Effect of S. Aureus Skin Decolonization on Disease Severity in Atopic Dermatitis Patients
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Severity Scoring of Atopic Dermatitis Index
研究概览
简要总结
Our hypothesis is that S. aureus skin decolonization in atopic dermatitis reduces disease severity and favorably alters the function and gene expression of epidermal and immune skin cells that contribute to disease severity.
详细描述
Patients will sign an informed consent and assent to participate. Skin and both nares will be cultured for S aureus. A blood sample and two 2 mm skin biopsies will be obtained one from non-lesional skin and another one from lesional skin). The patients will be instructed in the use of the three-week S. aureus decolonization regimen and provided with the medications (sulfamethoxazole/trimethoprim and Mupirocin ointment) and Chlorhexidine. The second visit will take place immediately at the end of the three-week S. aureus skin decolonization regimen. Disease severity will be assessed, the skin and nares will be re-cultured, and skin biopsies and blood will be obtained.
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
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants ≥6 yrs of age
- •Meet atopic dermatitis Standard Diagnostic Criteria
- •SCORAD > 40.
排除标准
- •. Enrollment in another clinical trial
- •Hypersensitivity to an agent used for the skin decolonization protocol
- •Use within 4 weeks of systemic treatment with immunosuppressive/immunomodulating drugs (corticosteroids, cyclosporine, mycophenolate, azathioprine, methotrexate)
- •Phototherapy for AD within 4 weeks
- •Treatment with biologics (dupilumab, omalizumab, benralizumab, etc) within sixteen weeks
- •Use of topical steroids, topical calcineurin inhibitors within 7 days
- •Bleach baths within 7 days of the first Visit
- •Use of oral or topical antibiotics within 21 days of the beginning of the study
- •Asthmatics receiving more than 500 μg per day of inhaled corticosteroids
- •History of (HIV, hepatitis B, hepatitis C, tuberculosis malignancy
- •Skin comorbidities that may interfere with assessments: psoriasis, cutaneous T Cell lymphoma,,
- •Severe ongoing medical illnesses e.g. cardiovascular, renal disease, autoimmune disease.
- •Febrile illness at time of visits
- •Suspected immune deficiency or family history of primary immunodeficiency
研究组 & 干预措施
Skin Cleansing Regimen
- Mupirocin 2% nasal ointment to the anterior nares to be applied twice daily
- Chlorhexidine 4% topical soap (Hibiclens) to be used every other day in the shower or bath from the neck down and then completely rinsed.
- Sulfamethoxazole/trimethoprim (Bactrim): one double strength (DS) tablet (800 mg/160 mg) twice per day for adolescents and adults
干预措施: Skin Cleanser Combination No.1 (Drug)
结局指标
主要结局
Severity Scoring of Atopic Dermatitis Index
时间窗: 3 weeks
severity index
次要结局
未报告次要终点
研究者
Wanda Phipatanakul
S. Jean Emans, MD Professor of Pediatrics
Harvard Medical School (HMS and HSDM)