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

Not Applicable

• Conditions: Atopic Dermatitis
• Interventions: Device: Binamed® therapeutic clothing without antimicrobial agents; Device: DermaCura® Chitosan based antimicrobial therapeutic clothing; Device: Binamed® silver based antimicrobial therapeutic clothing

• Registration Number: NCT04297215
• Lead Sponsor: Erasmus Medical Center

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.

Study Timeline

• Study First Submitted: 2019-09-04
• Study First Submitted QC: 2020-03-03
• Study First Posted: 2020-03-05
• Study Start: 2020-03-17
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-21
• Last Update Posted: 2020-07-22
• Primary Completion: 2022-10-01
• Study Completion: 2023-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 165

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Binamed® therapeutic clothing without antimicrobial agents	This group will receive therapeutic clothing without antimicrobial agents
Chitosan group	DermaCura® Chitosan based antimicrobial therapeutic clothing	This group will receive antimicrobial therapeutic clothing based on chitosan
Silver group	Binamed® silver based antimicrobial therapeutic clothing	This group will receive antimicrobial clothing based on silver.

Primary Outcome Measures

Name	Time	Method
Change in the Eczema Area and Severity Index (EASI)	Two weeks for baseline, baseline, 1 month, 3 months 6 months and 12 months	Change in disease severity measured by the EASI between the clothing without antimicrobial agents (control group) and microbial growth reducing/ antimicrobial clothing based on chitosan or silver (intervention groups) over 12 months. Minimum score is 0, maximum score is 72. A higher score indicates more sever eczema

Secondary Outcome Measures

Name	Time	Method
Change in the Patient Oriented Eczema Measure (POEM)	Baseline, 1 month, 3 months 6 months and 12 months	Change 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 months. The POEM is a validated and standardized patient questionnaire.
Change in the Dermatology Life Quality Index (DLQI)	Baseline, 1 month, 3 months 6 months and 12 months	Change in DLQI between the clothing without antimicrobial agents (control group) and microbial growth reducing/ antimicrobial clothing based on chitosan or silver (intervention groups) over 12 months. Minimum score is 0, maximum score is 30. A higher score indicates more impact on quality of life. This outcome measure is assessed in patient \>16 years old. The DLQI is a validated and standardized patient questionnaire.
Change on the visual analogue scale (0-100 mm) for pain (VAS for pain)	Baseline, 1 month, 3 months 6 months and 12 months	Difference in degree of pain, expressed on a VAS (0-100 mm), between the clothing without antimicrobial agents (control group) and microbial growth reducing/ antimicrobial clothing based on chitosan or silver (intervention groups) over 12 months. Minimum score is 0, maximum score is 100mm. A higher score indicates more pain.
Change in the Infant Dermatology Life Quality Index (IDLQI)	Baseline, 1 month, 3 months 6 months and 12 months	Change in IDLQI between the clothing without antimicrobial agents (control group) and microbial growth reducing/ antimicrobial clothing based on chitosan or silver (intervention groups) over 12 months. Minimum score is 0, maximum score is 30. A higher score indicates more impact on quality of life. his outcome measure is assessed in patient \<4 years old. The IDLQI is a validated and standardized patient questionnaire.
Use emollients	Through study completion, 1 year	Difference in emollients use between the clothing without antimicrobial agents (control group) and microbial growth reducing/ antimicrobial clothing based on chitosan or silver (intervention groups) is assessed weekly over 12 months. A patient questionnaire with two items (daily application frequency and number of days per week) will be used to assess this outcome.
Use of antibiotics	Through study completion, 1 year	Difference in total use of antibiotics between the clothing without antimicrobial agents (control group) and microbial growth reducing/ antimicrobial clothing based on chitosan or silver (intervention groups) is assessed over 12 months. A weekly patient questionnaire with two items (dose and number of days) will be used to assess this outcome.
Change in the Child Dermatology Life Quality Index (CDLQI)	Baseline, 1 month, 3 months 6 months and 12 months	Change in CDLQI between the clothing without antimicrobial agents (control group) and microbial growth reducing/ antimicrobial clothing based on chitosan or silver (intervention groups) over 12 months. Minimum score is 0, maximum score is 30. A higher score indicates more impact on quality of life. This outcome measure is assessed in patient 4-16 years old. The CDLQI is a validated and standardized patient questionnaire.
Dermatitis Family Impact (DFI) - a standardized questionnaire that measures the impact of a skin disease on the family of the patient	Baseline, 3 months, 6 months and 12 months	Change in DFI on the family of the patient between the clothing without antimicrobial agents (control group) and microbial growth reducing/ antimicrobial clothing based on chitosan or silver (intervention groups) over 12 months. (only in patients \<18 years). The minimum DFI score is 0 (= no impact on life of family). The maximum DFI score is 30 (= maximum effect on life of family). The DFI is a standerized patient questionnaire.
Family Dermatology Life Quality (FDLQI) - a standardized questionnaire that measures the impact of a skin disease on family members	Baseline, 3 months, 6 months and 12 months	Change in FDLQI between the clothing without antimicrobial agents (control group) and microbial growth reducing/ antimicrobial clothing based on chitosan or silver (intervention groups) over 12 months. (by parents in patients \<18 years, by partner in patients \>18 years. This questionnaire assesses impairement of the quality of life of adult family members. A higher score indicates more impairment.
Quality of life (measured by the TAPCOL)	Baseline, 3 months, 6 months and 12 months	Difference in quality of life between the clothing without antimicrobial agents (control group) and microbial growth reducing/ antimicrobial clothing based on chitosan or silver (intervention groups) over 12 months. The TAPCOL is validated and standardized questionnaire for children 6\< years.
Quality of life (measured by the TAAQOL )	Baseline, 3 months, 6 months and 12 months	Difference in quality of life between the clothing without antimicrobial agents (control group) and microbial growth reducing/ antimicrobial clothing based on chitosan or silver (intervention groups) over 12 months. The TAAQOL is a validated and standardized patient questionnaire for patients older than 16 years old.
Change in global assessment of degree of impetiginisation	Baseline, 1 month, 3 months 6 months and 12 months	Change 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
Change in Patient global assessment (PGA) of disease severity	Baseline, 1 month, 3 months 6 months and 12 months	Change in PGA severity of the disease between the clothing without antimicrobial agents (control group) and microbial growth reducing/ antimicrobial clothing based on chitosan or silver (intervention groups) over 12 months. This is a standardized patient questionnaire. The minimum score is 0, the maximum score is 4.
Change in S. Aureus colonization	Baseline, 1 month, 3 months 6 months and 12 months	Change in S. aureus colonization between the clothing without antimicrobial agents (control group) and microbial growth reducing/ antimicrobial clothing based on chitosan or silver (intervention groups) over 12 months
Change on the visual analogue scale (0-100 mm) for itch (VAS for itch)	Baseline, 1 month, 3 months 6 months and 12 months	Change in degree of itching, expressed on a visual analogue scale (0-100 mm), between the clothing without antimicrobial agents (control group) and microbial growth reducing/ antimicrobial clothing based on chitosan or silver (intervention groups) over 12 months. Minimum score is 0, maximum score is 100mm. A higher score indicates more itch.
Quality of life (measured by the TACQOL )	Baseline, 3 months, 6 months and 12 months	Difference in quality of life between the clothing without antimicrobial agents (control group) and microbial growth reducing/ antimicrobial clothing based on chitosan or silver (intervention groups) over 12 months. The TAPQOL is a validated and standardized patient questionnaire for children (\>5 years, \<16 years)
Change of silver excretion in urine	Baseline, 1month, 3 months, 6 months and 12 months	Difference in urinary silver excretion over time. Measured in the silver group only.
Change on the visual analogue scale (0-100 mm) for sleep disturbance (VAS for sleep disturbance)	Baseline, 1 month, 3 months 6 months and 12 months	Change in degree of sleep disturbance, expressed on a VAS (0-100 mm), between the clothing without antimicrobial agents (control group) and microbial growth reducing/ antimicrobial clothing based on chitosan or silver (intervention groups) over 12 months. Minimum score is 0, maximum score is 100mm. A higher score indicates more sleep disturbance.
Use of topical corticosteroids	Through study completion, 1 year	Difference in topical corticosteroid use between the clothing without antimicrobial agents (control group) and microbial growth reducing/ antimicrobial clothing based on chitosan or silver (intervention groups) is assessed over 12 months. A weekly patient questionnaire with two items (application frequency and number of days) will be used to assess this outcome.
Use of therapeutic clothing	Through study completion, 1 year	Difference in therapeutic clothing use between the clothing without antimicrobial agents (control group) and microbial growth reducing/ antimicrobial clothing based on chitosan or silver (intervention groups) is assessed over 12 months. A weekly patient questionnaires with two items (number of nights worn and number of days worn) will be used to assess this outcome.
Quality-adjusted life year	Baseline, 1 month, 3 months 6 months and 12 months	Difference in the QALYs based on EuroQol questionnaire between the clothing without antimicrobial agents (control group) and microbial growth reducing/ antimicrobial clothing based on chitosan or silver (intervention groups) over 12 months.
Recap of atopic eczema (RECAP) - a standardized questionnaire that measures (long term) AD control	Baseline, 1 month, 3 months, 6 months and 12 months	Change in RECAP between the clothing without antimicrobial agents (control group) and microbial growth reducing/ antimicrobial clothing based on chitosan or silver (intervention groups) over 12 months. RECAP is an standardized instrument (patient questionnaire) with 10 items to measure (long-term) eczema control.
Parenting Stress Questionnaire	Baseline, 3 months, 6 months and 12 months	Difference in parenting stress between the clothing without antimicrobial agents (control group) and microbial growth reducing/ antimicrobial clothing based on chitosan or silver (intervention groups) over 12 months. (Only in patients \<18 years old). A T-score \< 60 can be seen as normal, a higher score implicates clinical problems. The parenting stress questionnaire is a validated and standardized questionnaire

Trial Locations

Locations (1)

Erasmus University Medical Center; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands