A proposal for the use of new silver-seaweed-cotton fibers in the treatment of atopic dermatitis

Araújo, Catarina; Gomes, José Álvaro Pereira; Vieira, Ana Paula; Ventura, Filipa; Fernandes, José Carlos; Brito, Celeste

doi:10.3109/15569527.2013.775655

Cited by 21 publications

(17 citation statements)

References 29 publications

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“…10,11 To identify RCTs published prior to the CLOTHES trial, we searched the Global Resource of Eczema Trials database. 12 At the time of starting the CLOTHES trial, 14 small RCTs assessing the effects of therapeutic clothing had been published: three RCTs investigated silk clothing [DermaSilk TM (AlPreTec Srl, San Donà di Piave, Italy)]; [13][14][15] two investigated silver-coated textiles; 16,17 three investigated cellulose seaweed fibres with silver; [18][19][20] one investigated cellulose; 21 one investigated an anion textile; 22 two investigated types of ethylene vinyl alcohol fibre; 23,24 one investigated borage oil-coated garments; 25 and one investigated cotton and synthetic fibres. 26 Since the start of the trial, an additional study on chitosan-coated textiles has been published.…”

Section: Chapter 1 Introductionmentioning

confidence: 99%

Randomised controlled trial of silk therapeutic garments for the management of atopic eczema in children: the CLOTHES trial

Kim

Bradshaw

Sach

et al. 2017

Health Technol Assess

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Background: Atopic eczema (AE) is a chronic, itchy, inflammatory skin condition that affects the quality of life of children and their families. The role of specialist clothing in the management of AE is poorly understood.Objectives: To assess the effectiveness and cost-effectiveness of silk garments for the management of AE in children with moderate to severe disease.Design: Parallel-group, observer-blind, randomised controlled trial of 6 months’ duration, followed by a 2-month observational period. A nested qualitative study evaluated the beliefs of trial participants, health-care professionals and health-care commissioners about the use of silk garments for AE.Setting: Secondary care and the community in five UK centres.Participants: Children aged 1–15 years with moderate or severe AE.Interventions: Participants were randomised (1 : 1 using online randomisation) to standard care or standard care plus 100% silk garments made from antimicrobially protected knitted sericin-free silk [DermaSilkTM (AlPreTec Srl, San Donà di Piave, Italy) or DreamSkinTM (DreamSkin Health Ltd, Hatfield, UK)]. Three sets of garments were supplied per participant, to be worn for up to 6 months (day and night). At 6 months the standard care group received the garments to use for the remaining 2-month observational period.Main outcome measures: Primary outcome – AE severity using the Eczema Area and Severity Index (EASI) assessed at 2, 4 and 6 months, by nurses blinded to treatment allocation. EASI scores were log-transformed for analysis. Secondary outcomes – patient-reported eczema symptoms (Patient Oriented Eczema Measure); global assessment of severity (Investigator Global Assessment); quality of life of the child (Atopic Dermatitis Quality of Life, Child Health Utility – 9 Dimensions), family (Dermatitis Family Impact Questionnaire) and main carer (EuroQoL-5 Dimensions-3 Levels); use of standard eczema treatments (e.g. emollients, topical corticosteroids); and cost-effectiveness. The acceptability and durability of the clothing, and adherence to wearing the garments, were assessed by parental/carer self-report. Safety outcomes – number of skin infections and hospitalisations for AE.Results: A total of 300 children were randomised (26 November 2013 to 5 May 2015): 42% female, 79% white, mean age 5 years. The primary analysis included 282 out of 300 (94%) children (n = 141 in each group). Garments were worn for at least 50% of the time by 82% of participants. Geometric mean EASI scores at baseline, 2, 4 and 6 months were 8.4, 6.6, 6.0, 5.4 for standard care and 9.2, 6.4, 5.8, 5.4 for silk clothing, respectively. There was no evidence of difference between the groups in EASI score averaged over all follow-up visits adjusted for baseline EASI score, age and centre (ratio of geometric means 0.95, 95% confidence interval 0.85 to 1.07; p = 0.43). This confidence interval is equivalent to a difference of –1.5 to 0.5 in the original EASI scale units. Skin infections occurred in 39 out of 141 (28%) and 36 out of 142 (25%) participants for sta...

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Section: Chapter 1 Introductionmentioning

confidence: 99%

Randomised controlled trial of silk therapeutic garments for the management of atopic eczema in children: the CLOTHES trial

Kim

Bradshaw

Sach

et al. 2017

Health Technol Assess

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“…Researchers have used seaweed’s properties to treat acne, 27 improve skin hydration, 28 and to treat atopic dermatitis. 29-31…”

Section: Resultsmentioning

confidence: 99%

“…Researchers have used seaweed's properties to treat acne, 27 improve skin hydration, 28 and to treat atopic dermatitis. [29][30][31] In a randomised, double-blind controlled trial, a cosmeceutical with zinc and a brown algae extract, Laminaria digitata [Hudson] J. V. Lamouroux (Laminariaceae), was significantly better at reducing acne lesions compared to the vehicle control group. 27 Seaweed extracts have been used to improve skin hydration.…”

Section: Seaweed Macroalgaementioning

confidence: 99%

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Botanicals With Dermatologic Properties Derived From First Nations Healing: Part 2—Plants and Algae

Colantonio

Rivers

2016

J Cutan Med Surg

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“…Searching the Global Resource of Eczema Trials [ 6 ] (last search date: 19 March 2015), 9 small RCTs assessing the effects of therapeutic clothing have been published to date. Two trials investigated silver-coated textiles [ 7 , 8 ]; one investigated cellulose fibres with seaweed enriched with silver ions [ 9 ]; one investigated an anion textile [ 10 ]; two investigated types of ethylene vinyl alcohol fibre [ 11 , 12 ] and three investigated silk clothing (DermaSilk™, Espère Healthcare Ltd, Shefford, UK) [ 13 – 15 ].…”

Section: Introductionmentioning

confidence: 99%

A multi-centre, parallel group superiority trial of silk therapeutic clothing compared to standard care for the management of eczema in children (CLOTHES Trial): study protocol for a randomised controlled trial

Haines

Cowdell

Sach

et al. 2015

Trials

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BackgroundEczema is a chronic, itchy skin condition that can have a large impact on the quality of life of patients and their families. People with eczema are often keen to try out non-pharmacological therapies like silk therapeutic garments that could reduce itching or the damage caused by scratching. However, the effectiveness and cost-effectiveness of these garments in the management of eczema has yet to be proven. The CLOTHES Trial will test the hypothesis that ‘silk therapeutic garments plus standard eczema care’ is superior to ‘standard care alone’ for children with moderate to severe eczema.Methods/DesignParallel group, observer-blind, pragmatic, multi-centre randomised controlled trial of 6 months’ duration.Three hundred children aged 1 to 15 years with moderate to severe eczema will be randomised (1:1) to receive silk therapeutic garments plus standard eczema care, or standard eczema care alone. Primary outcome is eczema severity, as assessed by trained and blinded investigators at 2, 4 and 6 months (using the Eczema Area and Severity Index (EASI)). Secondary outcomes include: patient-reported eczema symptoms (collected weekly for 6 months to capture long-term control); global assessment of severity; quality of life of the child, family and main carer; use of standard eczema treatments (emollients, corticosteroids applied topically, calcineurin inhibitors applied topically and wet wraps); frequency of infections; and cost-effectiveness. The acceptability and durability of the clothing will also be assessed, as will adherence to wearing the garments. A nested qualitative study will assess the views of a subset of children wearing the garments and their parents, and those of healthcare providers and commissioners.Randomisation uses a computer-generated sequence of permuted blocks of randomly varying size, stratified by recruiting hospital and child’s age (< 2 years; 2 to 5 years; > 5 years), and concealed using a secure web-based system. The sequence of treatment allocations will remain concealed until randomisation and data collection are complete.Recruitment is taking place from November 2013 to May 2015, and the trial will be completed in 2016. Full details of results will be published in the National Institute for Health Research Journal series.Trial registrationCurrent Controlled Trials ISRCTN77261365 (registered 11 November 2013).

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A proposal for the use of new silver-seaweed-cotton fibers in the treatment of atopic dermatitis

Cited by 21 publications

References 29 publications

Randomised controlled trial of silk therapeutic garments for the management of atopic eczema in children: the CLOTHES trial

Randomised controlled trial of silk therapeutic garments for the management of atopic eczema in children: the CLOTHES trial

Botanicals With Dermatologic Properties Derived From First Nations Healing: Part 2—Plants and Algae

A multi-centre, parallel group superiority trial of silk therapeutic clothing compared to standard care for the management of eczema in children (CLOTHES Trial): study protocol for a randomised controlled trial

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