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 project)

July 21, 2020 updated by: Suzanne G.M.A. Pasmans, Erasmus Medical Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

165

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Netherlands, 3015GD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group
This group will receive therapeutic clothing without antimicrobial agents
Device: 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.
Active Comparator: Chitosan group
This group will receive antimicrobial therapeutic clothing based on chitosan
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.
Active Comparator: Silver group
This group will receive antimicrobial clothing based on silver.
Device: 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasmus Medical Center

Collaborators

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

Investigators

  • Principal Investigator: Suzanne G.M.A Pasmans, Prof, Erasmus MC University Medical Center Rotterdam Dept Dermatology, Center of Paedatric Dermatology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2020

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

September 4, 2019

First Submitted That Met QC Criteria

March 3, 2020

First Posted (Actual)

March 5, 2020

Study Record Updates

Last Update Posted (Actual)

July 22, 2020

Last Update Submitted That Met QC Criteria

July 21, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Erasmus MC 108933

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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