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OFFICIAL JOURNAL OF THE SOCIETÀ ITALIANA DI DERMATOLOGIA MEDICA,
CHIRURGICA, ESTETICA E DELLE MALATTIE SESSUALMENTE TRASMESSE (SIDeMaST)
DERMASILK IN LONG-TERM CONTROL
OF INFANTILE A
TOPIC DERMA
TOPIC DERMA
A DOUBLE BLIND RANDOMIZED CONTROLLED TRIAL
C. FONTANINI, I. BER VOLUME 148 - No. 3 - PAGES 293-297 - JUNE 2013
titolo breve: DERMASILK IN LONG-TERM CONTROL OF INFANTILE ATOPIC DERMATITIS primo autore: FONTANINI Rivista: GIORNALE ITALIANO DI DERMATOLOGIA E VENEREOLOGIACod Rivista: G ITAL DERMATOL VENEREOL G ITAL DERMATOL VENEREOL 2013;148:293-7 DermaSilk in long-term control of infantile atopic
dermatitis: a double blind randomized controlled trial
C. FONTANINI 1, I. BERTI 2, L. MONASTA 2, G. LONGO 2 Aim. Atopic dermatitis is a chronic inflammatory disease
University of Trieste, Trieste, Italy characterized by severe itching, skin dryness, blistering and
Institute for Maternal and Child Health remittent-relapse course. The critical feature is a skin bar-
IRCCS "Burlo Garofolo", Trieste, Italy rier dysfunction that leads to epidermal inflammation and to
bacterial superinfection. The aim of our study is to assess the
usefulness of DermaSilk in reducing dermatitis relapses, in
infants affected by atopic dermatitis, previously treated with quality of life for the patients and their families. The
topical corticosteroid and, if needed, with antibiotics.
Methods. This is a double blind randomized study involving determining factor, responsible for the disease, is a
22 infants, aged 4 to 18 months, affected by atopic dermatitis. skin barrier dysfunction (genetically predisposed) 3
Disease severity has been evaluated by the SCORAD Index. which leads to skin inflammation and facilitates bac-
To achieve a complete remission, acute phases were managed terial superinfection, in particular by Staphylococcus
following international guidelines. Subsequently, infants aureus.1
were randomized to either wear a set of DermaSilk body and
Eczema treatment is based on anti-inflammatory tights (group A), or wear clothes in pure cotton (group B) for therapy, in addition to emollients for skin barrier
24 months with the exception of the warmer months (from reconstruction, skin hydration, identification and
mid-May to mid-September).
Results. The use of topical steroid per month was significantly elimination of triggering factors including irritants,
lower in the DermaSilk group compared to the cotton group allergens and infectious agents.4, 5 Fabrics have been
(P=0.006). The subjective evaluation reflecting itching reduc-
included among the physical irritants.5 tion was also statistically significant (P=0.014).
DermaSilk is proposed as a non-irritating tissue Conclusion. This study shows that DermaSilk products can due to its sericin-free composition, with antibacte-
reduce relapses in infants with eczema during the mainte-
rial properties given by an exclusive water resistant nance phase and play a pivotal role in itching control, im-
treatment with AEM 5772/5 (3-trimethylsilypropyl- proving the quality of life of children and their family.
dimethyloctadecyl ammonium chloride), a non-mi- Key words: Eczema - Recurrence - Administration, topical.
grating permanent antimicrobial agent also called AEGIS, that reduces bacteria survival and growth.6 It could be a beneficial device in the treatment of Atopic dermatitis (AD) is a chronic inflamma- atopic dermatitis, through itching reduction and bac- tory disease of the skin characterized by severe terial inhibition.6 itching, dryness, blistering and frequent relapses. It DermaSilk has been demonstrated to be signifi- affects 10% to 20% of children and its prevalence cantly more effective than cotton in the management is increasing.1, 2 AD has a considerable impact on of AD.7, 9-11 Several studies have been conducted to prove its Corresponding author: Dr. I. Berti, MD, Institute for Maternal and efficacy in the acute phase, compared to placebo;6, 7, Child Health, IRCCS "Burlo Garofolo", Via dell'Istria 65/1, 34137 Trie- ste, Italy. E-mail: [email protected] few papers report its efficacy compared to topical Vol. 148 - No. 3 GIORNALE ITALIANO DI DERMATOLOGIA E VENEREOLOGIA DERMASILK IN LONG-TERM CONTROL OF INFANTILE ATOPIC DERMATITIS steroids.8 Only two studies are randomized control- given anti-mite mattresses and pillow covers for the led trials 9, 11 and both aimed to prove DermaSilk ef- beds and pillows of the child and parents.
fectiveness during AD flares.12 Parents were asked to fill daily an open diary re- We strongly believe that eczema relapses need to cording the use of topical corticosteroid, the quantity be treated with steroids and eventually with antimi- and the body area in which the cream was applied.
crobial agents, but we have imagined a possible role All children were treated as needed with mometa- of DermaSilk in reducing relapse recurrence, once sone furoate, a corticosteroid medium power, widely eczema has been controlled with the currently ac- used in the topical treatment of eczema.
cepted therapy. The aim of our study is to evaluate, Every child entering the study was evaluated with in infants affected by AD, the DermaSilk effective- the SCORAD index, which takes into account extent ness measured as topical corticosteroids consume (1 of disease, intensity (edema, erythema, papules, se- tube 30 g) compared to cotton bodies and panties.
cretion, crusts…) and subjective symptoms (itching and sleep loss).13 SCORAD total index ranges from 0 to 103. The severity of atopic dermatitis accord- Materials and methods
ing to the SCORAD is graded as follows: Mild < 25 points, Moderate 25-50 points, and Severe >50 This is a double blind randomized trial involving points.13 The intent of using the SCORAD index was infants younger than 18 months, affected by atopic to divide the children equally by gravity in the two dermatitis, recruited at the dermatologic or allergic groups at the beginning of the study.
clinic of the Institute for Maternal and Child Health Data were analyzed according to the intention to – IRCCS "Burlo Garofolo" – Trieste, Italy, between treat principle.
March 2009 and December 2010. The study was ap- proved by the committee on research ethics at the institution in which the research was conducted and any informed consent from human subjects was ob- tained as required.
Twenty two infants affected by atopic dermatitis, The children were allocated into 2 groups, A (Der- aged 4 to 18 months, were recruited during routine maSilk) and B (cotton), with the intent to minimize visits. Two children were lost at follow up and 20 in- differences related to eczema severity. Neither the fants completed the study. At the end of the study we investigators nor the parents knew whether the child collected all patients' records and we acknowledged was wearing cotton or DermaSilk clothes. We asked that children in group A were wearing DermaSilk the children to wear the clothes provided by AL- cloths while group B wore cotton bodies and panties. PRETEC free of charge, every day for 24 months, All children followed the assigned treatment except except during the summer and very hot days in other one: the parents of a five month old girl assigned to seasons (from mid-May to mid-September). The the DearmaSilk group, after five months of wearing clothes were body long sleeves and panties cover- it, stopped using it because the girl had grown, the ing the trunk, the arms and the legs entirely. Increas- size did not fit anymore, and parents did not ask for ing sizes of DermaSilk or cotton bodies and pan- other clothes as expected by the protocol. For the en- ties were supplied to the children according to child tire period, the girl used five tubes of topical corti- growth. We explained to the parents our interest in costeroid. As for the intention to treat principle, this comparing different kinds of fabrics, but no further girl was kept in the DermaSilk group.
details about the tissues were discussed with them, The data were processed by the Epidemiology and so that they would not be influenced in their judg- Biostatistics Unit of our Institute.
ment. Patients were asked to use only these clothes, Given the small number of data and the difficulty day and night, for the whole duration of the study, in verifying the assumptions of normality and homo- except for the medical controls in our clinic, in order scedasticity, we used exact (Fisher) and non-para- to avoid the identification of the allocation by the metric tests (Mann-Whitney, Kolmogorov Smirnov, Somer's D) for the statistical analysis.
In addition, to minimize differences between chil- All the results are listed in Table I. The study dren due to environmental factors, families were also groups did not differ for age, sex, extension of ec- GIORNALE ITALIANO DI DERMATOLOGIA E VENEREOLOGIA DERMASILK IN LONG-TERM CONTROL OF INFANTILE ATOPIC DERMATITIS Table I.—Description of the sample and differences between children wearing DermaSilk and children wearing cotton bodies and panties. Type of treatment Age in months at enrollment Features of the Atopic Dermatitis at baseline Months of actual use of the jumpsuit Nr. tubes of topical corticosteroid used Nr. tubes/month of topical corticosteroid used M-W P=0.006
Outcome (expressed as itching reduction) Fisher P=0.014
*In the Cotton and Silk columns, data are expressed as frequencies and percentages, or medians and interquartile ranges.
**Fisher: two-tailed Fisher exact test; M-W: non-parametric Mann-Whitney test for equality of populations for continuous data; K-S: non-parametric Kolmogorov-Smirnov test for the equality of continuous, one-dimensional probability distributions; D: non-parametric Somer's D coefficient measures the strength of association between two ordered scale variables; χ2: Chi-square test.
zema, and SCORAD index at baseline. There was a industrialized countries during the past three dec- male prevalence in both groups (73% group A and ades, with 15% to 30% of children affected.15 Man- 67% group B).
agement of AD, when the skin does not present acute The number of steroid tubes used per month dur- flare, is based on hydrating topical treatment and ing the study period was significantly lower in group avoidance of specific and unspecific provocation fac- A (DermaSilk) if compared to group B (cotton) tors.16 Anti-inflammatory treatment is used for ex- (P=0.006). Moreover the patient/parents satisfaction acerbation and among them topical corticosteroids was higher in the DermaSilk group (P=0.014), espe- remain the first choice.17-19 Systemic anti-inflam- cially in regard to itching decrease, main symptom matory treatment should be kept to a minimum, but responsible for child discomfort.
may be necessary in rare refractory cases and might be needed when eczema is very severe and skin in- volvement very extensive.20 Microbial colonization and superinfection (e.g. with Staphylococcus aureus, Malassezia furfur) can have a role in disease exac- Atopic dermatitis is a very common chronic in- erbation and can justify the use of antimicrobials in flammatory disease starting in early age for the ma- addition to the anti-inflammatory treatment.21 jority of children.1, 14 Its prevalence has doubled in We have tested the effectiveness of DermaSilk Vol. 148 - No. 3 GIORNALE ITALIANO DI DERMATOLOGIA E VENEREOLOGIA DERMASILK IN LONG-TERM CONTROL OF INFANTILE ATOPIC DERMATITIS in reducing eczema flares among children younger guida internazionali. Successivamente i bambini sono stati randomizzati in due gruppi ed hanno indossato un body e than 18 months with eczema, treated following rec- una calzamaglia di DermaSilk (gruppo A), o abiti equiva- ommendations of international guidelines.16, 20, 21 lenti in puro cotone (gruppo B) per 24 mesi, con l'eccezio- Other studies have already proved DermaSilk utility ne dei mesi estivi (da metà maggio a metà settembre).
in eczema management 6-11 either compared to pla- Risultati. L'utilizzo mensile di steroidi topici è risultata cebo or to topical steroid. We believe that dermatitis significativamente più bassa nel gruppo DermaSilk rispetto needs to be treated with steroids locally when active al gruppo cotone (P=0,006), così come la valutazione sog- and no other device can substitute this approach with gettiva di efficacia, che rifletteva prevalentemente la ridu- the same results. Our intent, however, was to assess zione prurito (P=0,014).
Conclusioni. Questo studio dimostra che gli abiti Der- if DermaSilk could be of any help in prevention of maSilk possono ridurre le recidive in bambini con eczema eczema recurrence and our results support this hy- durante la fase di mantenimento e svolgere un ruolo cen- trale nel controllo del prurito, migliorando la qualità della We observed a consistently lower use of topical vita dei bambini e dei loro familiari.
corticosteroid among children in group A (Der- Parole chiave: Eczema - Ricorrenza - Somministrazione maSilk) compared to group B (cotton) (P=0.006). topica.
The subjective evaluation expressed by families (100% DermaSilk group A, group B 45% cotton; P=0.014) was also statistically significant.
1. Bieber T. Atopic Dermatitis. N Engl J Med 2008;358:1483-94.
2. Brown S, Reynolds NJ. Atopic and non-atopic eczema. BMJ 2006;332: 584-8.
3. Irvine AD, McLean WH, Leung DY. Filaggrin mutations associated In conclusion, this study found a possible role of with skin and allergic diseases. N Engl J Med 2011;365:1315-27.
4. Tan BB, Weald D, Strickland I, Friedmann PS. Double-blind con- DermaSilk in reducing relapses of AD. In particular, trolled trial of effect of housedust-mite allergens avoidance on at- the use of DermaSilk leaded to a reduction of subjec- opic dermatitis. Lancet 1996;347:15-8.
tive symptoms such as itching, the most important 5. Hanifin JM, Cooper KD, Ho VC, Kang S, Krafchik BR, Margolis DJ et al. Guidelines of care for atopic dermatitis. J Am Acad Der- factor responsible for the deterioration of the qual- ity of life of both patients and their families, giving 6. Stinco G, Piccirillo F, Valent F. A randomized double-blind study to greater benefits than cotton, and without any side ef- investigate the clinical efficacy of adding a non-migrating antimi- crobial to a special silk fabric in the treatment of atopic dermatitis. 7. Patrizi A, Giacomini F, Gurioli C, Neri I. Clinical effectiveness of a special silk textile in the treatment of recurrent pediatric inflam- matory vulvitis: an open label pilot study. G Ital Dermatol Venereol 8. Senti G, Steinmann LS, Fischer B, Kurmann R, Storni T, Johan- DermaSilk nel controllo a lungo termine della dermatite sen P et al. Antimicrobial Silk Clothing in the Treatment of Atopic atopica infantile: uno studio randomizzato controllato in Dermatitis Proves Comparable to Topical Corticosteroid Treatment. doppio cieco 9. Koller DY, Halmerbauer G, Böck A, Engstler G. Action of a Silk Obiettivi. La dermatite atopica è una malattia infiam- fabric treated with AEGIS in children with Atopic Dermatitis: a matoria cronica della cute ad andamento intermittente, ca- 3-month trial. Ped Allergy Immunol 2007;18:335-8.
ratterizzata da prurito, secchezza cutanea, vescicolazione. 10. Ricci G, Patrizi A, Bendandi B, Menna G, Varotti E, Masi M. Clini- L'elemento patogenetico fondamentale è una disfunzione cal effectiveness of a silk fabric in the treatment of atopic dermatitis. Br J Dermatol 2004;150:127-31.
della barriera cutanea che porta a infiammazione epidermi- 11. Ricci G, Patrizi A, Mandrioli P, Specchia F, Medri M, Menna G et ca e sovrainfezione batterica. Lo scopo del nostro studio è al. Evaluation of the antibacterial activity of a special silk textile in stato quello di valutare l'utilità del tessuto DermaSilk nel the treatment of atopic dermatitis. Dermatology 2006;213:224-7.
ridurre le recidive in bambini con dermatite in remissione, 12. Vlachou C, Thomas KS, Williams HC. A case report and critical precedentemente trattati con corticosteroidi topici e, se ne- appraisal of the literature on the use of DermaSilk in children with cessario, con antibiotici.
atopic dermatitis. Clin Exp Dermatol 2009;34:e901-3.
13. Kunz B, Oranje AP, Labrèze L, Stalder JF, Ring J, Taïeb A. Clinical Metodi. Questo è un studio in doppio cieco randomiz- validation and guidelines for the SCORAD index: consensus report zato condotto su 22 bambini, dai 4 ai 18 mesi, affetti da of the European Task Force on Atopic Dermatitis. Dermatology dermatite atopica. La gravità della malattia è stata valutata mediante l'indice SCORAD. Per ottenere una remissione 14. Leung DY, Bieber T. Atopic dermatitis. Lancet 2003;361:151-60.
completa, le fasi acute sono state gestite seguendo le linee 15. Williams H, Flohr C. How epidemiology has challenged 3 pre- GIORNALE ITALIANO DI DERMATOLOGIA E VENEREOLOGIA DERMASILK IN LONG-TERM CONTROL OF INFANTILE ATOPIC DERMATITIS vailing concepts about atopic dermatitis. J Allergy Clin Immunol M, Eigenmann P et al. Diagnosis and treatment of atopic derma- titis in children and adults: European Academy of Allergology and 16. National Institute for Health and Clinical Excellence. Atopic ec- Clinical Immunology/American Academy of Allergy, Asthma and zema in children: management of atopic eczema in children from Immunology/PRACTALL Consensus Report. Allergy 2006;61:969- birth up to the age of 12 years. London: NICE, 2007.
17. Flohr C, Williams HC. Evidence based management of atopic ec- 21. Darsow U, Lübbe J, Taïeb A, Seidenari S, Wollenberg A, Calza AM zema. Arch Dis Child Educ Pract Ed 2004;84:35-9.
et al. Position paper on diagnosis and treatment of atopic dermatitis 18. Hanifin J, Gupta AK, Rajagopalan R. Intermittent dosing of fluti- for the European Task Force on Atopic Dermatitis. J Eur Acad Der- casone proprionate cream for reducing the risk of relapse in atopic matol Venereol 2005;19:286-95.
dermatitis patients, Br J Dermatol 2002;147: 528-37.
19. Berth-Jones J, Damstra RJ, Golsch S, Livden JK, Van Hooteghem Conflicts of interest.—The authors certify that there is no conflict of O, Allegra F et al. Twice weekly fluticasone propionate added to interest with any financial organization regarding the material discussed emollient maintenance treatment to reduce risk of relapse in atopic in the manuscript.
dermatitis: randomized, double blind, parallel group study. BMJ Received on March 6, 2013.
20. Akdis CA, Akdis M, Bieber T, Bindslev-Jensen C, Boguniewicz Accepted for publication on April 5, 2013.
Vol. 148 - No. 3 GIORNALE ITALIANO DI DERMATOLOGIA E VENEREOLOGIA

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