Atopic dermatitis
Conditions
Interventions
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
Sponsors
Erasmus MC
Eligibility
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| - 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 IDLQI18 years between the clothing without antimicrobial agents (control group) and microbial grow | — |
Contacts
Public ContactSuzanne Pasmans
ErasmusMC
Outcome results
None listed