scholarly journals 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 ◽  
Vol 22 (1) ◽  
Author(s):  
Aviël Ragamin ◽  
Karin B. Fieten ◽  
Ron A. Tupker ◽  
Jill de Wit ◽  
Minke M. F. van Mierlo ◽  
...  
Keyword(s):  
Atopic Dermatitis ◽  
Cost Effectiveness ◽  
Antimicrobial Agents ◽  
Medical Center ◽  
Safety Data ◽  
Severe Atopic Dermatitis ◽  
Randomized Controlled ◽  
Functional Textiles ◽  
Patient Reported ◽  
Skin Colonization

Abstract Background 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 for AD. These agents aim to reduce skin colonization with Staphylococcus (S.) aureus. Increased colonization with S. aureus is correlated with increased AD severity. The antimicrobial effects of silver and chitosan have been demonstrated before. At this point, there is insufficient evidence for the effectiveness of antibacterial therapeutic clothing in patients with AD. Methods This is a pragmatic randomized controlled double-blind 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 AD. A total of 165 participants, aged 0 to 80, diagnosed with moderate to severe AD are included. The study is performed in the Erasmus MC University Medical Center, University Medical Center Groningen, University Medical Center Utrecht, Amsterdam University Medical Centers, and St. Antonius Hospital Nieuwegein. Patients will be randomized 1:1:1 into one of the three intervention groups: group A will receive therapeutic clothing without antimicrobial agents, group B will receive microbial growth reducing therapeutic clothing based on chitosan, and group C will receive antimicrobial clothing based on silver. All therapeutic clothing is to be worn at night during the 12-month intervention period. Usual care is continued. The primary objective is to assess the effectiveness of antibacterial clothing (silver and chitosan group) as compared to non-antibacterial clothing assessed with the Eczema Area and Severity Index at 12 months compared to baseline. Secondary outcomes include between-group differences in physician- and patient-reported outcome measures, topical therapy use, S. aureus skin colonization, and safety. Data will be collected at baseline and after 1 month, 3 months, 6 months, and 12 months. A cost-effectiveness analysis will be performed. Discussion This trial will provide data on the effectiveness, cost-effectiveness, and safety of antibacterial therapeutic clothing for patients with AD. Trial registration ClinicalTrials.gov NCT04297215. Registered on 5 March 2020

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

2021 ◽  
Author(s):  
Aviël Ragamin ◽  
Karin B. Fieten ◽  
Ron A. Tupker ◽  
Jill de Wit ◽  
Minke M.F. van Mierlo ◽  
...  
Keyword(s):  
Atopic Dermatitis ◽  
Cost Effectiveness ◽  
Antimicrobial Agents ◽  
Medical Center ◽  
Safety Data ◽  
Severe Atopic Dermatitis ◽  
Randomized Controlled ◽  
Functional Textiles ◽  
Patient Reported ◽  
Skin Colonization

Abstract Background: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 for AD. These agents aim to reduce skin colonization with Staphylococcus (S.) aureus. Increased colonization with S. aureus is correlated with increased AD severity. The antimicrobial effects of silver and chitosan have been demonstrated before. At this point there is insufficient evidence for the effectiveness of antibacterial therapeutic clothing in patients with AD.Methods: This is a pragmatic randomized controlled double-blind 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 AD. A total of 165 participants, aged 0 to 80, diagnosed with moderate to severe AD are included. The study is performed in the Erasmus MC University Medical Center, University Medical Center Groningen, University Medical Center Utrecht, Amsterdam University Medical Centers and St. Antonius Hospital Nieuwegein. Patients will be randomized 1:1:1 into one of the three intervention groups: Group A will receive therapeutic clothing without antimicrobial agents, group B will receive microbial growth reducing therapeutic clothing based on chitosan, and group C will receive antimicrobial clothing based on silver. All therapeutic clothing is to be worn at night during the 12-month intervention period. Usual care is continued. The primary objective is to assess the effectiveness of antibacterial clothing (silver and chitosan group) as compared to non-antibacterial clothing assessed with the Eczema Area and Severity Index at 12 months compared to baseline. Secondary outcomes include between-group differences in physician and patient-reported outcome measures, topical therapy use, S. aureus skin colonization, and safety. Data will be collected at baseline, after 1 month, 3 months, 6 months an at 12 months. A cost-effectiveness analysis will be performed.Discussion:This trial will provide data on the effectiveness, cost-effectiveness, and safety of antibacterial therapeutic clothing for patients with AD. Trial registration Clinicaltrials.gov, NCT04297215. Registered on 5 March 2020

scholarly journals Patient Reported Outcome Measure in Atopic Dermatitis Patients Treated with Dupilumab: 52-Weeks Results

2021 ◽  
Author(s):  
Servando E. Marron ◽  
Lucia Tomas-Aragones ◽  
Carlos A. Moncin-Torres ◽  
Manuel Gomez-Barrera ◽  
Francisco Javier Garcia-Latasa de Aranibar
Keyword(s):  
Quality Of Life ◽  
Atopic Dermatitis ◽  
Clinical Practice ◽  
Stressful Life Events ◽  
Severe Disease ◽  
Patient Reported Outcome ◽  
Routine Clinical Practice ◽  
Severe Atopic Dermatitis ◽  
Patient Reported

Dupilumab is used to treat atopic dermatitis patients who have proven to be refractory to previous treatments. The aim of this study was to assess evolution and patient reported outcome measures in adult patients with moderate-to-severe atopic dermatitis treated with Dupilumab in routine clinical practice. The outcomes were evaluated and registered at baseline and weeks-16, 40 and 52. The variables evaluated were: diseases severity, pruritus, stressful life events, difficulty to sleep, anxiety and depression, quality of life, satisfaction, adherence to the treatment, efficacy and safety. Eleven patients were recruited between Nov 14th 2017 and Jan 16th 2018. Demographic variables: 90% Caucasian, 82% women. Clinical variables: Mean duration of AD =17.7 (±12.8), 91% had severe disease severity. At baseline, SCORAD mean score = 61.7 (±15.5); itch was reported by 100% of patients; itch Visual Analogue Scale mean range of 8 (6-10); HADS mean total score =13.9 (±5.5); DLQI mean score =13.3 (±8.3): EQ-5D-3L mean range = 57 (30-99). At week-52 there is a significant reduction of SCORAD scores, HADS total score and improved quality of life. ¡This study confirms that Dupilumab, used for 52-weeks under routine clinical practice, maintains the improved atopic dermatitis signs and symptoms obtained at week-16, with a good safety profile.

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