TY - JOUR
T1 - The effectiveness of antibacterial therapeutic clothing compared with non-antibacterial therapeutic clothing in patients with moderate-to-severe atopic dermatitis
T2 - A randomized controlled, observer-blind pragmatic trial (ABC trial)
AU - Ragamin, Aviël
AU - Schappin, Renske
AU - de Graaf, Marlies
AU - Tupker, Ron A
AU - Fieten, Karin B
AU - van Mierlo, Minke M F
AU - Bronner, Madelon B
AU - Romeijn, Geertruida L E
AU - Sloot, Manon M
AU - Boesjes, Celeste M
AU - van der Rijst, Lisa
AU - Arents, Bernd W M
AU - Rustemeyer, Thomas
AU - Schuttelaar, Marie L A
AU - Pasmans, Suzanne G M A
N1 - © The Author(s) 2023. Published by Oxford University Press on behalf of British Association of Dermatologists.
PY - 2023/11/4
Y1 - 2023/11/4
N2 - BACKGROUND: Increased Staphylococcus aureus (SA) colonization is considered an important factor in the pathogenesis of atopic dermatitis (AD). Antibacterial therapeutic clothing aims to reduce SA colonization and AD inflammation, however its role in the management of AD remains poorly understood.OBJECTIVE: To investigate the effectiveness of antibacterial therapeutic clothing plus standard topical treatment in patients with moderate-to-severe AD, compared to standard therapeutic clothing plus standard topical treatment. If effectiveness is demonstrated, the cost-effectiveness will be evaluated.METHODS: A pragmatic, double-blinded, multicenter, randomized, controlled, trial (NCT04297215) was conducted in patients of all ages with moderate-to-severe AD. Patients were centrally randomized 1:1:1 to receive standard therapeutic clothing, antibacterial clothing based on chitosan or silver. The primary outcome was the between-group difference in Eczema Area and Severity Index (EASI) measured over 52 weeks. Secondary outcomes included patient-reported outcomes, topical corticosteroid use, SA colonization, safety, and cost-effectiveness. Outcomes were assessed by means of (generalized) linear mixed model analyses.RESULTS: Between March 16, 2020, and December 20, 2021, 171 patients were enrolled. In the analyses 159 patients were included (n=54 in the standard therapeutic clothing group, n=50 in the chitosan group and n=55 in the silver group). Adherence was high (median: 7 nights/week, IQR: 3-7). Median EASI scores at baseline, 4, 12, 26 and 52 weeks were in the standard therapeutic clothing group 11.8, 4.3, 4.6, 4.2, 3.6 compared to 11.3, 5.0, 3.0, 3.0, 4.4 in the chitosan and 11.6, 5.0, 5.4, 4.6 and 5.8 in the silver group. No differences in EASI over 52 weeks between the standard therapeutic clothing, chitosan (-0.1, 95%CI: -0.3 to 0.2, p=0.53), and silver group (-0.1, 95%CI: -0.3 to 0.2, p=0.58) were found. However, a small significant (P=0.035) group-by-time interaction effect between the standard and silver group was found, in which the silver group performed worse after 26 weeks. No differences between groups were found in patient-reported outcomes, topical corticosteroid use, SA skin colonization, and healthcare utilization. No severe adverse events or silver absorption were observed.CONCLUSIONS: The results of this study suggest no additional benefits of antibacterial agents in therapeutic clothing in patients with moderate-to-severe AD.
AB - BACKGROUND: Increased Staphylococcus aureus (SA) colonization is considered an important factor in the pathogenesis of atopic dermatitis (AD). Antibacterial therapeutic clothing aims to reduce SA colonization and AD inflammation, however its role in the management of AD remains poorly understood.OBJECTIVE: To investigate the effectiveness of antibacterial therapeutic clothing plus standard topical treatment in patients with moderate-to-severe AD, compared to standard therapeutic clothing plus standard topical treatment. If effectiveness is demonstrated, the cost-effectiveness will be evaluated.METHODS: A pragmatic, double-blinded, multicenter, randomized, controlled, trial (NCT04297215) was conducted in patients of all ages with moderate-to-severe AD. Patients were centrally randomized 1:1:1 to receive standard therapeutic clothing, antibacterial clothing based on chitosan or silver. The primary outcome was the between-group difference in Eczema Area and Severity Index (EASI) measured over 52 weeks. Secondary outcomes included patient-reported outcomes, topical corticosteroid use, SA colonization, safety, and cost-effectiveness. Outcomes were assessed by means of (generalized) linear mixed model analyses.RESULTS: Between March 16, 2020, and December 20, 2021, 171 patients were enrolled. In the analyses 159 patients were included (n=54 in the standard therapeutic clothing group, n=50 in the chitosan group and n=55 in the silver group). Adherence was high (median: 7 nights/week, IQR: 3-7). Median EASI scores at baseline, 4, 12, 26 and 52 weeks were in the standard therapeutic clothing group 11.8, 4.3, 4.6, 4.2, 3.6 compared to 11.3, 5.0, 3.0, 3.0, 4.4 in the chitosan and 11.6, 5.0, 5.4, 4.6 and 5.8 in the silver group. No differences in EASI over 52 weeks between the standard therapeutic clothing, chitosan (-0.1, 95%CI: -0.3 to 0.2, p=0.53), and silver group (-0.1, 95%CI: -0.3 to 0.2, p=0.58) were found. However, a small significant (P=0.035) group-by-time interaction effect between the standard and silver group was found, in which the silver group performed worse after 26 weeks. No differences between groups were found in patient-reported outcomes, topical corticosteroid use, SA skin colonization, and healthcare utilization. No severe adverse events or silver absorption were observed.CONCLUSIONS: The results of this study suggest no additional benefits of antibacterial agents in therapeutic clothing in patients with moderate-to-severe AD.
U2 - https://doi.org/10.1093/bjd/ljad437
DO - https://doi.org/10.1093/bjd/ljad437
M3 - Article
C2 - 37936331
SN - 0007-0963
JO - British Journal of Dermatology
JF - British Journal of Dermatology
ER -