Clinical trial NCT04297215: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atopic Dermatitis
Keywords: Atopic dermatitis
Staphylococcus aureus
Therapeutical clothing
Anti-infective agents
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: UMC Utrecht
name: St. Antonius Hospital
name: ZonMw: The Netherlands Organisation for Health Research and Development
name: BAP Medical
name: D&M B.V.
name: DeclaCare
name: University Medical Center Groningen
First posted: 2020-03-05
Enrollment: 165
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 clothing based on chitosan or antimicrobial clothing based on silver for 12 months.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the Eczema Area and Severity Index (EASI)
timeFrame: Two weeks for baseline, baseline, 1 month, 3 months 6 months and 12 months
Secondary outcomes:
measure: Change in global assessment of degree of impetiginisation
timeFrame: Baseline, 1 month, 3 months 6 months and 12 months
measure: Change in S. Aureus colonization
timeFrame: Baseline, 1 month, 3 months 6 months and 12 months
measure: Change in the Patient Oriented Eczema Measure (POEM)
timeFrame: Baseline, 1 month, 3 months 6 months and 12 months
measure: Change in Patient global assessment (PGA) of disease severity
timeFrame: Baseline, 1 month, 3 months 6 months and 12 months
measure: Change in the Dermatology Life Quality Index (DLQI)
timeFrame: Baseline, 1 month, 3 months 6 months and 12 months
measure: Change in the Child Dermatology Life Quality Index (CDLQI)
timeFrame: Baseline, 1 month, 3 months 6 months and 12 months
measure: Change in the Infant Dermatology Life Quality Index (IDLQI)
timeFrame: Baseline, 1 month, 3 months 6 months and 12 months
measure: Change on the visual analogue scale (0-100 mm) for itch (VAS for itch)
timeFrame: Baseline, 1 month, 3 months 6 months and 12 months
measure: Change on the visual analogue scale (0-100 mm) for sleep disturbance (VAS for sleep disturbance)
timeFrame: Baseline, 1 month, 3 months 6 months and 12 months
measure: Change on the visual analogue scale (0-100 mm) for pain (VAS for pain)
timeFrame: Baseline, 1 month, 3 months 6 months and 12 months
measure: Use emollients
timeFrame: Through study completion, 1 year
measure: Use of antibiotics
timeFrame: Through study completion, 1 year
measure: Use of topical corticosteroids
timeFrame: Through study completion, 1 year
measure: Use of therapeutic clothing
timeFrame: Through study completion, 1 year
measure: Quality-adjusted life year
timeFrame: Baseline, 1 month, 3 months 6 months and 12 months
measure: Recap of atopic eczema (RECAP) - a standardized questionnaire that measures (long term) AD control
timeFrame: Baseline, 1 month, 3 months, 6 months and 12 months
measure: Dermatitis Family Impact (DFI) - a standardized questionnaire that measures the impact of a skin disease on the family of the patient
timeFrame: Baseline, 3 months, 6 months and 12 months
measure: Family Dermatology Life Quality (FDLQI) - a standardized questionnaire that measures the impact of a skin disease on family members
timeFrame: Baseline, 3 months, 6 months and 12 months
measure: Parenting Stress Questionnaire
timeFrame: Baseline, 3 months, 6 months and 12 months
measure: Quality of life (measured by the TAPCOL)
timeFrame: Baseline, 3 months, 6 months and 12 months
measure: Quality of life (measured by the TACQOL )
timeFrame: Baseline, 3 months, 6 months and 12 months
measure: Quality of life (measured by the TAAQOL )
timeFrame: Baseline, 3 months, 6 months and 12 months
measure: Change of silver excretion in urine
timeFrame: Baseline, 1month, 3 months, 6 months and 12 months
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center
state: Zuid-Holland
Study officials:
affiliation: Erasmus MC University Medical Center Rotterdam Dept Dermatology, Center of Paedatric Dermatology
name: Suzanne G.M.A Pasmans, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ragamin A, Fieten KB, Tupker RA, de Wit J, van Mierlo MMF, Jansen MS, Bronner MB, Schappin R, Schuren FHJ, Romeijn MLE, Arents BWM, Polinder S, de Graaf M, Rustemeyer T, Schuttelaar MLA, Pasmans SGMA. 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 trial): study protocol for a pragmatic randomized controlled trial. Trials. 2021 Dec 11;22(1):902. doi: 10.1186/s13063-021-05836-y.