Atopic DermatitisABC projectNCT04297215
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
A study testing DermaCura® Chitosan based antimicrobial therapeutic clothing, Binamed® silver based antimicrobial therapeutic clothing and Binamed® therapeutic clothing without antimicrobial agents in people with Atopic Dermatitis, run by Erasmus Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- DermaCura® Chitosan based antimicrobial therapeutic clothing, Binamed® silver based antimicrobial therapeutic clothing and Binamed® therapeutic clothing without antimicrobial agents
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Mar 2020to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Atopic dermatitis diagnosed according to the criteria of Williams (Williams 1994)
- Atopic dermatitis severity according to EASI at t = 0: > 6.0.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus University Medical Center
Rotterdam, South Holland, 3015GD
Suzanne G.M.A. Pasmans, MD, PhD, Prof, s.pasmans@erasmusmc.nl
Aviël Ragamin, MD, abcstudie@erasmusmc.nl
About this study
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
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.
Read the 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.
- Conditions
- Atopic Dermatitis
- Being tested
- DermaCura® Chitosan based antimicrobial therapeutic clothing, Binamed® silver based antimicrobial therapeutic clothing, Binamed® therapeutic clothing without antimicrobial agents
- Keywords
- Atopic dermatitis, Staphylococcus aureus, Therapeutical clothing, Anti-infective agents
- Medical subject headings
- Dermatitis, Atopic, Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DermaCura® Chitosan based antimicrobial therapeutic clothingDevice
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 clothingDevice
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 agentsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | This group will receive therapeutic clothing without antimicrobial agents Receives: Device: Binamed® therapeutic clothing without antimicrobial agents |
| Chitosan group | Active comparator | This group will receive antimicrobial therapeutic clothing based on chitosan Receives: Device: DermaCura® Chitosan based antimicrobial therapeutic clothing |
| Silver group | Active comparator | This group will receive antimicrobial clothing based on silver. Receives: Device: Binamed® silver based antimicrobial therapeutic clothing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: Baseline, 1 month, 3 months 6 months and 12 months
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
Measured: Baseline, 1 month, 3 months 6 months and 12 months
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.
Measured: Baseline, 1 month, 3 months 6 months and 12 months
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.
Measured: Baseline, 1 month, 3 months 6 months and 12 months
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.
Measured: Baseline, 1 month, 3 months 6 months and 12 months
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.
Measured: Baseline, 1 month, 3 months 6 months and 12 months
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.
Measured: Baseline, 1 month, 3 months 6 months and 12 months
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.
Measured: 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)
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.
Measured: Baseline, 1 month, 3 months 6 months and 12 months
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.
Measured: Baseline, 1 month, 3 months 6 months and 12 months
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.
Measured: Through study completion, 1 year
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.
Measured: Through study completion, 1 year
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.
Measured: Through study completion, 1 year
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.
Measured: Through study completion, 1 year
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.
Measured: Baseline, 1 month, 3 months 6 months and 12 months
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline, 3 months, 6 months and 12 months
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
Measured: Baseline, 3 months, 6 months and 12 months
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.
Measured: Baseline, 3 months, 6 months and 12 months
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)
Measured: Baseline, 3 months, 6 months and 12 months
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.
Measured: Baseline, 3 months, 6 months and 12 months
Change of silver excretion in urine
Difference in urinary silver excretion over time. Measured in the silver group only.
Measured: Baseline, 1month, 3 months, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start17 Mar 2020
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), UMC Utrecht, St. Antonius Hospital, ZonMw: The Netherlands Organisation for Health Research and Development, BAP Medical, D&M B.V., DeclaCare, University Medical Center Groningen
- Responsible party
- Principal investigator, Suzanne G.M.A. Pasmans, Erasmus Medical Center
- Investigators
- Suzanne G.M.A Pasmans, Prof, Principal investigator, Erasmus MC University Medical Center Rotterdam Dept Dermatology, Center of Paedatric Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04297215
- Sponsor's protocol ID
- Erasmus MC 108933
- Acronym
- ABC project
- Status last verified
- Jul 2020
- First submitted
- 4 Sep 2019
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34895292
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04297215
- Acronym / sponsor ID
- ABC project / Erasmus MC 108933
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic dermatitis, Staphylococcus aureus, Therapeutical clothing, Anti-infective agents
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), UMC Utrecht, St. Antonius Hospital, ZonMw: The Netherlands Organisation for Health Research and Development, BAP Medical, D&M B.V., DeclaCare, University Medical Center Groningen
- Study start
- 17 Mar 2020 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 5 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Device: Binamed® therapeutic clothing without antimicrobial agentsThis group will receive therapeutic clothing without antimicrobial agents |
| Chitosan group | Active comparator | Device: DermaCura® Chitosan based antimicrobial therapeutic clothingThis group will receive antimicrobial therapeutic clothing based on chitosan |
| Silver group | Active comparator | Device: Binamed® silver based antimicrobial therapeutic clothingThis group will receive antimicrobial clothing based on silver. |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Atopic dermatitis diagnosed according to the criteria of Williams (Williams 1994)
- Atopic dermatitis severity according to EASI at t = 0: > 6.0.
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DermaCura® Chitosan based antimicrobial therapeutic clothingDermaCura® 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. | Device | Chitosan group |
| Binamed® silver based antimicrobial therapeutic clothingThe 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. | Device | Silver group |
| Binamed® therapeutic clothing without antimicrobial agentsThe 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. | Device | Control group |
Primary outcome
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
23 secondary outcomes
Change in global assessment of degree of impetiginisation
Time frame: 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 the Patient Oriented Eczema Measure (POEM)
Time frame: 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 the Dermatology Life Quality Index (DLQI)
Time frame: 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 the Infant Dermatology Life Quality Index (IDLQI)
Time frame: 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 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 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
Use emollients
Time frame: Through study completion, 1 year
Use of antibiotics
Time frame: Through study completion, 1 year
Use of topical corticosteroids
Time frame: Through study completion, 1 year
Use of therapeutic clothing
Time frame: Through study completion, 1 year
Quality-adjusted life year
Time frame: 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
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
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
Parenting Stress Questionnaire
Time frame: 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
Quality of life (measured by the TACQOL )
Time frame: 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
Change of silver excretion in urine
Time frame: Baseline, 1month, 3 months, 6 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Derived from this study: PubMed 34895292Ragamin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne G.M.A Pasmans, Prof principal investigator
Erasmus MC University Medical Center Rotterdam Dept Dermatology, Center of Paedatric Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DermaCura® Chitosan based antimicrobial therapeutic clothing, Binamed® silver based antimicrobial therapeutic clothing and Binamed® therapeutic clothing without antimicrobial agents in people with Atopic Dermatitis, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suzanne G.M.A. Pasmans, Prof (+31 6 53524299, s.pasmans@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04297215, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020.