Assessing the Impact of Bleach Baths on Itch, Cutaneous Inflammation, Microbial Flora and Skin Barrier Function in Adult Atopic Dermatitis Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Noninvasive barrier measurement called Transepidermal Water Loss (TEWL) done before and after repeated tape stripping
研究概览
简要总结
This is pilot, mechanistic study to address whether bleach baths given to adult subjects with atopic dermatitis or eczema, who are colonized with the bacteria Staphylococcus aureus, will significantly alter their skin microbiome and in so doing improve their skin barrier, diminish expression of inflammatory proteins in the skin and improve itch. To answer these questions the investigators will perform a 3-month, pilot, investigator-initiated, single-center, open-label clinical study. This study will allow us to test the following hypothesis: 1) that bleach baths will normalize skin barrier function, 2) that bleach baths will diminish the local inflammatory response in the skin, and 3) that bleach baths will improve validated measures of itch (also called pruritus).
详细描述
Atopic Dermatitis subjects have different proportions of bacterial communities on their skin surface. Often, their skin is colonized with the pathogenic bacteria called Staphylococcus aureus. Studies have demonstrated a remarkable clinical improvement in Atopic Dermatitis subjects who take bleach baths two times per week for three months. The assumption was that this worked by reducing the S. aureus on the skin surface but by standard culture techniques there was no change in S. aureus colonization. Therefore, the mechanism by which these bleach baths improved the disease remains entirely unknown. This study will assess the effects bleach baths have on bacteria that can and cannot be cultured using new molecular biologic tools that have shown us that the skin is home to thousands of different microbial species. This bacterial ecosystem is called the microbiome. The investigators will also determine whether bleach baths affect skin barrier integrity and the cutaneous expression of lymphocyte-derived cytokines that are thought to cause the skin inflammation in subjects with Atopic Dermatitis. The investigators will also assess to what degree these baths improve disease severity and the symptoms of itch using validated scoring systems. This work will likely uncover new ideas about the pathogenesis of Atopic Dermatitis and may be the first step to developing new pro-microbial and antimicrobial therapeutics.
This study is designed to test the following hypotheses:
- The chronic use of bleach baths will normalize skin barrier function in adult Atopic Dermatitis subjects as measured by physiological measures of barrier in vivo, and as assessed by ex vivo studies (measuring transepithelial electrical resistance (TEER) and permeability of the epidermis from skin biopsies). The investigators will evaluate whether any of the functional changes correlate with changes in expression of relevant tight and intercellular junction molecules at the messenger ribonucleic acid (mRNA) level.
- Bleach baths will improve validated measures of pruritus (itch).
- Bleach baths will diminish the local T-helper 2 (Th2) immune response measured from skin biopsy samples.
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
- 否
入选标准
- •Moderate to severe Atopic dermatitis: Eczema Area and Severity Index (EASI) score ≥
- •Skin culture positive for Staphylococcus aureus
- •Must have active skin disease on the day of enrollment.
排除标准
- •Unwillingness or inability to complete informed consent
- •Lidocaine or Novocain allergy
- •History of keloid formation
- •Course of systemic antibiotics or antivirals within 2 weeks prior to enrollment.
研究组 & 干预措施
Dilute bleach bath
Subjects will take a diluted bleach bath (0.005% Sodium hypochlorite) for 5-10 minutes twice a week for 12 weeks.
干预措施: bleach bath (sodium hypochlorite) (Drug)
结局指标
主要结局
Noninvasive barrier measurement called Transepidermal Water Loss (TEWL) done before and after repeated tape stripping
时间窗: change from baseline after 12 weeks of bleach baths
TEWL will be measured at 3 timepoints throughout the study.
次要结局
- Skin permeability(change from baseline after 12 weeks of bleach baths)
- Itch - 5D pruritus scale(change from baseline after 12 weeks of bleach baths)
- Transepithelial electrical resistance(change from baseline after 12 weeks of bleach baths)
- Tissue expression of relevant inflammatory and epidermal barrier markers(change from baseline after 12 weeks of bleach baths)
- Skin bacterial diversity(change from baseline after 12 weeks of bleach baths)
研究者
Lisa Beck
Professor of Medicine and Dermatology
University of Rochester