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

NCT04297215 | Unknown DMC

• 1 other identifier: Erasmus MC 108933
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitis; Staphylococcus aureus; Therapeutical clothing; Anti-infective agents

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (23)

• Change in global assessment of degree of impetiginisation

  Baseline, 1 month, 3 months 6 months and 12 months

• Change in S. Aureus colonization

  Baseline, 1 month, 3 months 6 months and 12 months

• Change in the Patient Oriented Eczema Measure (POEM)

  Baseline, 1 month, 3 months 6 months and 12 months

• Change in Patient global assessment (PGA) of disease severity

  Baseline, 1 month, 3 months 6 months and 12 months

• Change in the Dermatology Life Quality Index (DLQI)

  Baseline, 1 month, 3 months 6 months and 12 months

Study Arms (3)

Control group

PLACEBO COMPARATOR

This group will receive therapeutic clothing without antimicrobial agents

Device: Binamed® therapeutic clothing without antimicrobial agents

Chitosan group

ACTIVE COMPARATOR

This group will receive antimicrobial therapeutic clothing based on chitosan

Device: DermaCura® Chitosan based antimicrobial therapeutic clothing

Silver group

ACTIVE COMPARATOR

This group will receive antimicrobial clothing based on silver.

Device: Binamed® silver based antimicrobial therapeutic clothing

Interventions

DermaCura® Chitosan based antimicrobial therapeutic clothing DEVICE

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.

Chitosan group

Binamed® silver based antimicrobial therapeutic clothing DEVICE

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.

Silver group

Binamed® therapeutic clothing without antimicrobial agents DEVICE

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.

Control group

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Atopic dermatitis diagnosed according to the criteria of Williams (Williams 1994)
• Atopic dermatitis severity according to EASI at t = 0: \> 6.0.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Erasmus University Medical Center

Rotterdam, South Holland, 3015GD, Netherlands

RECRUITING

Related Publications (1)

• 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.

  PMID: 34895292 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic; Staphylococcal Infections

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Suzanne G.M.A Pasmans, Prof

  Erasmus MC University Medical Center Rotterdam Dept Dermatology, Center of Paedatric Dermatology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suzanne G.M.A. Pasmans, Prof

CONTACT

+31 6 53524299; s.pasmans@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD, PhD Professor

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: March 5, 2020
• Study Start: March 17, 2020
• Primary Completion: October 1, 2022
• Study Completion: January 1, 2023
• Last Updated: July 22, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)