Antimicrobial therapeutic clothing are more effective in reducing the severity of atopic dermatitis than non-antimicrobial therapeutic clothing
ID
Bron
Verkorte titel
Aandoening
Atopic dermatitis
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Antimicrobial therapeutic clothing are more effective in reducing the severity of atopic dermatitis than non-antimicrobial therapeutic clothing
Onderzoeksopzet
T= -2 weeks, baseline, 1 month, 3 months, 6 months and 12 months
Onderzoeksproduct en/of interventie
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
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- AD diagnosed according to the criteria of Williams (Williams 1994);
- Age 0 - 80 years;
- AD severity according to EASI at t = 0 >6.0.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7982 |
| Ander register | METC Rotterdam : MEC-2018-1609 |