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 (ABC project)

Erasmus University

Status: Unknown

Conditions: Atopic Dermatitis

Treatments: Device: Binamed® silver based antimicrobial therapeutic clothing; Device: DermaCura® Chitosan based antimicrobial therapeutic clothing; Device: Binamed® therapeutic clothing without antimicrobial agents

Study type: Interventional

Funder types: Other

Identifiers

NCT04297215

Erasmus MC 108933

Details and patient eligibility

About

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.

Full 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.

Enrollment: 165 estimated patients

Sex: All

Ages: Under 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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165 participants in 3 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

This group will receive therapeutic clothing without antimicrobial agents

Treatment:

Device: Binamed® therapeutic clothing without antimicrobial agents

Chitosan group

Active Comparator group

Description:

This group will receive antimicrobial therapeutic clothing based on chitosan

Treatment:

Device: DermaCura® Chitosan based antimicrobial therapeutic clothing

Silver group

Active Comparator group

Description:

This group will receive antimicrobial clothing based on silver.

Treatment:

Device: Binamed® silver based antimicrobial therapeutic clothing