Emollients and bandages

Bibliographic informationStudy type and evidence levelNumber of patientsPatient characteristicsIntervention and comparisonFollow-up and outcome measuresEffect sizeReviewer comments
Hindley D;Galloway G;Murray J;Gardener L;

2006 Feb

249
Study Type: RCT

Evidence level: 1−
50 (45 analysed)

Wet wraps n=28

Conventional treatment n=22

Exclusions: active skin infection; previous allergic reactions to proposed trial treatment; eczema predominantly on the face
Children with atopic eczema with moderate or severe atopic eczema (SCORAD scores >15) aged 4–27 months, median age 8 months in wet wraps arm and 14 months in conventional treatment armIntervention: Wet Wraps treatment initially applied daily for 24 hours a day over hydrocortisone ointment 1% (or more potent topical corticosteroid is required) for a week, followed by wet wraps 12 to 24 hours a day depend on progress assessed by the research nurse.

When wet wraps was used for 12 hours a day the hydrocortisone 1% and emollients were used as required during the non-wet wrap peroid

Concomitant treatment:

1. a sedative antihistamine as required

2. oral antibiotics as required
Comparison: Conventional treatment: emollients applied at least 3 times a day and as required use of hydrocortisone ointment 1% twice a day (or use more potent topical corticosteroids if required) for 4 weeks
Follow-up period: 4 weeks

Outcome Measures: 1) Disease severity (mean change in SCORAD scores)

2) Quantity of topical corticosteroids used

3) Concomitant treatments (used by % children)

4) Nurse/carer ratings in
a) difference in eczema control (% better or much better)
b) ease of use of treatments (% easy to very easy to use)
c) how easy to tolerate (% easy or very easy)
1) −29 (55%) vs −24 (59%)

'Effect of allocation (effect of intervention from linear regression model after adjustment for baseline) −3.4 95% CI −12.2 to 5.5, p=0.44'

2) Mean difference −0.56g/day, 95% CI −1.9 to 0.8 g/day, p=0.404

3) Sedative antihistamines 13% vs 14%

Antibiotics 22% vs 0%, difference 22%, 95% CI 5% to 42%, p=0.05

4a) nurse rating 65% vs 59%, p=0.672
carer rating 70% vs 64%, p=0.758

4b) carer rating 39% vs 73% p=0.036

4c) carer rating 48% vs 67% p=0.239
Funding: NHS research and development fund (North West)

The study was conducted in a secondary care paediatric department.

[EL=1−] because the study was underpowered to detect clinically significant differences (the sample size in each group was only half that needed to ensure 80% power at the 0.05% level of statistical significance), the ‘education’ nurses were not blind to the treatment allocation, and only those who completed treatment were analysed.

Withdrawal rates were 5 (22%) in the wet wrap group vs 0 with control, p=0.057. Withdrawals were due to non-compliance.

One child in the wet wrap group received a potent topical corticosteroid (no further details) from days 4–7, and was subsequently withdrawn from the study
Beattie PE;Lewis- Jones MS;

2004 Jul

326
Study Type: RCT

Evidence level: 1+
19 children

Wet wraps n=10

Conventional treatment n=9

Exclusions: children requiring more potent topical corticosteroids than hydrocortisone 1%; use of oral steroids or antibiotics within 2 weeks; concurrent ues of systemic or alternative therapies
Children with atopic eczema affecting 30% or more of their body surface area, without infectious evidence.
Age 4 months to 3 years, mean 1.77 years in wet wraps arm, and 1.44 years in conventional treatment arm

Baseline SASSAD scores 28 vs 29.9
Intervention: Hydrocortisone 1% applied once in the morning for 2 weeks, with wet wraps applied twice daily for the first week and only at night for the second week. Only an emollients was used during the third week.

Emollients could be used as required for the whole duration of the study.

One finger-tip unit was spread over two hand areas.

A 20-min time delay between use of steroids and emollients

Comparison: Hydrocortisone 1% applied twice daily for 2 weeks, followed by emollients only for the third week.

Emollients could be used as required for the whole duration of the study.
Follow-up period: Duration of treatment 3 weeks

Outcome Measures: 1) SASSAD scores
a) mean change from baseline at week 2
b) mean change from baseline at week 3

2) Quantity of topical corticosteroids used (median)

3) Quantity of emollients used (median)

4) Quality of life
a) IDQOL (median change in scores at week 3)
b) DFI (median change in score at week 3)

5) Adverse effects and withdrawals
1a) −10.3 (37%) vs −15.7 (53%) 'mean fall in SASSAD was 8 more without wet wraps, 95% CI −18 to 2, p=0.11)

1b) −11.4 (41%) vs −15.7 (53%)

2) week 1: 14.9g vs 24.8g week 2: 9.3g vs 18.9 g, p=0.10

3) week 1: 285.5 g vs 199.9 g week 2: 224.5 g vs 221.5 g week 3: 200.3 g vs 257.7 g

4a) −2 vs −7, 95% CI for difference −10 to 3, p=0.24

4b) −2 vs −5, 95% CI for difference −14 to 2, p=0.42

5) 2 (20%) vs 0 folliculitis

withdrawals: 2 (20%) vs 2 (22%) due to folliculitis, unable to attend vs non-compliance, treatment failure.
Funding: The Tayside University Hospitals Trust grant scheme

The study was described as a pilot RCT.
Head and neck excluded from wet wrap therapy.

Within the quality of life assessment, changes in sleep scores were also reported (improvements in both groups), but no between-groups analysis.
Wolkerstorfer A;Visser RL;De Waard van der Spek FB;Mulder PG;Oranje AP;

2000 Nov 328
Study Type: Cohort
Non-randomised controlled trial

Evidence level: 2−
31 children

Group 1: 50% dilution of fluticasone propionate (FP) 0.05%, n=18

Group 2: a side- to-side 10%, 25% and 50% dilution of FP 0.05% for one week, then 10% dilution for one week, n=5

Group 3: 0% (emollient), 5%, 10% or 25% dilution of FP 0.05%, n=8
Children with severe refractory atopic eczema aged 5 months to 13 years, mean age not reported.

SCORAD score >40 in 29 (94%)
Intervention: Group 1: 50% dilution of FP cream under wet wrap treatment for 2 weeks

Group 2: different dilution (10%, 25% and 50%) of FP cream under wet wraps treatment for body symmetrically eczema for 2 weeks

Group 3: different dilution (0% (emollient), 5%, 10% and 25%) of FP cream under wet wraps treatment for 2 children in each strength for 2 weeks

Comparison: The serum corticol levels before and after wet wrap treatment in different dilution of FP strength groups
Follow-up period: Duration of treatment: 2 weeks

Outcome Measures: 1) Mean serum cortisol levels (SD) a) Group 1 b) Group 2 c) Group 3

2) Adverse effects a) Group 1 b) Group 2 c) Group 3
1a) Overall, no significant decrease in cortisol levels at week 2, p=0.24. Levels were 'temporarily below the normal range' (0.2–0.8 micromol/l) in 3 (17%) children

1b) 0.45 (0.17) micromol/l at week 2 vs 0.42 (0.16) at baseline

1c) levels were below the normal range in 2/8 children (0.03 and 0.09 micromol/l). Serum cortisol levels vs FP quantity per body surface area (microgram per m2) for each of the 8 patients: 0.28 vs 0 0.46 vs 0 0.55 vs 564 0.39 vs 728 0.36 vs 835 0.09 vs 957 0.03 vs 1129 0.33 vs 2071

2a) 30% (6/18) upper respiratory tract infection
30% (6/18) folliculitis
5.5% (1/18) herpes simplex infection
5.5% (1/18) diarrhoea
5.5% (1/18) itching

2b) 40% (2/5) upper respiratory infection
40% (2/5) folliculitis
20% (1/5) abdominal pain
20% (1/5) itching

2c) 63% (5/8) folliculitis
12.5% (1/8) balanitis
12.5% (1/8) furunculosis
Funding: none declared.

Tubifast was the bandage used.
The cream was applied to the whole body.
The bandage was rewetted every 2 hours with water using aspary bottle.

Cortisol was measured at 9 o'clock in the morning in groups 1 and 2, at baseline and after 2 weeks. In group 3 serum cortisol and urinary timed morning cortisol/creatinine ratio was measured daily at 6 o'clock in the morning for the first week of treatment.

SCORAD scores were also measured, but only selected numerical data were reported; results were mainly presented in graphs.

The proportions with mild, moderate and severe atopic eczema were also reported, but the method of classification was not described.
Grimalt R;Mengeaud V;Cambazard F;Study Investigators' Group.;

2007 248
Study Type: RCT Infants under 12 months randomised to topical corticosteroid plus emollient or alone

Evidence level: 1+
173 randomised; 82 to control, 91 to treatment; 162 analysed, 4 lost to follow up in control group, 5 in treatment group. 2 infants randomised to treatment group did not meet inclusion criteria.Infants less than 12 months old with moderate to severe atopic dermatitis (SOCRAD 20–70, mean 35 at baseline)

Excluded if SOCRAD<20 or SOCRAD >70 or if emollients or topical corticosteroids had been used in week prior to commencement of study. Infants older than 12 months were excluded as well as any with history of allergy to a product constituent or medical problems likely to interfere with AD evaluation.
Intervention: Topical corticosteroid plus emollient

Comparison: Topical corticosteroid alone.
Topical corticosteroids used were micronized desonide 0.1% cream or desonide 0.1% cream
Emollient used was an emollient emulsion (Exomega) containing evening primrose oil and oat extract.
Follow-up period: 6 weeks

Outcome Measures: Primary outcomes: consumption of high-potency corticosteroids, consumption of moderate-potency corticosteroids.

Secondary outcomes: severity of atopic eczema (SOCRAD score), quality of life (French version of IDQoL and DFI), tolerance and safety.
Mean weight of high-potency corticosteroid consumption after 6 weeks: 14.7g (no emollient), 8.56 (emollient) (p=0.025)

Mean weight of moderate- potency corticosteroid consumption after 6 weeks: 8.03g (no emollient), 7.43 (emollient) (p=0.92)

No significant difference in SOCRAD score was found between the treatment groups at 6 weeks.

No significant differences in quality of life were found between treatment groups.

2 patients suffered severe adverse effects and were not included in the analysis.
Data reported at 3 weeks but not reproduced here.

Topical corticosteroid prescribed according to investigators' regular practice.
Giordano-Labadie F;

2006 235
Study Type: RCT

Evidence level: 1−
Total: 76 Emollient: 37
No emollient: 39
Children aged 6 months to 12 years. SCORAD < 35Intervention: Emollient used twice daily

Comparison: Emollient vs. no emillient
Follow-up period: 8 weeks

Outcome Measures: SCORAD, pruritus, xerosis, quality of life (CLQI)
Emollient group:
CLQI reduction: 0.84 (p=0.001)
SCORAD: 59% reduction (p>0.05)
pruritus: 66% reduction (p<0.0001)
xerosis:69% reduction (p<0.01)

No emollient group:
CLQI reduction 0.41 (p=0.17)
SCORAD: 49% reduction (p>0.05)
pruritus: 42% reduction (p>0.05)
xerosis:36% reduction (p<0.01)

p<0.01 for difference between the two groups on pruritus and xerosis.
No description of randomisation, concealment, dropouts.
Schnopp C;Holtmann C;Stock S;Remling R;Folster-Holst R;Ring J;Abeck D;

2002 250
Study Type: RCT
Left-right side comparison

Evidence level: 1−
20Children aged 2–17 years ('medium' age 7.2 years), presenting at outpatients with exacerbation of atopic eczema, and skin lesions symmetrically affecting either inside of elbows or back of knees.

Medium SCORAD score 52.6 (SD 16.9), range 21.5–82.2
Intervention: Mometasone furoate 0.1% covered by wet wraps (n not stated)

Comparison: Vehicle covered by wet wraps (n not stated)
Follow-up period: Duration of treatment, 5 days

Outcome Measures: 1) SCORAD

2) Transepidermal water loss (change from baseline)

3) S aureus skin counts
1) No numerical data reported; data presented in graphs only. Statistically significantly greater reduction in mometasone group claimed, p<0.01

2) −16 (44%) mometasone vs − 12.5 (36%), p=NS

3) Data not reported
Funding: Essex Pharmaceuticals

Treatment given as hospital inpatients.
Pei AYS;Chan HHL;Ho KM;

2001 327
Study Type: RCT

Evidence level: 1−
40 randomised, 27 completed treatment and analysed

Fluticasone propionate 0.005% (diluted to 10% strength with petrolatum) n=21

Mometasone furoate 0.1% (diluted to 10% strength with petrolatum) n=19

Exclusions: treatment with systemic corticosteroids, immunosuppres sants, Chinese herbal medicine or antibiotics within 6 weeks; other skin conditions or infections
Children aged 1–15 years with atopic eczema, attending a paediatric outpatient clinic. Active disease despite treatment with a moderately potent topical corticosteroid plus soap substitutes and emollients.

Minimum disease severity score 40/144*. Baseline median scores 36.5, 41, 40, and 60.50 in groups 1, 2, 3, 4 respectively.

Disease extent scores 54 vs 70.50 (groups 3 and 4 only)

Topical skin treatment was standardised to emulsifying ointment as a soap substitute, petrolatum as emollient, and flucinolone acetonide 0.005% cream, applied twice daily
Intervention: Group 1: Fluticasone propionate 0.005% (diluted to 10% strength with petrolatum), for 4 weeks

Group 2: Mometasone furoate ointment 0.1% (diluted to 10% strength with petrolatum), for 4 weeks

Comparison: Group 3: Fluticasone propionate 0.005% (diluted to 10% strength with petrolatum), for 2 weeks, then under wet wraps for 2 weeks

Group 4: Mometasone furoate ointment 0.1% (diluted to 10% strength with petrolatum), for 2 weeks, then under wet wraps for 2 weeks

In all groups, petrolatum was applied to non- affected areas
Follow-up period:

Outcome Measures: 1) Disease severity score (change in median at week 4; p vs baseline)

2) Disease extent score (change in median at week 4; p vs baseline)

3) Subjective assessment of impact of atopic eczema on daily life (scale o-3, where 3=highest impact), p vs baseline
1) (group 1 vs 2 vs 3 vs 4 respectively)
−6.50 (18%) p=0.091
−19.0 (46%) p=0.078
−24.0 (60%) p=0.018
−46.5 (77%) p=0.050

2) Groups 3 and 4 only
−30.0 (56%) p=0.028
−48.0 (68%) p=0.025

3) Groups 3 and 4 only
+1 (6%) p=0.671
−3.5 (18%) p=0.011
Funding: none declared

[EL=1−] only completers analysed.

*Disease severity score takes account of 6 signs measured over 8 areas, using a score of 0–3 (0 none to 3 severe, and giving a maximum score of 144. The 6 signs are erythema, oedema/papulation, oozing/crusting, excoriation, lichenification, dryness).

Disease extent score estimates the body surface area involved; 8 areas are evaluated, with contributions of 9% each for three areas, 18% for four, and 1% for one.

Patients initially received the TCS for 2 weeks, then if less than 50% improvement in their condition, they were further randomised to continue with the same treatment alone, or the same under wet wraps.

At bedtime, patients applied medicated ointment to affected areas after a bath, then tubifast dressings soaked in warm water were placed over the affected areas. A second, dry, layer was placed over the wet layer. Dressings were left on overnight beofre removal in the morning.

Ten patients achieved 50% or greater improvement at week 2 therefore did not enter the second half of the study.
Three children withdrew from the study, 1 unable to tolerate the fluticasone wet wrap, 2 stopped after first week and dropped out because they 'felt eczema was static'.
Lucky AW;Leach AD;Laskarzewski P;Wenck H;
1997 Jul 245
Study Type: Cohort
Non-randomised comparative trial

Evidence level: 2−
25

Exclusions: topical corticosteroid creams not indicated; hypersensitivity to corticosteroids.
Children with mild to moderate atopic eczema, and clinically evident atopic eczema present symmetrically either on both, antecubital or popliteal fosssae or on matching areas on the extensor surfaces of the arms, legs, trunk, or cheeks.

Age 3–15 years, mean 7.8 years.
Intervention: Hydrocortisone cream 2.5% plus emollient (Eucerin), both applied once daily

Comparison: Hydrocortisone cream 2.5% applied twice daily
Follow-up period: Duration of treatment, 3 weeks

Outcome Measures: 1) Signs and symptoms of eczema (mean change in scores at 3 weeks, on scale of 0–3, none to severe)
a) erythema
b) scaling/crusting
c) excoriation
d) lichenification
e) burning/stinging
f) itching
g) global

2) Mean size of least and greatest diameters of lesions (millimetres squared)
1a) −1.4 (73% vs −1.44 (75%)
1b) −1.48 (77%) vs −1.52 (81%)
1c) −1.52 (83%) vs −1.4 (83%)
1d) −1.2 (83%) vs −1.24 (86%)
1e) −1.04 (100%) vs −1.0 (100%)
1f) −2.12 (95%) vs −2.24 (93%)
1g) −1.44 (67%) vs −1.56 (75%)

p>0.545 for ‘rates of improvement’

2) −66% vs −68% (unclear whether this applies to the total area of all lesions) p>0.98 between groups
Funding: none declared

Investigator was blind to assigned treatment.

[EL=2−] because unclear whether groups were similar at baseline - only baseline scores for global condition shown, no further details about the children.

Moisturising characteristics of the emollient were also investigated (satisfaction, ease of use) but incomplete data reported therefore data not reproduced here.

The quantities of TCS used in each group were not reported.
Harper J;

1995 241
Study Type: RCT

Evidence level: 1−
30 randomised, 26 analysed

Exclusions: concurrent use, or use within 2 weeks, of systemic or topical antibiotics or oral corticosteroids
Children aged 1–9 years (mean 4.5 years) with atopic eczema displaying features of recurrent infection and/or frequent exacerbations.

88% had at least three exacerbations in their eczema during the 12- month period prior to study entry.
Intervention: Oilatum bath emollient.
15ml was added to 8 inches of bath water, the child soaked for 10–15 minutes.

Comparison: Oilatum Plus bath emollient.
15ml was added to 8 inches of bath water, the child soaked for 10–15 minutes.
Follow-up period: Duration of treatment, 4 weeks

Outcome Measures: 1) Mean change in total clinical score* from baseline

2) Global impression scale, global change scale, self-reported diary

3) Adverse effects
1) 2.7 (SEM 2.6) Oilatum vs 9.2 (SE 2.9) Oilatum plus.
Assumed these are redcutions.
No baseline scores reported, although it was reported that the change from baseline in the Oilatum Plus group was significant, p<0.05

2) Although described as outcomes, no numerical data reported. 'No significant difference' between groups claimed.

3) n=4 vs 3 pruritus
Funding: none declared

[EL=1−] because no baseline data for main outcome, and fewer analysed than randomised.

Single centre, double-blind cross over study.

Each bath additive was used daily for 4 weeks, separated by a 2-week washout period.

Emulsifying ointment or aqueous cream were used as a soap substitute in all cases, and any pre-study topical corticosteroid therapy was continued unaltered during the study.

*total clinical score takse account of 10 signs and symptoms of eczema, and the area of the body affected; total score 100.
White MI;Batten TL;Ormerod AD;

1994 244
Study Type: Cohort within patient left-right side (arm) comparison

Evidence level: 2−
9

Exclusions: clinical infection; known allergy to emollient; atopic condition requiring systemic corticosteroid therapy
Children with chronic stable atopic eczema attending a paediatric outpatient clinic.

Aged 5 months to 13 years.

Baseline clinical scores (presented in graphs only) ranged from 1 to 7
Intervention: Daily use of bath emollient (one arm soaked in a basin of warm water with 1ml Oilatum added, for 15 minutes/day)

plus usual care (weekly bathing in bath containing 15ml emollient, twice daily application of emollient and topical corticosteroid, use of 3% aqueous emulsifying was as a soap substitute

Comparison: Usual care (weekly bathing in bath containing 15ml emollient, twice daily application of emollient and topical corticosteroid, use of 3% aqueous emulsifying was as a soap substitute)
Follow-up period: Duration of treatment, 4 weeks

Outcome Measures: 1) Mean difference in clinical score at week 4

2) Mean difference in change in clinical score over duration of study
1) 1.25 (SE 0.88), 95% CI − 0.84 to 3.34

Mean scores only presented in graphs.

2) 0.93 (SE 0.32), 95% CI 0.21 to 1.66, p=0.019
Funding: none declared

Examiner was unaware of which arm was being soaked in bath emollient daily

Clinical score takes account of extent and severity of atopic eczema. Maxium score not stated
Muzaffar F, Hussain I, et al

2002 246
Study Type: Cohort

Evidence level: 2−
50

(a left-right comparison)
Children with mild to moderate atopic eczema (SCORAD scores 15–40, mean approximately 20).
Mean age 3.5 (SD 2.5), no range reported.
Intervention: Betamethasone valerate 0.1% ointment applied in the morning to affected areas, and emollient applied in the evening (Oilatuma)

Comparison: Betamethasone valerate 0.1% ointment applied twice daily to affected areas
Follow-up period: Duration of treatment, 4 weeks Outcome Measures:

1) SCORAD (mean change in score from baseline)

2) Adverse effects
1) −17.2 (88%) vs −17.5 (88%)
'no significant difference between groups' (no p value reported)

2) None were reported during the trial
Funding: none declared, although the emollient cream was provided by Stiefel Laboratories ltd.

[EL=2−] because no baseline data were reported, therefore cannot tell whether groups were similar in all aspects other than the intervention.

The quantities of TCS used in each group were not reported.
Bibliographic informationStudy type and evidence levelAim of studyNumber of patients and patient characteristicsPopulation characteristicsOutcome measuresResults and commentsReviewer comment
Tang WYM;Chan HHL;Lam VMF;Chong LY;Lo KK;

1999 330
Intervention: Wet wraps treatment with mometasone furoate 0.1% once daily for 2 weeks, diluted to 10% or 15% using emulsifying ointment (strength used depended on age and disease severity).

Mometasone was applied to the affected areas and emulsifying ointment to all areas of dry skin of the body and limbs as an emollient.

Wet wraps were worn for 10–12 hours per day.

Comparison: N/A
12

Exclusions: systemic corticosteroid treatment, Chinese herbal medicine, or systemic immunosuppressant therapy in the preceding 3 months; extensive oozing or clinically infected eczematous lesions
Children with severe atopic eczema who failed to respond to at least 2 weeks' treatment with emollients and topical corticosteroids.

Aged 3–12 years, mean 8.5 years.
1) Clinical severity score (0–3, applied to 5 clinical signs/symptoms, erythema, papulation/oedema, excoriations, lichenification, dryness), mean change

2) Self-assessment score (0–3, applied to 4 symptoms, mood disturbance, itchiness, sleep loss, social perturbation), mean change

3) 'early morning' plasma cortisol levels (n=8)

4) Adverse effects

folliculitis
1) −7.5 (73%)

2) −6.2 (72%)

3) Within normal range in 7 of 8 children (166–773 nmol/l); below lower limit in 1 child (139nmol/l).
Change from baseline not reported.

4) 25% (n=3) folliculitis
25% 'tight sensation'
8% itchiness
8% cool sensation
8% hot and wet sensation
Funding: none declared

Dressings used were tubifast and tubigrip; 10 used tubigrip alone, 1 tubifast alone, and 1 used both.

Parents made up the diluted product at home, having been provided with the weighed ingredients to make a fresh product every night.

A 10% dilution was used in 4 children, and a 15% dilution in 8.
Cork MJ;

1998 247
EL=3Intervention: Regimen 1:
Fluprednidene-21- acetate applied twice daily days 1 and 3, emollients applied twice daily day 2 (repeated until day 21)

Regimen 2:
Fluprednidene-21- acetate applied twice daily days 1 and 4, emollients applied twice daily days 2–3 (repeated until day 21)

Regimen 3:
Fluprednidene-21- acetate applied twice daily days 1 and 5, emollients applied twice daily days 2–4 (repeated until day 21)

Comparison: Fluprednidene-21- acetate applied twice daily, wihout emollients
44It is not clear whether the patients were children or adults. They had atopic eczema. No other demographic details.1) Severity

2) Quantity of TCS used
1) No numerical data. Reported that the reduction in severity was similar in the four groups. Not stated how severity was measured.

2) The group using emollient for most days used 75% less TCS than the control group (TCS only).
This was a DB left-right side comparison.
Chamlin SL;Kao J;Frieden IJ;Sheu MY;Fowler AJ;Fluhr JW;Williams ML;Elias PM;

2002 Aug 68
EL=3Intervention: Moisturising cream three times daily plus desonide 0.5% lotion applied twice daily (left side of body)

To standardise a cleansing regimen, patients were also instructed to use a nonmedictaed cleansing bar (cetaphil)

Comparison: Control group (desonide 0.5% lotion applied twice daily, used on right side of body)

To standardise a cleansing regimen, patients were also instructed to use a nonmedictaed cleansing bar (cetaphil)
24Patients aged 6 years and above with a 'confirmed diagnosis' of mild-to-moderate atopic eczema, having erythema, dryness or scaling, and pruritus on both sides of their body.1) Symptom scores (7 signs or symptoms*, marked out of 9; maximum scores 63)

2) Global assessment of improvement (clear=100% clearance except for residual discolouration; marked improvement=75–99% improvement; definite improvement 50–74% improvement; minimal improvement =25–49% improvement;no change; and exacerbation

3) Tolerability
No numerical data for any outcome; data shown in graphs onlyFunding: Galderma Laboratories Inc., Fort Worth, Texas.

Target lesions were identified on both sides of the body; mirror lesions were preferred but not required.

*erythema, dryness or scaling, pruritus, excoriations, lichenification, oozing or crusting, and indurations or papules.

Scale 0–9: 0=none, 1–3=mild, 4–6=moderate, 7–9=severe
Cork MJ;Timmins J;Holden C;Carr J;Berry V;Tazi- Ahnini R;Ward SJ;

2003 236
EL=3Intervention: Aqueous cream (used by 71%)

Comparison: 'other' emollients (14 used; which not specified)
100Children with atopic eczema aged 1–16 years attending a paediatric dermatology clinic. No further demographic details.Proportion reporting an immediate cutaneous reaction (a report of one or more of burning, stinging, itching, and redness developing within 20 minutes of applying an emollient to the child's skin)56.3% with aqueous cream

17.8% immediate cutaneous reactions per episodes of exposure (111 for 622 episodes

Difference between aqueous cream and all other emollients grouped together statistically significant, p<0.001
Funding: none declared.

An anonymised form was completed from the children's notes and during clinic visits
Whitefield M;

1998 240
EL=3Intervention: Dermol 500 lotion, applied to the affected areas as required; could be used in the shower or bath, and instead of ordinary soap or shower gel.

Comparison: N/A
40 (39 completed)Children aged 20 months to 13 years (mean 6 years) already receiving treatment for eczema/dermatitis and known to require emollients to manage their dry skin condition.

Exclusions: acute secondary skin infection (exudative dermatitis); known or suspected history of intolerance or skin sensitivity to any of the ingredients e.g. benzalkonium chloride or chlorhexidine hydrochloride
1) Itching

2) Dryness

3) Satisfaction

4) Ease of use (cosmetic acceptability, n=34 [87%])

5) Satisfaction with the effectiveness of the lotion as a soap susbstitute (in 27 who used the product in this way)

6) Adverse effects
1) Itching of limbs/trunk (n=37): 84% better, much better or completely better, 16% unchanged.

Itching of face/neck (n=21): 86% better, much better or completely better, 14% unchanged.

2) Dryness of limbs/trunk (n=39): 87% better, much better or completely better, 13% unchanged or worse.

Dryness of face/neck (n=21): 81% better, much better or completely better, 19% unchanged.

3) Overall effectiveness described as excellent, very good or good by 95%, and poor by 5%

Of 79 comparisons with emollients used previously 72% ranked dermol 500 as better or much better, 23% 'were ambivalent', and 5% worse or much worse.

4) 24% excellent
41% very good
35% good

Of 79 comparisons with emollients used previously 77% ranked dermol 500 as better or much better, 15% 'were ambivalent', and 8% worse or much worse

5) 4% excellent
15% very good
63% good
19% satisfactory

6) No adverse effects were reported
Funding: none declared (author's address Dermal Laboratories Ltd).

Patients continued with their other systemic or topical treatments.

Dryness of the skin assessed by visual inspection; severity of itching assessed using indicators such as the overall level of distress being caused to the child and by the intensity and frequency of scratching.
Ling TC;Highet AS;

2000 243
EL=3Intervention: An antiseptic bath oil emollient containing benzalkonium cholride (6%) and triclosan (2%) (Oilatum Plus)

Comparison: none
7 (case reports), 4 of whom were children age under 12 yearsPatients with atopic eczema who had developed irritant reactions to an antiseptic bath oil emollient.Adverse effects reported by each case1) A 6.5 year old with infected atopic eczema (other treatments; antibiotics and topical corticosteroids):
on first exposure to oilatum plus, developed an erythematous desquamating rash, affecting particularly the skin flexures of the groin. Half a capful had been used in a standard sized bath filled to half the depth.
Previously used oilatum (plain) with no adverse effects

2) An 11-month old child with an infective episode that settled with potent topical steroids and oilatum plus.After 2 weeks of daily use of oilatum plus used according to the instructions, he gradually developed areas of dry, non-pruritic desquamation behind his knees. This resolved after oilatum plus was stopped.

3) A 2-year old girl presented with mild, infected atopic eczema for which she was prescribed oilatum plus and mild topical steroids. She gradually developed an irritant reaction to oilatum plus over several months, affecting the skin flexures, including the groin and the skin under the plastic of her disposable nappy. Her mother had been using an excessive amount of oilatum plus; two capfuls to only 5cm of water in a standard sized bath. The reaction settled following a change to a plain bath emollient.

4) A 2-year old boy with atopic eczema managed with emollients, topical steroids, antiseptic bath emollients and wet wrapping. He had an exacerbation of his atopic eczema while using oilatum plus; in an attempt to hasten his recovery, his mother had started to add extra capfuls of oilatum plus to the bath, after which his face was washed with the bath water. He developed erythema and scaling around his mouth and on his trunk which was worse on the skin flexures (but less itchy than his usual atopic eczema). Subsequent use of oilatum plus at the correct concentration was well tolerated with no adverse reactions.
Funding: none declared.

From: Evidence tables

Cover of Atopic Eczema in Children
Atopic Eczema in Children: Management of Atopic Eczema in Children from Birth up to the Age of 12 Years.
NICE Clinical Guidelines, No. 57.
National Collaborating Centre for Women's and Children's Health (UK).
London: RCOG Press; 2007 Dec.
Copyright © 2007, National Collaborating Centre for Women’s and Children’s Health.

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