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

Atopic Dermatitis Clinical Trial

— ABC project  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04297215
• Other study ID #: Erasmus MC 108933
• Status: Recruiting
• Phase: N/A
• Start date: March 17, 2020
• Est. completion date: January 1, 2023

Study information

• Verified date: July 2020
• Source: Erasmus Medical Center
• Contact: Suzanne G.M.A. Pasmans, Prof
• Phone: +31 6 53524299
• Email: s.pasmans[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 165
• Est. completion date: January 1, 2023
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Device:
• DermaCura® Chitosan based antimicrobial therapeutic clothing
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.
• Binamed® silver based antimicrobial therapeutic clothing
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.
• Binamed® therapeutic clothing without antimicrobial agents
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.

Locations

Country	Name	City	State
Netherlands	Erasmus University Medical Center	Rotterdam	Zuid-Holland

Sponsors (9)

Lead Sponsor	Collaborator
Erasmus Medical Center	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), BAP Medical, D&M B.V., DeclaCare, St. Antonius Hospital, UMC Utrecht, University Medical Center Groningen, ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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