Status:
UNKNOWN
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
Lead Sponsor:
Erasmus Medical Center
Collaborating Sponsors:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
UMC Utrecht
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
Up to 80 years
Phase:
NA
Brief 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 co...
Detailed 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...
Eligibility Criteria
Inclusion
- Atopic dermatitis diagnosed according to the criteria of Williams (Williams 1994)
- Atopic dermatitis severity according to EASI at t = 0: \> 6.0.
Exclusion
- 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
Key Trial Info
Start Date :
March 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2023
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT04297215
Start Date
March 17 2020
End Date
January 1 2023
Last Update
July 22 2020
Active Locations (1)
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1
Erasmus University Medical Center
Rotterdam, South Holland, Netherlands, 3015GD