EUCTR2021-006883-25-DK进行中（未招募）1 期
The Pathogenic Role Of Staphylococcus Aureus And The Skin Microbiome During Flare And Resolution Of Atopic Dermatitis - Staphylococcus aureus, the skin microbiome and atopic dermatitis
Bispebjerg hospital, Dermato-Venerologisk afdeling, Jacob Pontoppidan Thyssen0 个研究点目标入组 45 人开始时间: 2022年4月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •INCLUSION CRITERIA:
- •-Age 18 years or above
- •-European ancestry
- •-AD diagnosis according to Hanifin & Rajka criteria
- •-AD for at least 3 years
- •-AD that is moderate-to-severe defined as an EASI score of = 7
- •-AD in the sampled location that has an TLSS score of = 5
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 45
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •EXCLUSION CRITERIA:
- •-Current or present systemic immunosuppressant and/or biological treatment for the past 4 weeks
- •-Evidence of other concomitant inflammatory skin conditions (e.g., psoriasis or contact dermatitis)
- •-Evidence of active skin infection that warrants treatment at screening or baseline visit
- •-Systemic or topical antibiotics in the preceding past 4 weeks
- •-Use of disinfectants, bleach and potassium permanganate baths at least 2 weeks before sampling
- •-UV therapy within the last 3 weeks, or pronounced exposure to sunlight in the preceding 2 weeks
- •-History of any condition (e.g. bleeding diathesis) that may predispose the patient to complications associated with the planned skin biopsy procedures
- •-Other clinically significant medical disease that is uncontrolled despite treatment that is likely, in the opinion of the investigator, to impact the patient’s ability to participate in the study or to impact the study pharmacodynamic, or safety assessments
- •-Decreased kidney function (GFR under 60 ml/min)
- •-Tendency to formation of keloid scars
- •-Penicillin or mometasone futurate allergy or intolerance
- •-Pregnancy
- •-Breast feeding
- •-Body weight = 40 kg
- •-AD only located in the face or intimate regions
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