Pragmatic Randomized Controlled Multi Center Trial Comparing the Effectiveness of Antibacterial Therapeutic Clothing Based on Silver or Chitosan as Compared With Non-antibacterial Therapeutic Clothing in Patients With Moderate to Severe Atopic Dermatitis
试验速览
- 阶段
- 不适用
- 入组人数
- 165
- 试验地点
- 2
- 主要终点
- Change in the Eczema Area and Severity Index (EASI)
研究概览
简要总结
Since 2000 therapeutic clothing or functional textiles based on silver or chitosan as antibacterial agents were introduced as therapeutics of atopic dermatitis (AD). These agents aim to reduce skin colonization with Staphylococcus (S.) aureus. S. aureus induces further dysregulation of the inflammatory process and increased colonization with S. aureus is correlated with increased AD severity. Based on the theoretical mode of action and clinical experience, we assume a higher effectiveness of antimicrobial therapeutic clothing compared to control therapeutic clothing on reducing AD severity. The goal of this study is to assess the effectiveness of antibacterial clothing based on silver or chitosan on the doctor-reported AD severity in patients with moderate to severe AD. Secondary goals are to retrieve information about the effect of antimicrobial clothing on clinical symptoms, quality of life, S. aureus colonization, AD medication use and the satisfaction regarding the clothing.
详细描述
This is a multi-center, double-blind, randomized controlled trial. Patients will be randomized in a 1:1:1 fashion to either therapeutic clothing without antimicrobial agents, antimicrobial therapeutic clothing based on chitosan or antimicrobial clothing based on silver for 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Atopic dermatitis diagnosed according to the criteria of Williams (Williams 1994)
- •Atopic dermatitis severity according to EASI at t = 0: > 6.0.
排除标准
- •Treatment with oral antibiotics until 1 month before inclusion;
- •Treatment with topical antibiotics until 1 week before inclusion;
- •Treatment with systemic immunosuppressive agents or light therapy until 1 month before inclusion;
- •Treatment with (antibacterial) therapeutic clothing until 1 month before inclusion;
- •Impaired kidney function (anamnestic assessed)
- •Pregnancy or pregnancy wish during study (anamnestic assessed)
- •Hypersensitivity to silver (anamnestic assessed)
- •Evidence of past non-compliance to treatments or appointment
结局指标
主要结局
Change in the Eczema Area and Severity Index (EASI)
时间窗: Two weeks for baseline, baseline, 1 month, 3 months 6 months and 12 months
Change in disease severity measured by the EASI between the clothing without antimicrobial agents (control group) and microbial growth reducing/ antimicrobial clothing based on chitosan or silver (intervention groups) over 12 months. Minimum score is 0, maximum score is 72. A higher score indicates more sever eczema
次要结局
- Change in the Patient Oriented Eczema Measure (POEM)(Baseline, 1 month, 3 months 6 months and 12 months)
- Change in the Dermatology Life Quality Index (DLQI)(Baseline, 1 month, 3 months 6 months and 12 months)
- Change on the visual analogue scale (0-100 mm) for pain (VAS for pain)(Baseline, 1 month, 3 months 6 months and 12 months)
- Change in the Infant Dermatology Life Quality Index (IDLQI)(Baseline, 1 month, 3 months 6 months and 12 months)
- Use emollients(Through study completion, 1 year)
- Use of antibiotics(Through study completion, 1 year)
- Change in the Child Dermatology Life Quality Index (CDLQI)(Baseline, 1 month, 3 months 6 months and 12 months)
- Dermatitis Family Impact (DFI) - a standardized questionnaire that measures the impact of a skin disease on the family of the patient(Baseline, 3 months, 6 months and 12 months)
- Family Dermatology Life Quality (FDLQI) - a standardized questionnaire that measures the impact of a skin disease on family members(Baseline, 3 months, 6 months and 12 months)
- Quality of life (measured by the TAPCOL)(Baseline, 3 months, 6 months and 12 months)
- Quality of life (measured by the TAAQOL )(Baseline, 3 months, 6 months and 12 months)
- Change in global assessment of degree of impetiginisation(Baseline, 1 month, 3 months 6 months and 12 months)
- Change in Patient global assessment (PGA) of disease severity(Baseline, 1 month, 3 months 6 months and 12 months)
- Change in S. Aureus colonization(Baseline, 1 month, 3 months 6 months and 12 months)
- Change on the visual analogue scale (0-100 mm) for itch (VAS for itch)(Baseline, 1 month, 3 months 6 months and 12 months)
- Quality of life (measured by the TACQOL )(Baseline, 3 months, 6 months and 12 months)
- Change of silver excretion in urine(Baseline, 1month, 3 months, 6 months and 12 months)
- Change on the visual analogue scale (0-100 mm) for sleep disturbance (VAS for sleep disturbance)(Baseline, 1 month, 3 months 6 months and 12 months)
- Use of topical corticosteroids(Through study completion, 1 year)
- Use of therapeutic clothing(Through study completion, 1 year)
- Quality-adjusted life year(Baseline, 1 month, 3 months 6 months and 12 months)
- Recap of atopic eczema (RECAP) - a standardized questionnaire that measures (long term) AD control(Baseline, 1 month, 3 months, 6 months and 12 months)
- Parenting Stress Questionnaire(Baseline, 3 months, 6 months and 12 months)
研究者
Suzanne G.M.A. Pasmans
Principal Investigator, MD, PhD Professor
Erasmus Medical Center