, parent or guardian is able to provide written informed consent with all children greater than or equal to 7 years old at the time of consent also providing written assent, and will comply with all study procedures.
排除标准
- •Patients less than 2 years old at the time of consent.
- •Patients unable to provide written informed consent.
- •Patients must not have used systemic biologic therapy, systemic immunosuppressive therapy, or systemic immunomodulating therapy within three months of baseline visit.
- •Patients must not have had phototherapy within three months of baseline visit.
- •Patients must not have used topical corticosteroids or topical calcineurin inhibitor within 28 days of baseline visit.
- •Patients must not have previously been treated with topical phosphodiesterase-4 inhibitor.
- •Patients must not have a known hypersensitivity reaction to crisaborole or any of its known vehicle components.
- •Patients must not have any active skin infection at the time of screening.
- •Patients must not have any other overlying inflammatory disease such as psoriasis.
- •Patients must not be currently pregnant, breastfeeding or planning pregnancy during the study.
研究组 & 干预措施
Treatment group
干预措施: Crisaborole 2% Top Oint (Drug)
Treatment group
干预措施: Skin Microbiome Swabs (Genetic)
结局指标
主要结局
To determine a change in skin microbiome taxonomic units after 16 weeks of treatment with Crisaborole in atopic dermatitis.
时间窗: 16 weeks
To analyze the atopic dermatitis microbiome using advanced genomic techniques after treatment with topical PDE4 inhibitors. Using 16S library preparation, sequencing, merging of MiSeq paired-end sequence reads, and identification of operational taxonomic units, the investigators hope to identify the bacterial and fungal content of skin microbiome samples from 20 AD participants before and after treatment with crisaborole at a total of 6 visits over 16 weeks.
次要结局
未报告次要终点
研究者
Natasha Mesinkovska
Prinicipal Investigator
University of California, Irvine