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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-17

Study Completion Date

2023-01-01

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.

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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.

Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control group

This group will receive therapeutic clothing without antimicrobial agents

Group Type PLACEBO_COMPARATOR

Binamed® therapeutic clothing without antimicrobial agents

Intervention Type 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.

Chitosan group

This group will receive antimicrobial therapeutic clothing based on chitosan

Group Type ACTIVE_COMPARATOR

DermaCura® Chitosan based antimicrobial therapeutic clothing

Intervention Type 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.

Silver group

This group will receive antimicrobial clothing based on silver.

Group Type ACTIVE_COMPARATOR

Binamed® silver based antimicrobial therapeutic clothing

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

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

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No