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…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess the effectiveness of antibacterial clothing based on silver or
chitosan on the doctor-reported AD severity (Eczema Area and Severity Index,
EASI) in patients with moderate to severe AD.
Secondary outcome
To evaluate the effect of antimicrobial clothing based on silver or chitosan in
patients with AD on:
Disease severity measured by the
- Patient Oriented Eczema Measure (POEM) or POEM for proxy completion in case
of children up to 10 years of age by parents;
- Degree of itching (VAS);
- Degree of sleep disturbance (VAS);
- Degree of infection.
- IGA (investigator Global Assessment)
- RECAP
Amount and potency of topical corticosteroid use;
Use of emollients and antibiotics;
S. aureus colonization;
Quality of life measured by the
- Infants Dermatology Life Quality Index (IDLQI), Children's Dermatology Life
Quality Index (CDLQI) < 16 years of age. Dermatology Life Quality Index (DLQI)
* 16 years of age, Family Dermatology Life Quality Index (FDLQI) and Dermatitis
Family Impact (DFI)
- Euroqol questionnaire.
- TAPQOL,TACQOL, TAAQOL
Adherence and Satisfaction regarding the clothing
Silver excretion in urine
Background summary
Atopic dermatitis (AD) is a chronic inflammatory skin disease that affects 10%
to 20% of children and between 2% and 15% of the adults in Western Europe.
Since 2000 therapeutic clothing or functional textiles based on silver or
chitosan as antibacterial agents were introduced as therapeutics of 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.Therapeutic clothing has been used for decades as part of AD
treatment. Historically, cotton bandages were used to cover the affected skin.
This provides a fixation of creams and ointments, thereby possibly enhancing
their action. It also protects the skin from further damage through scratching
and irritating factors (Ring 2012). Since 2000 therapeutic clothing or
functional textiles based on silver or chitosan as antibacterial agents were
introduced. 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. The antimicrobial effects of silver and chitosan have been
demonstrated before.
Study objective
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 design
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.
Intervention
Patients are randomized into one of three intervention groups. Group A will
receive therapeutic clothing without antimicrobial agents (control group),
group B will receive antimicrobial therapeutic clothing based on chitosan, and
group C will receive antimicrobial clothing based on silver. All therapeutic
clothing is to be worn at night most times during the 12-month intervention
period. It is also possible to wear the clothing during the day if necessary.
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.
Study burden and risks
No risks expected
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
- AD diagnosed according to the criteria of Williams (Williams 1994);
- Age: 0 - 80 years;
- AD 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 appointments.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL67981.078.18 |