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Management of atopic eczema inprimary care

A national clinical guideline

March 2011

125

Scottish Intercollegiate Guidelines Network

Part of NHS Quality Improvement Scotland

SIGN

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KEY TO EVIDENCE STATEMENTS AND GRADES OF RECOMMENDATIONS

LEVELS OF EVIDENCE

1++ High quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias

1+ Well conducted meta-analyses, systematic reviews, or RCTs with a low risk of bias

1 - Meta-analyses, systematic reviews, or RCTs with a high risk of bias

2++High quality systematic reviews of case control or cohort studies

High quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the

relationship is causal

2+Well conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that therelationship is causal

2 - Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal

3 Non-analytic studies, eg case reports, case series

4 Expert opinion

GRADES OF RECOMMENDATION

Note: The grade of recommendation relates to the strength of the evidence on which the recommendation is based. It does not

reect the clinical importance of the recommendation.

A

At least one meta-analysis, systematic review, or RCT rated as 1++,and directly applicable to the target population; or

A body of evidence consisting principally of studies rated as 1+,directly applicable to the target population, and demonstrating overall consistency of results

B

A body of evidence including studies rated as 2++,directly applicable to the target population, and demonstrating overall consistency of results; or

Extrapolated evidence from studies rated as 1++ or 1+

C

A body of evidence including studies rated as 2+,directly applicable to the target population and demonstrating overall consistency of results; or

Extrapolated evidence from studies rated as 2++

DEvidence level 3 or 4; or

Extrapolated evidence from studies rated as 2+

GOOD PRACTICE POINTS

Recommended best practice based on the clinical experience of the guideline development group

NHS Evidence has accredited the process used by Scottish Intercollegiate GuidelinesNetwork to produce guidelines. Accreditation is valid for three years from 2009and is applicable to guidance produced using the processes described in SIGN50: a guideline developers handbook, 2008 edition (www.sign.ac.uk/guidelines/

fulltext/50/index.html). More information on accreditation can be viewed atwww.evidence.nhs.uk

NHS Quality Improvement Scotland (NHS QIS) is committed to equality and diversity and assesses all its publications for likelyimpact on the six equality groups defined by age, disability, gender, race, religion/belief and sexual orientation.

SIGN guidelines are produced using a standard methodology that has been equality impact assessed to ensure that these equalityaims are addressed in every guideline. This methodology is set out in the current version of SIGN 50, our guideline manual, whichcan be found at www.sign.ac.uk/guidelines/fulltext/50/index.html. The EQIA assessment of the manual can be seen at www.sign.ac.uk/pdf/sign50eqia.pdf. The full report in paper form and/or alternative format is available on request from the NHS QIS Equalityand Diversity Officer.

Every care is taken to ensure that this publication is correct in every detail at the time of publication. However, in the event oferrors or omissions corrections will be published in the web version of this document, which is the definitive version at all times.This version can be found on our web site www.sign.ac.uk.

This document is produced from elemental chlorine-free material and is sourced from sustainable forests.

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Scottish Intercollegiate Guidelines Network

Mm m m A national clinical guideline

March 2011

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ManageMent of atopic eczeMa in priMary care

ISBN 978 1 905813 72 8

Published March 2011

c xScottish Intercollegiate Guidelines Network (SIGN). Management of atopic eczema in primar care.

Edinburgh: SIGN; 2011. (SIGN publication no. 125). [March 2011]. Aailable from URL: http://www.sign.ac.uk

SIGN consents to the photocoping of this guideline for thepurpose of implementation in NHSScotland

Ssh i gds nke Hs, 8 -10 Hsd cs

edbh eH7 5ea.s..k

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contentS

cs

1 id ................................................................................................................ 1

1.1 The need for a guideline .............................................................................................. 1

1.2 Remit of the guideline .................................................................................................. 1

1.3 Definitions ................................................................................................................... 2

1.4 Statement of intent ....................................................................................................... 2

2 K mmds ................................................................................................. 4

2.1 Referral ........................................................................................................................ 4

2.2 Emollient therap ......................................................................................................... 4

2.3 Topical corticosteroid therap ...................................................................................... 4

2.4 Topical calcineurin inhibitors ....................................................................................... 4

2.5 Oral antibiotics ............................................................................................................ 4

3 Dss, d d .................................................................... 5

3.1 Diagnosis ..................................................................................................................... 5

3.2 Seerit assessment and ualit of life .......................................................................... 5

3.3 Dermatological comorbidities and associated disorders ................................................ 6

3.4 Referral ........................................................................................................................ 6

3.5 Educational interentions ............................................................................................. 6

4 em h ........................................................................................................ 74.1 Effectieness ................................................................................................................. 7

4.2 Application techniue .................................................................................................. 8

5 t sd h..................................................................................... 9

5.1 Potenc ........................................................................................................................ 9

5.2 Effectieness ................................................................................................................. 9

5.3 Aderse effects ............................................................................................................. 10

5.4 Application techniue .................................................................................................. 11

6 t hbs ...................................................................................... 12

6.1 Status and indications for use ....................................................................................... 12

6.2 Comparatie effectieness with topical corticosteroids ................................................ 12

6.3 Reduction in use of topical corticosteroids ................................................................... 12

6.4 Aderse effects ............................................................................................................. 13

6.5 Maintenance therap .................................................................................................... 13

6.6 Recommendations ....................................................................................................... 13

7 Dsss d m .............................................................................. 14

7.1 Dressings ..................................................................................................................... 14

7.2 Wet wrap treatment ..................................................................................................... 14

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8 amb mss ............................................................................................... 15

8.1 Introduction ................................................................................................................. 15

8.2 Effectieness of antimicrobial measures ........................................................................ 15

9 ahsms ............................................................................................................. 1610 em s.................................................................................................. 17

10.1 House dust mite ........................................................................................................... 17

10.2 Exposure to pets ........................................................................................................... 17

10.3 Clothing ....................................................................................................................... 17

10.4 Temperature and humidit ........................................................................................... 17

10.5 Irritants ......................................................................................................................... 17

11 D s ................................................................................................... 18

11.1 Food allerg and dietar exclusion ............................................................................... 18

11.2 Infant feeding ............................................................................................................... 18

11.3 Food supplements ........................................................................................................ 19

12 cmm d hs ................................................................... 20

12.1 Pschological and relaxation therapies ......................................................................... 20

12.2 Herbal remedies ........................................................................................................... 20

12.3 Dead Sea treatment ...................................................................................................... 20

12.4 Other therapies ............................................................................................................ 20

13 ps m .............................................................................................. 21

13.1 Checklist for proision of information .......................................................................... 21

13.2 Sources of further information ...................................................................................... 22

14 imm h d ......................................................................................... 23

14.1 Recommendations with potential resource implications ............................................... 23

14.2 Auditing current practice ............................................................................................. 23

14.3 Additional adice to NHSScotland from the Scottish Medicines Consortium ................ 24

15 th d bs ....................................................................................................... 25

15.1 Sstematic literature reiew .......................................................................................... 25

15.2 Recommendations for research .................................................................................... 25

15.3 Reiew and updating ................................................................................................... 25

16 Dm h d ..................................................................................... 26

16.1 Introduction ................................................................................................................. 26

16.2 The guideline deelopment group ................................................................................ 26

16.3 Acknowledgements ...................................................................................................... 27

16.4 Consultation and peer reiew ....................................................................................... 27

abbs .............................................................................................................................. 29

axs .................................................................................................................................... 30

rs .................................................................................................................................. 33


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1 id

1.1 tHe neeD for a guiDeline

Atopic eczema (AE) is a common chronic inflammator skin disorder. The cause of atopiceczema is complex and not full understood. Both genetic and enironmental factors are likelto contribute, with defects in epithelial barrier function arising from abnormalities in structuralproteins such as filaggrin making the skin both excessiel permeable and more prone to damagefrom enironmental irritants and allergens.1

The disorder affects both sexes euall and usuall starts in the first months of life. In the UK,15-20% of school-aged children and 2-10% of adults will be affected b the condition at somestage.2 A stud of atopic eczema in the Scottish population found an oerall one-ear periodprealence of 2.3%.3 Prealence was highest in children less than two ears of age (9.8%), anddiminished with increasing age. Thirt eight per cent of all patients with atopic eczema wereadults. The most common progression of atopic eczema is for it to resole during childhood,but it ma persist into adult life or recur in the teenage or earl adult ears. Occasionall, it

ma deelop for the first time in mature adulthood.

Depending on disease seerit, atopic eczema ma hae a considerable aderse effect on theualit of life of affected indiiduals (eg through sleep disturbance) and their families. Atopiceczema ma adersel influence a childs emotional and social deelopment and ma predisposeto pschological difficulties.4,5

The annual cost to the NHS of treating atopic eczema in the mid-nineties was 125 million,and the annual personal cost to the UK population 297 million.6 The annual societal cost oflost working das was estimated at 43 million, making the total annual UK expenditure onatopic eczema in the mid-nineties 465 million. In 2002 the cost of communit dispensedprescriptions for topical corticosteroids for atopic eczema was estimated as 11.6 million. 2

The maorit of the treatment for atopic eczema is deliered b the primar healthcare team,

with onl a minorit of patients referred to secondar care.7 Atopic eczema is a multifacetedcondition that can be a therapeutic challenge, especiall in primar care. There appears to bereal potential for improing the outcome of its treatment in the communit8 and perhaps thecost effectieness of treatment.

1.2 reMit of tHe guiDeline

1.2.1 OvERALL OBjECTIvES

This guideline focuses on proiding recommendations for the management of atopic eczemain children and adults in primar care, based on current eidence for best practice. It includesadice on the arious topical treatments for atopic eczema (including emollients (moisturisers),

topical corticosteroids, topical calcineurin inhibitors and dressings), anti-infectie treatments(such as antibiotics and antiseptics), antihistamines, complementar therapies and the roles ofdiet and enironmental factors. It excludes treatments that are usuall carried out in secondarcare, such as phototherap and sstemic immunosuppressant drugs. The ke uestions onwhich the guideline is based are outlined in Annex 1.

1.2.2 TARGET USERS OF THE GUIDELINE

This guideline will be of interest to all communit based healthcare professionals who managepatients with atopic eczema particularl general practitioners, health isitors, practice andcommunit based nurses, dietitians and pharmacists, as well as patients with atopic eczemaand their carers.

1 introDuction

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1.3 DefinitionS

The words eczema and dermatitis are interchangeable: atopic eczema is the same as atopicdermatitis. The studies cited use both terms, but for consistenc, the condition is referred toas atopic eczema throughout the guideline. The term eczema describes a skin disorder that is

usuall itch and which is characterised b obserable changes that include redness, blistering,oozing, crusting, scaling, thickening and sometimes colour change although not all of thesechanges will necessaril occur together.

The term atopic is used to describe conditions such as eczema, asthma, seasonal rhinitis andha feer, which often hae a genetic basis and ma be associated with sensitisation to commonenironmental allergens.

1.4 StateMent of intent

This guideline is not intended to be construed or to sere as a standard of care. Standardsof care are determined on the basis of all clinical data aailable for an indiidual case andare subect to change as scientific knowledge and technolog adance and patterns of care

eole. Adherence to guideline recommendations will not ensure a successful outcome ineer case, nor should the be construed as including all proper methods of care or excludingother acceptable methods of care aimed at the same results. The ultimate udgement must bemade b the appropriate healthcare professional(s) responsible for clinical decisions regardinga particular clinical procedure or treatment plan. This udgement should onl be arried atfollowing discussion of the options with the patient, coering the diagnostic and treatmentchoices aailable. It is adised, howeer, that significant departures from the national guidelineor an local guidelines deried from it should be full documented in the patients case notesat the time the releant decision is taken.

1.4.1 PRESCRIBING OF MEDICINES OUTWITH THEIR MARKETING AUTHORISATION

Recommendations within this guideline are based on the best clinical eidence. Some

recommendations ma be for medicines prescribed outwith the marketing authorisation (productlicence). This is known as off label use. It is not unusual for medicines to be prescribed outwiththeir product licence and this can be necessar for a ariet of reasons.

Generall the unlicensed use of medicines becomes necessar if the clinical need cannot be metb licensed medicines; such use should be supported b appropriate eidence and experience.9

Medicines ma be prescribed outwith their product licence in the following circumstances:

for an indication not specified within the marketing authorisation

for administration ia a different route

for administration of a different dose.

Prescribing medicines outside the recommendations of their marketing authorisation alters

(and probabl increases) the prescribers professional responsibilit and potential liabilit. Theprescriber should be able to ustif and feel competent in using such medicines.

An practitioner following a SIGN recommendation and prescribing a licensed medicineoutwith the product licence needs to be aware that the are responsible for this decision, andin the eent of aderse outcomes, ma be reuired to ustif the actions that the hae taken.

Prior to prescribing, the licensing status of a medication should be checked in the currentersion of the British National Formular (BNF).9


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1.4.2 ADDITIONAL ADvICE TO NHSSCOTLAND FROM NHS qUALITy IMPROvEMENTSCOTLAND AND THE SCOTTISH MEDICINES CONSORTIUM

NHS qIS processes multiple technolog appraisals (MTAs) for NHSScotland that hae beenproduced b the National Institute for Health and Clinical Excellence (NICE) in England andWales.

The Scottish Medicines Consortium (SMC) proides adice to NHS Boards and their Area Drugand Therapeutics Committees about the status of all newl licensed medicines and an maornew indications for established products.

SMC adice and NHS qIS alidated NICE MTAs releant to this guideline are summarised insection 14.3.

1 introDuction

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2 K mmds

The following recommendations were highlighted b the guideline deelopment group asthe ke clinical recommendations that should be prioritised for implementation. The grade ofrecommendation relates to the strength of the supporting eidence on which the eidence isbased. It does not reflect the clinical importance of the recommendation.

2.1 referral

D a m dms d shd b d bh h h s ss m hm (widespread herpessimplex).

D ps shd b d dms h h s:

h dss

h d sd ms

sh s s bms

sd .

2.2 eMollient tHerapy

c ps h m shd h m h ms.

2.3 topical corticoSteroiD tHerapy

a ps shd b dsd h m h d m h sds.

B ps h m shd b dsd sds d.

a t k m h h sd shd b sdd s h md s m x ss.

2.4 topical calcineurin inHiBitorS

c t ms shd b sdd, s d s d d, sh m, m m md s m h hs b d b sds h h s ss sk m

ds s m h sd s, sk h.

2.5 oral antiBioticS

B o bs mmdd h m -d m.


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2++

2+

4

2+

3

5

3 Dss, d d

3.1 DiagnoSiS

There are no laborator or diagnostic tests for atopic eczema. The diagnosis of atopic eczemais based on isual assessment and patient histor.

Diagnostic criteria hae been deeloped but are mainl used in research settings. In a sstematicreiew of cross-sectional and case control studies, the UK diagnostic criteria were the mostextensiel alidated for atopic eczema in comparison to the Hanifin and Raka diagnosticcriteria, Schulz-Larsen criteria, Diepgen criteria, and Kang and Tian diagnostic criteria. Thesensitiit and specificit for the UK diagnostic criteria ranged from 10-95% and 90.4-98.3%respectiel. The authors recommended the use of criteria in interentional studies as opposedto dail clinical management.10 The UK diagnostic criteriaare described in Table 1.11

Table 1: UK Working Party Diagnostic Criteria11

The patient must report an itch skin condition (or parental report of scratching or rubbingin a child) in the last 12 months, plus three or more of the following:

histor of inolement of the skin creases (front of elbows, behind knees, fronts of ankles,around neck or around ees)

personal histor of asthma or hafeer (or histor of atopic disease in first degree relatieif child aged under four ears)

a histor of generall dr skin in the last ear

onset under the age of two ears (not used if child aged under four ears)

isible flexural dermatitis (including dermatitis affecting cheeks or forehead and outeraspects of limbs in children under four ears).

A sstematic reiew suggests that there is no eidence that atopic testing such as skin pricktesting or measurement of specific immunoglobulin E (IgE) leels enhances the initial diagnosisof atopic eczema.12

3.2 Severity aSSeSSMent anD quality of life

A guide to isual assessment of eczema seerit, as proposed b NICE, is described in Table 2.

Table 2: A guide to severity of eczema1

Sk/hs s

Clear Normal skin, no eidence of actie atopic eczema

Mild Areas of dr skin, infreuent itching (with or without small areas of redness)

Moderate Areas of dr skin, freuent itching, redness (with or without excoriation andlocalised skin thickening)

Seere Widespread areas of dr skin, incessant itching, redness (with or withoutexcoriation, extensie skin thickening, bleeding, oozing, cracking and alterationof skin pigmentation)

There are numerous scoring sstems for assessing the seerit of atopic eczema. In a sstematicreiew, onl three were considered sufficientl tested and alidated; SCORing Atopic Dermatitis(SCORAD), Eczema Area and Seerit Index (EASI) and Patient Orientated Eczema Measure(POEM).13

There is a correlation between seerit of eczema smptoms and some aspects of ualit oflife (qoL) for patients and their families, with factors such as itching and lack of sleep haing

a high impact.14,15

; ;When assessing the seerit of atopic eczema, healthcare professionals should take intoconsideration the aderse effects on ualit of life of patients and their families.

3 DiagnoSiS, referral anD patient eDucation

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4

1++

6

3.3 DerMatological coMorBiDitieS anD aSSociateD DiSorDerS

Atopic eczema ma predispose to and coexist with other dermatological disorders thatma complicate diagnosis, such as hper-IgE sndrome, scabies, herpes simplex infection,staphlococcal and streptococcal infection, superficial fungal infection and contact dermatitis

(irritant and allergic).Widespread herpes simplex (eczema herpeticum) should be considered in an patient withrapidl deteriorating atopic eczema.

Some rare genetic disorders are associated with a pattern of cutaneous inflammation that resemblesatopic eczema. These include Wiskott-Aldrich sndrome, anhidrotic ectodermal dsplasia,phenlketonuria, Nethertons sndrome, ataxia-telangiectasia and agammaglobulinaemia.

3.4 referral

The Centre for Change and Innoation for NHSScotland formed criteria for referral to adermatolog consultant and criteria for emergenc referral.16 The recommendations below areadapted from these criteria. Referral for consideration of food allerg inestigation is discussed

in section 11.1.

D a m dms d shd b d bh h h s ss m hm (widespread herpessimplex).

D ps shd b d dms h h s:

h dss

h d sd ms

sh s s bms

sd .

3.5 eDucational interventionS

A Cochrane reiew identified four studies on the effect of parent education interentions oneczema seerit in children. In two of the studies the interentions were effectie in termsof reduced clinical seerit scores. There was heterogeneit in the format (group and one toone), content and setting (nurse-led, multidisciplinar) of the interentions meaning that resultscould not be combined. The reiew also described the findings of studies examining ariousgroup and indiidual educational interentions for adult patients and how these ma improeknowledge and understanding of treatments.17

The lack of consistenc in the trials means that no eidence based recommendation can be made.


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1-

1+

1++

4

4

7

4 em h

4.1 effectiveneSS

Emollients (moisturisers) soften the skin, aid in restoring the impaired barrier function of theepidermis, reduce the itch of dr skin,18 increase the efficac of topical corticosteroids19,20and hae a steroid sparing action.21 Emollients replace the natural surface oils which tend tobe deficient in AE and which are essential both in preenting irritant materials, infection andallerg-inducing substances from entering the skin and water from leaing the skin.

Although long term emollient therap is considered the mainsta of treating atopic eczema,a sstematic reiew conducted in 2000 did not identif an high ualit clinicall releanteidence in support of emollient monotherap.22

Expert opinion (from a clinical guideline for children but applicable to adults) supports theuse of emollients in the treatment of atopic eczema to restore the defectie skin barrier. Itrecommends that healthcare professionals offer a range of emollients allowing selection of themost appropriate to the patient, and that prescriptions should be reiewed freuentl. 1

c ps h m shd h m h ms.

To optimise adherence to emollient therap, creams, lotions, ointments, or a combinationcan be used, depending on patient choice. Prescriptions should be reiewed regularl.

Patients and parents/carers of children should be educated about regularl applingemollients onto dr skin and eczematous areas een when eczema is under control.

Table 3 describes the tpes of emollient products aailable.1 Seeral of the products are designedto substitute for conentional bath and shower products, which ma act as dring agents ordeposit irritant residues onto the skin and should be aoided b people with AE.

Table 3: Types of emollient products1

t Ds

Emollient creams and ointments These products are designed to be left on the skin.Creams soak into the skin faster than ointments.

Emollient soap substitutes These products contain emollient ingredients wither mild emulsifiers. The are used instead of soapand other detergents.

Emollient semidispersing bath oils These contain oils and emulsifiers that disperse the oilin the water. This combination has a cleansing effect ifgentl rubbed oer the skin.

Non-dispersing emollient bath oils These products contain oils with no emulsifingagent. The oil forms a laer on the surface of thewater which is deposited on the skin on getting out ofthe bath.

Aduant emollient products Some emollient products contain additionalingredients such as antipruritics and antiseptics.

4 eMollient tHerapy

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8

4.2 application tecHnique

No eidence was identified on the freuenc with which to appl emollients or the mostappropriate application techniues. When an eczema treatment regimen inoles both anemollient and topical corticosteroid (TCS), there is no eidence on which to base their order

of application. Suggested prescribing uantities for a week of emollient therap are shown inAnnex 2.

The following good practice points are based on the clinical experience of the guidelinedeelopment group.

Patients should be adised to appl emollients liberall and freuentl (at least 2-4times a da). It is particularl important to use emollients during or after bathing.

Sufficient uantit of emollient should be prescribed.

The emollient should be applied smoothl in the general direction of growth ofbod hair in order to preent accumulation at hair bases which might predispose tofolliculitis.

Emollients can become contaminated with bacteria. The use of pump dispensersminimises the risk of microbial contamination. If the emollient is in a pot the reuiredamount should be remoed with a clean spoon or spatula. Fingers should not beinserted into pots. Emollients should not be shared with others.


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4

1++

1+

1++

9

5 t sd h

5.1 potency

Topical corticosteroids (TCS) are categorised into four groups according to potenc (ie theeffectieness in reducing inflammation): mild, moderatel potent, potent and er potent.9 TCSpotenc is dependent on a number of factors including the uniue properties of corticosteroidmoiet, formulation and penetration into the skin. Potenc of a TCS is not simpl a function ofconcentration. The British National Formular outlines the range of compounds and formulationsaailable.9

No good ualit eidence was identified to assist in the choice of TCS potenc in the treatmentof atopic eczema.

The NICE guideline on management of atopic eczema in children suggested a stepped/matchedapproach, matching potenc of TCS with seerit of the eczema: mild potenc TCS for milddisease, moderate potenc for moderate disease and potent TCS resered for short term usein seere eczema.1

The choice of TCS potenc should be tailored to the age of the patient, the bod regionbeing treated, and the degree to which the skin is inflamed. For delicate areas of skin,such as the face and flexures, onl mild or moderatel potent preparations should beused. On the face, especiall in children, it is reasonable to start with a mildl potent TCS.

5.2 effectiveneSS

A sstematic reiew of randomised controlled trials (RCT) identified 83 on the use of TCS in AE.Studies were generall of less than one month duration and of poor methodological ualit. Awide range of treatment outcome measures were used. Although results of studies could notbe combined, where outcomes were reported there were large positie treatment effects when

compared to placebo.22

No comprehensie eidence was identified comparing TCS with each other in terms ofeffectieness.

Continuation with emollient therap during treatment with TCS has been shown to improetreatment outcomes (see section 4.1).19,20

a ps shd b dsd h m h d m h sds.

5.2.1 ONCE vERSUS TWICE DAILy APPLICATION

A sstematic reiew of 10 RCTs reiewed moderate to potent TCS in patients with moderate

to seere eczema to assess the optimum freuenc of application. Both once dail and twicedail application of TCS was effectie, without clear eidence that the twice dail applicationconfers an significant clinical adantage oer once dail. The methodological ualit for themaorit of studies was deemed to be poor (poor concealment, inadeuate randomisation) andparticipant numbers were small.2

B ps h m shd b dsd sds d.

If there is an inadeuate response to once dail application, the freuenc should beincreased to twice dail.

5 topical corticoSteroiD tHerapy

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1+

1+

1++

1++

1+

1+

1+

10

5.2.2 MAINTENANCE THERAPy

Although constant use of TCS is undesirable due to risk of local and sstemic aderse effects, noeidence was identified to support an particular TCS treatment strateg in terms of maximumduration of continuous use or the freuenc with which this can be repeated.

Three RCTs suggest that adding twice weekl TCS application to emollient based maintenancetherap following stabilisation of eczema reduces relapse rate.

Adults and children with AE receiing long term (up to 48 weeks) fluticasone propionate cream(0.05%) twice weekl in addition to regular dail emollients were 7.7 times less likel (95%CI (confidence interal) 4.6 to 12.8, p

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1-

2+

11

Three small short term studies conducted since the sstematic reiew were identified.

A randomised stud of the effect of a two week course of a potent TCS (mometasone furoate)on bone growth in children with mild to moderate atopic eczema showed no statisticallsignificant effect.28

In an open label stud, the dail application of a er potent TCS (fluocinonide cream, 0.1%)to at least 20% of the bod surface area of children as oung as three months for two weeksdid not suppress the HPA axis in an child. The twice dail application of fluocinonide cream(0.1%) did cause HPA axis suppression in 10% of patients, although the risk was no greater forinfants and oung children than for adolescents.29

A potent TCS (hdrocortisone butrate, 0.1%) applied three times dail to at least 25% of thebod surface of children with atopic eczema aged 5-12 ears, for up to four weeks, was notassociated with adrenal suppression in an of the 20 children in the stud. 30

There is insufficient consistent eidence on which to base a recommendation for growthmonitoring.

5.4 application tecHnique

The fingertip unit (FTU) has been used as a method of determining the amount of TCS to appl(see Annex 3). The FTU is defined as the olume of a ribbon of cream or ointment the length ofthe distal phalanx of an adults index finger expressed from a tube with a 5 mm diameter nozzle.31

The fingertip unit should be used to guide patients on topical corticosteroid uantitiesreuired.

Patients should be adised to appl topical corticosteroids in an amount sufficient toadeuatel coer the areas of inflamed skin een if the skin is excoriated.

5 topical corticoSteroiD tHerapy

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1++

1++

1+

1+

1++

1+

12

6 t hbs

6.1 StatuS anD inDicationS for uSe

Topical calcineurin inhibitors (TCIs) are non-steroidal immunomodulating agents licensed for thetreatment of atopic eczema. Two TCIs are aailable: tacrolimus as 0.03% and 0.1% ointments(both licensed for moderate to seere eczema, the 0.03% ointment licensed for use in childrenaged two ears and oer), and 1% pimecrolimus cream (licensed for mild to moderate eczemain patients aged two ears and oer).

In 2010 the Scottish Medicines Consortium issued adice restricting the use of tacrolimus0.03% and 0.1% ointments for treatment and maintenance therap to initiation b doctorswith a specialist interest and experience in treating atopic dermatitis using immunomodulatortherap. This can include general practitioners (see section 14.3).

In 2004 the Scottish Medicines Consortium reected pimecrolimus for use within NHSScotland.

Since the long term safet of both TCIs is still being ealuated it is currentl recommended

that TCIs should not be used as first line treatment unless there is a specific reason to aoid orreduce the use of topical corticosteroids.1,9

6.2 coMparative effectiveneSS witH topical corticoSteroiDS

6.2.1 ADULTS

A sstematic reiew identified two comparisons of tacrolimus ointment with potent TCS in adultswith moderate to seere AE. Tacrolimus (0.1%) was as effectie as potent TCS in achieingmarked improement in the condition at three weeks. Tacrolimus (0.03%) was less effectie thanhdrocortisone butrate (0.1%).32 In adults with moderate to seere atopic eczema, tacrolimusointment (0.1%) was more effectie than a combined TCS regimen (hdrocortisone acetate(1%) on face and hdrocortisone butrate (0.1%) on trunk and limbs) in achieing improementat 12 weeks.32

A sstematic reiew identified two RCTs comparing pimecrolimus cream (1%) with moderatepotenc and potent corticosteroids in adults with moderate to seere atopic eczema. In bothtrials pimecrolimus was significantl less effectie at three weeks in achieing clear or almostclear eczema than the TCS.33

6.2.2 CHILDREN

A sstematic reiew reported on two trials comparing tacrolimus with hdrocortisone acetate(1%) (mild potenc TCS) in children. Both 0.03% and 0.1% tacrolimus were significantl moreeffectie than the TCS in improing the condition at three weeks. The reiew did not identifan trials comparing pimecrolimus with mild corticosteroid in children.32

6.3 reDuction in uSe of topical corticoSteroiDS

In a ehicle controlled stud in patients aged 12 ears or older with head and neck eczemawho were intolerant of, or dependent on TCS, use of pimecrolimus for 12 weeks was associatedwith reersal of skin atroph.34

In the long term management of patients with atopic eczema, pimecrolimus used b adults for26 weeks proided significantl more TCS-free das than the placebo and reduced the numberof flares reuiring TCS application.35 Another RCT, in adults with moderate to seere atopiceczema, using pimecrolimus for up to a ear, found that a significant number of patients (276out of 658; 42%) could be maintained without TCS for up to a ear in the pimecrolimus group.36


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6.4 aDverSe effectS

In a sstematic reiew of RCTs the most common aderse effects of tacrolimus and pimecrolimuswere skin irritation and burning. The rate of skin burning was greater than with TCS.32 Anon-statisticall significant trend towards increased incidence of infections when using TCIs,

particularl irall mediated, was noted in a sstematic reiew of medication safet.

26

In a sstematic reiew no eidence was identified to show that use of pimecrolimus wasassociated with skin thinning.33 Furthermore, an RCT demonstrated that pimecrolimus cream(0.1%) ma reerse TCS induced skin atroph.34 Similarl, long term treatment (one ear) withtacrolimus ointment in atopic eczema appears non-atrophogenic and ma also reerse TCSinduced skin atroph, although this obseration was based on a small number of patients. 37

There are significant concerns around increased risk of malignanc (including skin cancers andlmphomas) following TCI use, based on post-marketing sureillance reports.26,38 Since thesetreatments are relatiel new there is insufficient eidence to make a definitie statement onwhether patients with atopic eczema treated with a TCI are at an increased risk of deelopingmalignanc. This uncertaint around long term safet profile limits the use of TCIs to moderateand seere AE and to a second line therap.

6.5 Maintenance tHerapy

In adults, 12 month maintenance therap, appling 0.1% tacrolimus ointment twice weekl waseffectie in preenting, delaing and reducing the occurrence of atopic eczema exacerbations.39

6.6 recoMMenDationS

c t ms shd b sdd, s d s d d, sh m, m m md s m h hs b d b sds h h s ss sk mds s m h sd s, sk h.

As a precaution against the possibilit that the normal immunological response to infectionma be suppressed, topical calcineurin inhibitors should not be applied to skin whichappears actiel infected.

6 topical calcineurin inHiBitorS

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7.1 DreSSingS

NICE outlined a range of dressing tpes used in the management of atopic eczema (see Table 4).No RCTs were identified relating to the efficac of dr wrap, occlusie or medicated bandages.1

Table 4: Dressings used in the management of atopic eczema1

t dss Mhd sd

Dr wrap dressings Open-weae tubular bandage or crepe bandage used as a protectiedressing, eg to keep greas moisturisers in place.

Occlusie/semi-occlusie dressings

These include apour-permeable films and membranes andhdrocolloid dressings. The can be used oer topical preparations.Nappies, sleep suits and pamas ma also hae an occlusie effectand enhance skin penetration of topical preparations.

Medicatedbandages

Cotton bandages impregnated with a ariet of therapeuticsubstances such as tar or ichthammol. The bandages are usuallapplied oer topical preparations in a spiralling and pleated fashionin the direction of enous return. A laer of self gripping, elasticised,non-adhesie bandage is usuall needed oer the bandage (topicalpreparation) to keep it in place.

The bandages can onl be used on the limbs. The cannot beapplied to the trunk and face as the ma tighten as the dr.

Patients with non-infected moderate to seere eczema should be adised to coer affectedareas with dr wrap dressings to proide a phsical barrier to scratching and improeretention of emollient.

7.2 wet wrap treatMent

Wet wrapping generall consists of two laers of open-weae tubular bandage applied oertopical preparations. The bottom laer is soaked in warm water, sueezed out and then putonto the skin oer the topical preparation. The top laer is dr. Wet wraps can be worn undernightwear or ordinar clothes and used during the da or night. The are aailable in bandageform or as garments.1

A NICE sstematic reiew identified four small RCTs of wet wrap dressing treatment oer TCSin children. Results could not be combined due to the range of techniues and timings used,the range of TCS dilutions, the definitions of eczema seerit and lack of methodological

information proided. The reiew concluded that there is no eidence that wet wrap therapis more effectie than conentional TCS treatment in patients with mild to moderate eczema.Higher stud withdrawal rates, difficulties with application and increased use of antibioticswere reported with wet wrap therap. Obserational studies suggested that growth and boneturnoer were not affected b two week periods of use of TCS under wet wrap dressings. 1

A reiew examining two small clinical studies and published expert opinion supports the useof wet wrap treatment with diluted TCS in children with seere atopic eczema where there hasbeen a lack of response to conentional treatment. It is suggested that use should be limitedto a short term basis of up to seen das (with once dail application) to minimise potentialaderse effects of steroid absorption.40

No RCT eidence was identified on the efficac of wet wrap dressings used with emollient.

There is insufficient consistent eidence on which to base a recommendation for wet wrap usein the primar care setting.


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8.1 introDuction

Although the skin lesions of around 90% of patients with atopic eczema are colonised withStaphylococcus aureus compared to (

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9 ahsms

The role of histamine in the mechanism of itch and inflammation in atopic eczema has not etbeen clearl defined. Whilst some studies hae suggested that histamine is important in thisrespect, others hae cast doubt on its significance.42,43

Acute episodes of urticaria ma be a coexisting problem in patients with eczema and the NICEguideline on atopic eczema in children recommends the use of antihistamines where this isa problem.1

The NICE sstematic reiew identified seeral small short term trials on oral antihistamines fromwhich no conclusions could be drawn, and one large placebo-controlled RCT in children withAE aged under two ears (n=795) which examined the use of cetirizine (0.25 mg/kg twice dail)for 18 months as a preentatie interention against deelopment of asthma. As a secondaroutcome the effects of treatment on the seerit of AE were measured. There was no statisticallsignificant difference between the treatment and placebo groups at an time point, although ininfants with the most severe AE (SCORAD25 at baseline), there was a corticosteroid sparing

effect. The safet of cetirizine oer the 18 months time period was confirmed.44,45

A well designed placebo-controlled trial of fexofenadine (60 mg twice dail) in adults (n=400),gien as an adunct to topical hdrocortisone butrate (0.1%) found a rapid, small, but statisticallsignificant improement in both datime and nocturnal pruritus in the treatment group whencompared with the placebo plus TCS group.43 The safet profile of fexofenadine was deemedeuialent to that of the placebo, although the stud duration was onl one week.

There is insufficient eidence on which to base a recommendation for antihistamines in atopiceczema.

Short term bedtime use of sedating antihistamines should be considered in patients withatopic eczema where there is debilitating sleep disturbance.


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10 em s

A number of enironmental factors and irritants hae been suggested as potential triggers for thedeelopment, seerit and exacerbation of atopic eczema.1 There is little good ualit eidenceon the effects of manipulating enironmental factors in the management of atopic eczema.

10.1 HouSe DuSt Mite

A sstematic reiew of fie RCTs found a small reduction in house dust mite leels throughacuuming, use of acaricide spra and specialist bedding. The clinical benefits in themanagement of atopic eczema from this reduction is unclear.22

10.2 eXpoSure to petS

A sstematic reiew concluded that there is no eidence to ascertain whether exposure to a cator dog in the home contributes to disease flares in atopic eczema. 46

10.3 clotHing

A sstematic reiew identified two RCTs on clothing materials and their effects on the smptomsof atopic eczema. It was concluded that cotton clothing did not confer an benefits whencompared to other fabrics constructed with smooth fibres.22

Limited RCT eidence based on small studies suggests that siler coated textiles can reduce AEsmptoms, possibl ia an antibacterial effect.47-49

10.4 teMperature anD HuMiDity

No good ualit eidence was identified on the effectieness of the aoidance of extremes of

temperature or humidit in the management of patients with established atopic eczema.

10.5 irritantS

No good ualit trials were identified to address the effectieness of aoidance of irritants such aswashing powders, fabric softeners and fragranced products in the management of atopic eczema.

Where an irritant effect is suspected, patients should be adised to aoid biologicalwashing powders, fabric conditioners and fragranced products such as soaps and showergels.

10 environMental factorS

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11 D s

11.1 fooD allergy anD Dietary eXcluSion

The role of food allerg in atopic eczema remains controersial. Around 35-40% of childrenseeing a specialist for atopic eczema hae some form of food allerg.50 Although, there is anassociation between IgE mediated food allerg and atopic eczema seerit in infants, it is unclearwhether hpersensitiit to food is a maor factor in causing and maintaining atopic eczema.

A Cochrane reiew of nine RCTs inoling 421 patients, concluded that there is no benefitin the use of a milk- or egg-free diet, elemental or few-foods diet in unselected patients withatopic eczema.51 Studies were generall of poor ualit with inadeuate concealment and highdropout rates. Findings from one stud in the reiew indicated that an egg-free diet ma bebeneficial for selected infants who are IgE positie to eggs.

Detailed discussion of the management of food allerg is beond the scope of this clinicalguideline. Referral for allerg inestigation ma be appropriate where food allerg is suspected.16

c D xs s mmdd mm m sh md d .

Where there is suspicion of food allerg in infants or children with atopic eczema, generalpractitioners should refer to an allergist or paediatrician with a special interest in allerg.

11.2 infant feeDing

11.2.1 MATERNAL FOOD ANTIGEN AvOIDANCE

A Cochrane reiew of four studies concluded that maternal food antigen aoidance (through

diets excluding milk, eggs, wheat and a range of other foods) during pregnanc and breastfeeding does not hae a protectie effect on the deelopment of atopic eczema during the first18 months of life.52

a th xs ds d d bs d h dm m s s mmdd.

11.2.2 BREAST FEEDING

A meta-analsis of prospectie studies found that exclusie breast feeding for three monthsor more was protectie against the deelopment of infant atopic eczema where there was apositie famil histor of atop (OR 0.58, 95%CI 0.41 to 0.92), but in a small number of studiesin indiiduals without a famil histor of atop there was no protectie effect (OR 1.43; 95%

CI 0.72 to 2.86).53

B ps shd b dsd h xs bs d h mhs m mh h dm m h h s m hs .

11.2.3 FORMULA FEEDING

A Cochrane reiew concluded that there is no eidence of reduction in the incidence of infanteczema or prealence of childhood eczema from feeding with hdrolsed formulas rather thanexclusie breast feeding. Limited eidence from a single trial suggests that use of an extensielhdrolsed casein-containing formula as a supplement to breast feeding when compared tosupplementar use of cows milk formula ma protect against infant and childhood eczema.54

B Hdsd ms shd b d s bs mk h m.


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11.2.4 WEANING

A sstematic reiew of nine cohort studies concluded that introducing solids prior to four monthsof age ma contribute to the deelopment of eczema. Results should be iewed with caution,as there were a number of methodological biases.55

Current UK guidelines based on recommendations from the WHO recommend that weaningshould start at six months.56

11.3 fooD SuppleMentS

11.3.1 PREBIOTICS

A sstematic reiew identified two studies on the effects of supplementing infant formula withprebiotic on preenting of atopic eczema. There was heterogeneit between the studies andresults were conflicting. It is not possible to make a recommendation. 57

11.3.2 PROBIOTICS

A Cochrane reiew conducted a meta-analsis of fie studies in infants at high risk of allergicdisease and reported a reduction in infant eczema with probiotic use (relatie risk (RR) 0.82,95% CI 0.70, 0.95).58 There was significant heterogeneit across the studies in terms of patientgroups, outcomes and probiotic strain. No recommendations can be drawn.

Another Cochrane reiew found no benefit to probiotic used as a treatment in children witheczema.59 Again, heterogeneit across studies was great and no recommendation for practicecan be made.

11.3.3 MINERALS AND vITAMINS

NICE identified one small poor ualit stud on zinc supplementation in children with eczemaand one poor ualit RCT on itamin E supplementation in adults and children with eczema.1No good ualit eidence was identified on which to base an recommendation.

11 Dietary interventionS

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12.1 pSycHological anD relaXation tHerapieS

A Cochrane sstematic reiew identified one small stud comparing the effectieness ofhpnotherap and biofeedback in children with AE. The outcome measure of seerit wasunalidated and there was a high drop-out rate. The reiew described the findings of studiesof pschological interentions in adults and noted some potential benefit for habit reersaltechniues, although stressing that these are specialist interentions.17

12.2 HerBal reMeDieS

A Cochrane reiew of Chinese herbs in the treatment of patients with atopic eczema identifiedfour small poor ualit RCTs of the standardised mixture of herbs called Zemophte. Noconclusions could be drawn from the results of the studies. 60

The following good practice point is adapted from the NICE guideline on management of

eczema in children.1

Patients with atopic eczema and their parents or carers should be informed that:

the should be cautious with the use of herbal medicines and be war of an herbalproduct that is not labelled in English or does not come with information about safeusage

topical corticosteroids are deliberatel added to some herbal products intended foruse b patients with atopic eczema

lier toxicit has been associated with the use of some Chinese herbal medicinesintended to treat atopic eczema.

12.3 DeaD Sea treatMent

A small RCT (n=30) in adults with atopic eczema but without actie disease trialled bathingone arm in a Dead Sea salt solution and one in tap water for 15 minutes per da for six weeks.61There was a decrease in transepidermal water loss, a 40% decrease in skin roughness, 14%increase in stratum corneum hdration and an improement in redness in the arm regularlbathed in a solution of Dead Sea salts. In the subgroup which was found at baseline to haeeleated transepidermal water loss there was a large improement (approximatel 30%) intransepidermal water loss. The clinical applicabilit of the stud is uncertain.

12.4 otHer tHerapieS

No methodologicall robust eidence was identified on the use of acupuncture, homeopathor reflexolog in the treatment of patients with atopic eczema.


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13 ps m

This section reflects the issues likel to be of most concern to patients and their carers. Thesepoints are proided for use b health professionals when discussing atopic eczema with patients,parents and carers and in guiding the production of locall produced information materials.

13.1 cHecKliSt for proviSion of inforMation

This section explains what information patients/carers can reasonabl expect to be proidedwith at the ke stages of the patient ourne. The following checklist was designed b membersof the guideline deelopment group based on their clinical experience and their understandingof the eidence base.

Dss

Proide patients and parents or carers of children with eczema with an explanation of

what eczema is, including possible causes and, if applicable, wh other siblings do nothae the condition.

Emphasise that eczema is not infectious.

Proide reassurance that the condition can be improed through a ariet of treatmentoptions.

Proide written information on the condition.

Proide contacts details of organisations that proide support and assistance for carers ofpeople with eczema (see section 13.2).

tm

Patients or parents/carers should receie a full explanation of how to use treatments and a

demonstration of how to appl dressings (if applicable). It is essential that the understandthe instructions for each tpe of treatment prescribed to them and hae the opportunit todiscuss concerns regarding potential side effects.

Explain the importance of using emollients een when the condition is well controlled.

Proide adice on the safe use of emollients, in particular how the can cause bathingsurfaces to become slipper and how paraffin based emollients can be flammable.

Outline how and when topical treatments should be applied, for how long the can beused, and how to manage changes in seerit of the condition (flare up).

Discuss the safet of steroid treatments.

Explain how to identif infection and what to do about it.

Man patients will consider using complementar and alternatie therapies. Healthcareprofessionals should discuss the lack of eidence of effectieness of alternatie andcomplementar therapies with patients, encouraging them to tell their doctor, nurseor pharmacist what the hae been using, so that their conentional treatment can beadusted accordingl and appropriate adice gien.

13 proviSion of inforMation

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13.2 SourceS of furtHer inforMation

Bsh ass DmssWillan House, 4 Fitzro SuareLondon W1T 5HTel: 0207 383 0266 Fax: 0207 388 5263

www.bad.org.uk

The British Association of Dermatologists is the professional organisation for dermatologists inthe UK. The website proides patient information leaflets.

Bsh Sk fd4 Fitzro SuareLondon W1T 5HqTel: 0207 391 6341www.britishskinfoundation.org.uk

The British Skin Foundation is a registered charit which raises funds for skin diseaseresearch. The website proides patient information leaflets.

em SdEmail: [email protected]

Eczema Scotland promotes the work of the National Eczema Societ in Scotland.

n em SHill House, Highgate HillLondon N19 5NATel: 020 7281 3553 Helpline: 0800 089 1122 (8am to 8pm Monday to Friday)Email: [email protected]

The National Eczema Societ is a patient support organisation, offering help and information

to anone affected b eczema.

nHS chswww.nhs.uk

NHS Choices is a comprehensie healthcare information serice.


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14 imm h d

This section proides adice on the resource implications associated with implementing theke clinical recommendations, and adice on audit as a tool to aid implementation.

Implementation of national clinical guidelines is the responsibilit of each NHS Board and is anessential part of clinical goernance. Mechanisms should be in place to reiew care proidedagainst the guideline recommendations. The reasons for an differences should be assessedand addressed where appropriate. Local arrangements should then be made to implement thenational guideline in indiidual hospitals, units and practices.

14.1 recoMMenDationS witH potential reSource iMplicationS

rmmd S lk s m

Bps h m shd bdsd sds

d.

5.2.1 Reduced prescribing costs

c

t ms shd bsdd, s d sd d, sh m, mm md s m h hs b db sds hh s ss sk mds s m h sd s, skh.

6.6 Increased prescribing costs

14.2 auDiting current practice

A first step in implementing a clinical practice guideline is to gain an understanding of currentclinical practice. Audit tools designed around guideline recommendations can assist in thisprocess. Audit tools should be comprehensie but not time consuming to use. Successfulimplementation and audit of guideline recommendations reuires good communication betweenstaff and multidisciplinar team working.

The guideline deelopment group has identified the following as ke points to audit to assistwith the implementation of this guideline:

Proportion of patients diagnosed with AE who:

- are directed to or proided with written information on the condition

- hae appropriate uantities of emollient on repeat prescription

- hae had instruction on correct application of topical preparations.

Record of adice to patients on:

- recognising signs of infection

- how to deal with flares and when to re-attend the GP.

Regular reiew of TCS prescriptions in place.

14 iMpleMenting tHe guiDeline

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14.3 aDDitional aDvice to nHSScotlanD froM tHe ScottiSH MeDicineS

conSortiuM

In April 2010, tacrolimus 0.1% ointment was accepted for restricted use within NHSScotland.

Licensed indication under reiew: the maintenance treatment of moderate to seere atopic

dermatitis for the preention of flares and the prolongation of flare-free interals in adult patients(16 ears) experiencing a high freuenc of disease exacerbations (ie occurring four or moretimes per ear) who hae had an initial response to a maximum of six weeks treatment of twicedail tacrolimus ointment (lesions cleared, almost cleared or mildl affected).

SMC restriction: Use is restricted to initiation b doctors with a specialist interest and experiencein treating atopic dermatitis using immunomodulator therap (this can include generalpractitioners).

In March 2010, tacrolimus 0.03% ointment was accepted for restricted use within NHSScotland.

Licensed indication under reiew: for maintenance treatment of moderate to seere atopicdermatitis in children (aged 2-15 ears) for the preention of flares and the prolongation of flare-free interals in patients experiencing a high freuenc of disease exacerbations (ie occurring

four or more times per ear) who hae had an initial response to a maximum of six weekstreatment of twice dail tacrolimus ointment (lesions cleared, almost cleared or mildl affected).

SMC restriction: Use is restricted to initiation b doctors with a specialist interest and experiencein treating atopic dermatitis using immunomodulator therap (this can include generalpractitioners).

In August 2004 pimecrolimus was reected for use within NHSScotland.


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15 th d bs

15.1 SySteMatic literature review

The eidence base for this guideline was snthesised in accordance with SIGN methodolog. Asstematic reiew of the literature was carried out using an explicit search strateg deised b aSIGN Information Officer. Databases searched included Medline, Embase, Cinahl, PschInfo andthe Cochrane Librar. The ear range was 2004-2009. The main searches were supplementedb material identified b indiidual members of the deelopment group, including ke reiewsfrom outside the search period. Each of the selected papers was ealuated b members of thegroup using standard SIGN methodological checklists before conclusions were considered aseidence.

15.1.1 PATIENT ISSUES

At the start of the guideline deelopment process, a SIGN Information Officer conducted astandard SIGN literature search for ualitatie and uantitatie studies that addressed patient

issues of releance regarding atopic eczema, with a date range 2002-2008. A further searchwas conducted on patient and social aspects. The results of the two searches were summarisedand presented to the guideline deelopment group to inform them of ke patient issues forconsideration when deising the ke uestions. Databases searched include Medline, Embase,Cinahl and PschInfo.

15.2 recoMMenDationS for reSearcH

The guideline deelopment group was not able to identif sufficient eidence to answer allaspects of the ke uestions asked in this guideline. The following areas for further researchhae been identified:

Studies on the efficac of different formats and delier of patient information in improing

management, self care and adherence with treatment in patients with atopic eczema. Interentions to promote adherence with emollient and topical corticosteroid therapies.

15.3 review anD upDating

This guideline was issued in 2011 and will be considered for reiew in three ears. An updatesto the guideline in the interim period will be noted on the SIGN website: .s..k.

15 tHe eviDence BaSe

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16 Dm h d

16.1 introDuction

SIGN is a collaboratie network of clinicians, other healthcare professionals and patientorganisations and is part of NHS qualit Improement Scotland. SIGN guidelines are deelopedb multidisciplinar groups of practising clinicians using a standard methodolog based on asstematic reiew of the eidence. The iews and interests of NHS qualit Improement Scotlandas the funding bod hae not influenced an aspect of guideline deelopment, including the finalrecommendations. Further details about SIGN and the guideline deelopment methodolog arecontained in SIGN 50: A Guideline Deelopers Handbook, aailable at .s..k

16.2 tHe guiDeline DevelopMent group

Dr Michael Tidman Consultant Dermatologist, Royal Infirmary of Edinburgh(Chair)

Ms Karen Braithwaite Pharmacist, Aberlour Pharmacy, Moray

Ms juliet Brown Information Officer, SIGN

Mrs jane Calder Senior Dietitian, St Johns Hospital, Livingston

Miss jennifer Laden Programme Manager, SIGN

Sister janice Lowe Clinical Nurse Specialist in Dermatology, Royal Infirmary ofEdinburgh

Dr Pamela McHenr Consultant Dermatologist, Royal Hospital for Sick Children,Glasgow

Dr Mar Mealea Associate Specialist in Dermatology, Royal Hospital for SickChildren, Glasgow

Dr Oliia Schofield Consultant Dermatologist, Royal Infirmary of EdinburghDr Trace Secrett General Practitioner, Bearsden

Dr Doug Smith General Practitioner, Banchory

Sister Anne Smith Director, Eczema Scotland, and Clinical Nurse Specialist inDermatology, Royal Infirmary of Edinburgh

Ms Ailsa Stein Programme Manager, SIGN

Dr Lorna Thompson Programme Manager, SIGN

Mrs Eileen Wallace Patient Representative, Stirling

Dr Stephen Wedderburn General Practitioner, Aberdeen

The membership of the guideline deelopment group was confirmed following consultation

with the member organisations of SIGN. All members of the guideline deelopment groupmade declarations of interest and further details of these are aailable on reuest from theSIGN Executie.

Guideline deelopment and literature reiew expertise, support and facilitation were proidedb the SIGN Executie. All members of the SIGN Executie make earl declarations of interestand further details of these are aailable on reuest.

In particular, the following staff are thanked for their inolement.

Mr Euan Bremner Guideline Coordinator

Mrs Lesle Forsth Events Coordinator and Executive Secretary to SIGN Council

Mrs Karen Graham Patient Involvement Officer

Miss Katie Kerr Administrative AssistantMr Stuart Neille Publications Designer


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16.3 acKnowleDgeMentS

SIGN is grateful to the following former member of the guideline deelopment group who hascontributed to the deelopment of the guideline.

Dr Daid Haldane Consultant in Occupational Health, NHS Greater Glasgow

and Clyde

16.4 conSultation anD peer review

16.4.1 NATIONAL OPEN MEETING

A national open meeting is the main consultatie phase of SIGN guideline deelopment, atwhich the guideline deelopment group presents its draft recommendations for the first time.The national open meeting for this guideline was held on 1 October 2009 and was attendedb 157 representaties of all the ke specialties releant to the guideline. The draft guidelinewas also aailable on the SIGN website for a limited period at this stage to allow those unableto attend the meeting to contribute to the deelopment of the guideline.

16.4.2 SPECIALIST REvIEW

This guideline was also reiewed in draft form b the following independent expert referees,who were asked to comment primaril on the comprehensieness and accurac of interpretationof the eidence base supporting the recommendations in the guideline. The guideline groupaddresses eer comment made b an external reiewer, and must ustif an disagreementwith the reiewers comments. All expert referees made declarations of interest and furtherdetails of these are aailable on reuest from the SIGN Executie.

SIGN is er grateful to all of these experts for their contribution to the guideline.

Dr Peter Arkwright Senior Lecturer in Paediatric Immunology, RoyalManchester Childrens Hospital

Dr Gerard Baptist General Practitioner, Aultbea and Gairloch MedicalPractice, Ross-shire

Dr Paula Beattie Consultant Dermatologist, Royal Hospital for Sick Children,Glasgow

Mr Scott Brson Lead Specialist in Pharmaceutical Public Health, NHSGreater Glasgow and Clyde

Professor Christine Clark Chairman, Skin Care Campaign, Rossendale

Dr Iain Campbell General Practitioner, Glasgow

Dr Pam Ewan Consultant Allergist, member of Anaphylaxis WorkingGroup

Dr Niall Hndman Principal General Practitioner, Carmondean Medical Group,

Livingston

Mrs Serena Liddell Dermatology Liaison Nurse, Royal Infirmary of Edinburgh

Dr Andrew Marshall General Practitioner Principal, The Broomhill Practice,Glasgow

Dr Daid McKa Consultant Dermatologist, Royal Infirmary of Edinburgh

Dr Mini Mishra Senior Medical Officer, Primary and Community CareDirectorate, Edinburgh

Dr val Dohert Specialty Medical Adviser in Dermatology, Royal Infirmaryof Edinburgh

Dr Patrick Cadigan Registrar, The Royal College of Physicians, London

Dr Barbara jane Roemmele General Practitioner, The Clinic, Glasgow

Ms Kathleen Ross Head of Paediatric Dietetics, Royal Aberdeen ChildrensHospital

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Dr Carina venter Senior Allergy Dietitian, The David Hide Asthma andAllergy Research Centre, St Marys Hospital, Newport, Isleof Wight

Professor Hwel Williams Professor of Dermato-Epidemiology, Nottingham UniversityHospitals NHS Trust

Dr joanne Walsh General Practitioner, member of Food Allergy WorkingGroup

The following expert referees commented collectiel on behalf of the Roal College ofPaediatrics and Child Health.

Dr Carol Ewing Consultant Paediatrician, Royal Manchester ChildrensHospital

Dr venkata Paturi Consultant Paediatrician, North Tees and Hartlepool NHSFoundation Trust

Professor john Warner Professor of Paediatrics, St Marys Hospital, ImperialCollege Healthcare NHS Trust

16.4.3 SIGN EDITORIAL GROUP

As a final ualit control check, the guideline is reiewed b an editorial group including thereleant specialt representaties on SIGN Council to ensure that the specialist reiewerscomments hae been addressed adeuatel and that an risk of bias in the guideline deelopmentprocess as a whole has been minimised. All members of the Editorial group make declarationsof interest and further details of these are aailable on reuest from the SIGN Executie. Theeditorial group for this guideline was as follows.

Dr Gerard Baptist General Practitioner, Aultbea and Gairloch MedicalPractice, Ross-shire

Dr Keith Brown Chair of SIGN; Co-Editor

Dr Roberta james SIGN Programme Director; Co-EditorDr via Sonthalia British Medical Association Scottish General Practice

Committee

Dr Sara Twaddle Director of SIGN; Co-Editor

Professor Hwel Williams Professor of Dermato-Epidemiology, Nottingham UniversityHospitals NHS Trust

The following editorial reiewers commented collectiel on behalf of the Roal College ofPaediatrics and Child Health.

Dr Carol Ewing Consultant Paediatrician, Royal Manchester ChildrensHospital

Professor john Warner Professor of Paediatrics, St Marys Hospital, ImperialCollege Healthcare NHS Trust


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abbs

ae atopic eczema

Bnf British National Formularci confidence interal

eaSi Eczema Area and Seerit Index

ftu fingertip unit

Hpa hpothalamic-pituitar-adrenal

ie immunoglobulin E

Mta multiple technolog appraisal

nHS qiS NHS qualit Improement Scotland

nice National Institute for Health and Clinical Excellence

poeM Patient Orientated Eczema Measure

ql ualit of life

rct randomised controlled trial

rr relatie risk

ScoraD SCORing Atopic Dermatitis

Sign Scottish Intercollegiate Guidelines Network

SMc Scottish Medicines Consortium

tci topical calcineurin inhibitor

tcS topical corticosteroid

wHo World Health Organisation

aBBreviationS

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ax 1Summar of ke uestions used to deelop the guideline

This guideline is based on a series of structured ke uestions that, where possible, definethe population concerned, the interention (or diagnostic test) under inestigation, the tpeof comparison used, and the outcomes used to measure the effectieness of the interentions.These uestions form the basis of the sstematic literature search.

tHe Key queStionS uSeD to Develop tHe guiDeline

K sS d

s

1. Which diagnostic criteria and scoring tools are most useful in thediagnosis and assessment of seerit of atopic eczema in primar care?

3

2. What factors influence the effectieness of emollient therap inreducing the smptoms of atopic eczema?

4

3. What factors should be considered in order to maximise benefit fromthe use of topical corticosteroids in patients with atopic eczema?

5

4. What is the most appropriate usage of topical calcineurin inhibitors(tacrolimus/pimecrolimus) in the management of patients with atopiceczema?

6

5. What is the eidence that occlusie dressings are beneficial in thetreatment of patients with atopic eczema?

7

6. What is the eidence that antimicrobial measures are beneficial in thetreatment of patients with atopic eczema?

8

7. What is the eidence that sstemic antihistamines are beneficial in the

treatment of patients with atopic eczema?

9

8. What is the eidence for the management of enironmental factors inthe control of atopic eczema smptoms?

10

9. What is the eidence for the influence of dietar factors in themanagement of patients with atopic eczema?

11

10. What is the eidence for the safet and efficac of complementarand/or alternatie or aduant therapies in the management of patientswith atopic eczema?

12


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ax 2Emollient uantities

ems sb s sb k9

Bd s cms d ms () ls (m)

Face 15-30 100

Both hands 25-30 200

Scalp 50-100 200

Both arms or both legs 100-200 200

Trunk 400 500

Groins and genitalia 15-25 100

These recommended amounts are for one week, twice dail application for an adult. To keep the

skin well hdrated, leae-on emollients should be applied in adeuate amounts to sufficientlcoer dr and inflamed areas. quantities reuired will ar with the size of the patient, theseerit and extent of skin drness.

anneXeS

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ax 3Fingertip unit (FTU)

A fingertip unit is described as the amount of ointment expressed from a tube with a 5 mmdiameter nozzle, applied from the distal skin crease to the tip of the palmar aspect of the indexfinger.31,62 The following tables proide a guide to the use of FTU.

Adult fingertip unit measures for use in adults

Sk ftu ds

Face and neck 2.5

Torso and abdomen 7

Back and buttocks 7

Entire arm and hand 4

A hand and fingers (front and back) 1

Entire leg and foot 8

Adult fingertip unit measures for use in children

3-6 MontHS 1-2 year olD 3-5 yearS 6-10 yearS

Face and neck 1 1.5 1.5 2

Torso and abdomen 1 2 3 3.5

Back and buttocks 1.5 3 3.5 5

Entire arm and hand 1 1.5 2 2.5

Entire leg and foot 1.5 2 3 4.5


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rs

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