Pragmatic randomized controlled multi center trial comparing 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 (AD)

Pragmatic randomized controlled multi center trial comparing 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 (AD) - ABC study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55834

Enrollment

165

Registered

2019-04-18

Start date

2020-03-17

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic dermatitis eczema

Interventions

Patients are randomized into one of three intervention groups. Group A will receive therapeutic clothing without antimicrobial agents (control group), group B will receive antimicrobial therapeutic

Eligibility

Age

2 Years to 99 Years

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 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
To assess the effectiveness of antibacterial clothing based on silver or chitosan on the doctor-reported AD severity (Eczema Area and Severity Index, EASI) in patients with moderate to severe AD.	—

Secondary

Measure	Time frame
To evaluate the effect of antimicrobial clothing based on silver or chitosan in patients with AD on: Disease severity measured by the - Patient Oriented Eczema Measure (POEM) or POEM for proxy completion in case of children up to 10 years of age by parents; - Degree of itching (VAS); - Degree of sleep disturbance (VAS); - Degree of infection. - IGA (investigator Global Assessment) - RECAP Amount and potency of topical corticosteroid use; Use of emollients and antibiotics; S. aureus colonization; Quality of life measured by the - Infants Dermatology Life Quality Index (IDLQI), Children's Dermatology Life Quality Index (CDLQI)	—

Measure

Time frame

To evaluate the effect of antimicrobial clothing based on silver or chitosan in patients with AD on: Disease severity measured by the - Patient Oriented Eczema Measure (POEM) or POEM for proxy completion in case of children up to 10 years of age by parents; - Degree of itching (VAS); - Degree of sleep disturbance (VAS); - Degree of infection. - IGA (investigator Global Assessment) - RECAP Amount and potency of topical corticosteroid use; Use of emollients and antibiotics; S. aureus colonization; Quality of life measured by the - Infants Dermatology Life Quality Index (IDLQI), Children's Dermatology Life Quality Index (CDLQI)

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)