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 Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Device: DermaCura® Chitosan based antimicrobial therapeutic clothing
* Device: Binamed® silver based antimicrobial therapeutic clothing
* Device: Binamed® therapeutic clothing without antimicrobial agents


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br>This group will receive therapeutic clothing without antimicrobial agents | Device: Binamed® therapeutic clothing without antimicrobial agents<br>* The Binamed® therapeutic clothing without antimicriobial agents (BAP Medical) is therapeutic clothing made of micro-modal and lycra. Micro-madal is a semi-synthetic wood cellulose fiber. This fiber has a high strength hand elasticity, a high moisture-permeability and feels soft. Lycra ensures an optimal fit on the skin. The therapeutic clothing is to be worn at night during the 12-month intervention period and if needed during the day. Usual care including application of emollients, corticosteroid ointments or creams only if needed and/or antihistamines is continued, with standardized steroid ointments and treatment regimens for comparability purposes.<br>|
| Active Comparator: Chitosan group<br>This group will receive antimicrobial therapeutic clothing based on chitosan | Device: DermaCura® Chitosan based antimicrobial therapeutic clothing<br>* DermaCura® antimicrobial therapeutic clothing (D&M) consists of 98% TENCEL® and 2% elastane. 1% chitosan has been added to TENCEL® The therapeutic clothing is to be worn at night during the 12-month intervention period and if needed during the day. Usual care including application of emollients, corticosteroid ointments or creams only if needed and/or antihistamines is continued, with standardized steroid ointments and treatment regimens for comparability purposes.<br>|
| Active Comparator: Silver group<br>This group will receive antimicrobial clothing based on silver. | Device: Binamed® silver based antimicrobial therapeutic clothing<br>* The Binamed® antimicrobial therapeutic clothing (BAP Medical) consists of micro-modal, lycra and woven silver filaments as antibacterial agent. The therapeutic clothing is to be worn at night during the 12-month intervention period and if needed during the day. Usual care including application of emollients, corticosteroid ointments or creams only if needed and/or antihistamines is continued, with standardized steroid ointments and treatment regimens for comparability purposes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Eczema Area and Severity Index (EASI) | 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 | Two weeks for baseline, baseline, 1 month, 3 months 6 months and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in global assessment of degree of impetiginisation | 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 | Baseline, 1 month, 3 months 6 months and 12 months | 
| Change in S. Aureus colonization | 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 | Baseline, 1 month, 3 months 6 months and 12 months | 
| Change in the Patient Oriented Eczema Measure (POEM) | 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. | Baseline, 1 month, 3 months 6 months and 12 months | 
| Change in Patient global assessment (PGA) of disease severity | 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. | Baseline, 1 month, 3 months 6 months and 12 months | 
| Change in the Dermatology Life Quality Index (DLQI) | 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. | Baseline, 1 month, 3 months 6 months and 12 months | 
| Change in the Child Dermatology Life Quality Index (CDLQI) | 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. | Baseline, 1 month, 3 months 6 months and 12 months | 
| Change in the Infant Dermatology Life Quality Index (IDLQI) | 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. | Baseline, 1 month, 3 months 6 months and 12 months | 
| Change on the visual analogue scale (0-100 mm) for itch (VAS for itch) | 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. | Baseline, 1 month, 3 months 6 months and 12 months | 
| Change on the visual analogue scale (0-100 mm) for sleep disturbance (VAS for sleep disturbance) | 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. | Baseline, 1 month, 3 months 6 months and 12 months | 
| Change on the visual analogue scale (0-100 mm) for pain (VAS for pain) | 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. | Baseline, 1 month, 3 months 6 months and 12 months | 
| Use emollients | 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. | Through study completion, 1 year | 
| Use of antibiotics | 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. | Through study completion, 1 year | 
| Use of topical corticosteroids | 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. | Through study completion, 1 year | 
| Use of therapeutic clothing | 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. | Through study completion, 1 year | 
| Quality-adjusted life year | 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. | Baseline, 1 month, 3 months 6 months and 12 months | 
| Recap of atopic eczema (RECAP) - a standardized questionnaire that measures (long term) AD control | 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. | Baseline, 1 month, 3 months, 6 months and 12 months | 
| Dermatitis Family Impact (DFI) - a standardized questionnaire that measures the impact of a skin disease on the family of the patient | 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. | Baseline, 3 months, 6 months and 12 months | 
| Family Dermatology Life Quality (FDLQI) - a standardized questionnaire that measures the impact of a skin disease on family members | 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. | Baseline, 3 months, 6 months and 12 months | 
| Parenting Stress Questionnaire | 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 | Baseline, 3 months, 6 months and 12 months | 
| Quality of life (measured by the TAPCOL) | 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. | Baseline, 3 months, 6 months and 12 months | 
| Quality of life (measured by the TACQOL ) | 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) | Baseline, 3 months, 6 months and 12 months | 
| Quality of life (measured by the TAAQOL ) | 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. | Baseline, 3 months, 6 months and 12 months | 
| Change of silver excretion in urine | Difference in urinary silver excretion over time. Measured in the silver group only. | Baseline, 1month, 3 months, 6 months and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atopic dermatitis, Staphylococcus aureus, Therapeutical clothing, Anti-infective agents