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ID
Source
Brief title
Health condition
Atopic dermatitis
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference in disease severity measured by the EASI by between the clothing without antimicrobial agents (control group) and microbial growth reducing/ antimicrobial clothing based on chitosan or silver (intervention groups) over 12 months
Secondary outcome
- Difference in corticosteroid ointment or cream between the clothing without antimicrobial agents (control group) and microbial growth reducing/ antimicrobial clothing based on chitosan or silver (intervention groups) assessed in the periods, 0 - 1 months, 1 - 3 months, 3 - 6 months, 6 - 12 months
- Difference in investigator global assessment between the clothing without antimicrobial agents (control group) and microbial growth reducing/ antimicrobial clothing based on chitosan or silver (intervention groups) assessed in the periods, 0 - 1 months, 1 - 3 months, 3 - 6 months, 6 - 12 months
- Difference in patient global assessment between the clothing without antimicrobial agents (control group) and microbial growth reducing/ antimicrobial clothing based on chitosan or silver (intervention groups) assessed in the periods, 0 - 1 months, 1 - 3 months, 3 - 6 months, 6 - 12 months
- Difference in global assessment of degree of impetiginisation (pustules, oozing, crust formation) of dermatitis between the clothing without antimicrobial agents (control group) and microbial growth reducing/ antimicrobial clothing based on chitosan or silver (intervention groups), expressed as 0 – no impetiginisation, 1 – sporadic impetiginisation, 2 – mild impetiginisation, 3 – moderate impetiginisation, 4 – severe impetiginisation
- Difference in S. aureus colonization (semi-quantitative culture) between the clothing without antimicrobial agents (control group) and microbial growth reducing/ antimicrobial clothing based on chitosan or silver (intervention groups) over 12 months;
- Difference in POEM or POEM for proxy completion in the case of children up to 10 years of age by their parents between the clothing without antimicrobial agents (control group) and microbial growth reducing/ antimicrobial clothing based on chitosan or silver (intervention groups) over 12 monhts
- Difference in IDLQI<4 years, CDLQI < 16 years or DLQI ≥ 16 years between the clothing without antimicrobial agents (control group) and microbial growth reducing/ antimicrobial clothing based on chitosan or silver (intervention groups) over 12 months
- Difference in DFI in patients <18 years between the clothing without antimicrobial agents (control group) and microbial growth reducing/ antimicrobial clothing based on chitosan or silver (intervention groups) over 12 months.
- Difference in FDLQI of parents in patients <18 years and partners in patients >18 years between the clothing without antimicrobial agents (control group) and microbial growth reducing/ antimicrobial clothing based on chitosan or silver (intervention groups) over 12 months.
- Difference in TAPQQOL in patients <6 years, TACQOL in patients <16 and TAAQOL in patients >16, between the clothing without antimicrobial agents (control group) and microbial growth reducing/ antimicrobial clothing based on chitosan or silver (intervention groups) over 12 months.
- Difference in degree of itching, expressed on a visual analogue scale (0-100 mm), between the clothing without antimicrobial agents (control group) and microbial growth reducing/ antimicrobial clothing based on chitosan or silver (intervention groups) over 12 months
- Difference in degree of sleep disturbance, expressed on a VAS (0-100 mm), between the clothing without antimicrobial agents (control group) and microbial growth reducing/ antimicrobial clothing based on chitosan or silver (intervention groups) over 12 months
Difference in degree of pain, expressed on a VAS (0-100 mm), between the clothing without antimicrobial agents (control group) and microbial growth reducing/ antimicrobial clothing based on chitosan or silver (intervention groups) over 12 months
- Difference in degree of bother, expressed on a visual analogue scale (0-100 mm), between the clothing without antimicrobial agents (control group) and microbial growth reducing/ antimicrobial clothing based on chitosan or silver (intervention groups) over 12 months
- Difference in degree of satisfaction and compliance regarding the clothing medication diary including use of emollients between the clothing without antimicrobial agents (control group) and microbial growth reducing/ antimicrobial clothing based on chitosan or silver (intervention groups) over 12 months
- Difference in control of atopic dermatitis (bases on RECAP questionnaire) between the clothing without antimicrobial agents (control group) and microbial growth reducing/ antimicrobial clothing based on chitosan or silver (intervention groups) over 12 months
- Difference in antibiotics and topical treatment between the clothing without antimicrobial agents (control group) and microbial growth reducing/ antimicrobial clothing based on chitosan or silver (intervention groups) over 12 months
- Difference in the QALYs based on EuroQol questionnaire between the clothing without antimicrobial agents (control group) and microbial growth reducing/ antimicrobial clothing based on chitosan or silver (intervention groups) over 12 months
Background summary
Atopic dermatitis (AD) is a chronic inflammatory skin disease that affects 10% to 20% of children and between 2% and 15% of the adults in Western Europe. Since 2000 therapeutic clothing or functional textiles based on silver or chitosan as antibacterial agents were introduced as therapeutics of 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. The antimicrobial effects of silver and chitosan have been demonstrated before. 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.
Study objective
Antimicrobial therapeutic clothing are more effective in reducing the severity of atopic dermatitis than non-antimicrobial therapeutic clothing
Study design
T= -2 weeks, baseline, 1 month, 3 months, 6 months and 12 months
Intervention
The control group will receive non-antimicrobial therapeutic clothing.
The chitosan group will receive antimicrobial therapeutic clothing based on chitosan
The silver group will receive antimicrobial therapeutic clothing based on silver
All therapeutic clothing is to be worn at night during the 12-month intervention period and if needed during the day
Inclusion criteria
- AD diagnosed according to the criteria of Williams (Williams 1994);
- Age 0 - 80 years;
- AD severity according to EASI at t = 0 >6.0.
Exclusion criteria
- 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 appointments.
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL7982 |
| Other | METC Rotterdam : MEC-2018-1609 |