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

  • STATUS
    Recruiting
  • End date
    Jan 1, 2023
  • participants needed
    165
  • sponsor
    Erasmus Medical Center
Updated on 24 January 2021
antibiotics
staphylococcus aureus
antihistamines
atopy

Summary

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.

Description

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.

Details
Condition Eczema, Eczema (Atopic Dermatitis - Pediatric), ATOPIC DERMATITIS, Eczema (Atopic Dermatitis), ATOPIC DERMATITIS, Dermatitis, Atopic, Dermatite Atopique, Eczéma (Dermatite Atopique), Dermatitis, Hand Dermatitis, Eczema (Atopic Dermatitis), Dermatitis, Atopic, Hand Dermatitis, Eczema (Atopic Dermatitis - Pediatric), Eczéma (Dermatite Atopique), Dermatite Atopique
Treatment DermaCura® Chitosan based antimicrobial therapeutic clothing, Binamed® silver based antimicrobial therapeutic clothing, Binamed® therapeutic clothing without antimicrobial agents
Clinical Study IdentifierNCT04297215
SponsorErasmus Medical Center
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Atopic dermatitis diagnosed according to the criteria of Williams (Williams 1994)
Atopic dermatitis 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 appointment
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