Study |
Methods |
Participants |
Interventions |
Outcomes |
Notes |
Boguniewicz 2001[7] |
D: Cross-over AC: Unclear RS: Unclear B: Participant ITT: Yes |
2HS, two centres, U.S.A. Incl: Moderate/severe AD with S. aureus cultured from skin Excl: Overt skin infection Age: 6–58 Randomized: 20 M/F: 9/11 Evaluable: 20 |
T1: Cefuroxime axetil orally (dose not stated) twice daily vs. T2: placebo orally twice daily given for 2 weeks each with 1 week washout in between |
1. Colony counts from two involved areas and inguinal area |
Outcomes not clear |
Breneman 2000[13] |
D: Parallel AC: Unclear RS: Unclear B: Participant ITT: Not stated |
Single centre, U.S.A. Incl: AD Excl: Not stated Age (mean): 35 (M), 34·6 (F) Randomized: 50 M/F: 15/35 Evaluable: Not stated |
T1: Soap containing triclocarban 1·5% vs. T2: placebo soap. Whole body washed daily for 42 days |
1. Change from day 0 to days 14, 28, 42 as assessed by investigator (–5 = severe worsening, 5 = total clearing) 2. Mean log CFU of S. aureus at 0, 2, 4, 6, 9 weeks |
Participants also used standard moisturizer and 0·025% triamcinolone acetonide cream as required. Patient rating on itching, % with S. aureus isolated and % of body surface area affected stated as outcome but not reported in results |
Ewing 1998[14] |
D: Parallel AC: By drug company RS: Unclear B: Participant ITT: No |
2HS, single centre, U.K. Incl: AD with no sign of bacterial infection, treated with topical steroids, age 1–16 years, regular outpatient attendance Excl: Systemic steroids (past 4 weeks), systemic or topical antibiotics (past 3 weeks) Age: T1 = 7·5, T2 = 5·2 Randomized: 50 M/F: Not stated Evaluable: 46 |
T1: Flucloxacillin 250 mg vs. T2: placebo four times daily for 4 weeks (dose halved for < 10 years old) |
1. Patient and assessor global degree of improvement 2. Emergence of resistant organisms 3. Physician-rated severity of erythema (1–5) 4. Isolation of S. aureus from affected and nonaffected skin 5. Mean log S. aureus counts |
|
Fattah 1976[21] |
D: Within patient study (left/right comparison) AC: Unclear RS: Unclear B: None ITT: Not stated |
2HS, Egypt Incl: AD Excl: Secondary infection Age: Not stated Duration: Mean 14·5 weeks Randomized: 4 M/F: Not stated Evaluable: 4 |
T1: 0·1% halcinonide cream with 0·25% neomycin and 100 000 u g−1 nystatin vs. T2: 1% hydrocortisone; both applied three times daily for not more than 3 weeks |
1. Physician-assessed response to treatment made weekly |
The creams were different colours |
Gauger 2006[6] |
D: Parallel AC: Unclear RS: Unclear B: Investigators, patients ITT: Yes |
2HS, two centres, Germany Incl: Generalized, moderate severity, SCORAD at least 20 Excl: Topical or systemic antibiotic treatment 4 weeks prior to study Age (median): 17·56 years Randomized: 68 Evaluable: 57 [11 dropouts (T1: 2, T2: 9)] |
T1: silver-coated garment (verum), T2: placebo (cotton garment) Garments worn daily for 2 weeks Only basic skin care and ongoing therapy with topical steroids (up to class III) or oral antihistamines permitted n = 68 (T1: 37, T2: 31) |
1. SCORAD 2. Quality of life 3. Wearing comfort 4. Functionality 5. All measured at baseline, weeks 1 and 2 |
Patients did not wear study textiles during consultation to eliminate risk of recognizing patient's affiliation to the study clothes by investigator Silver-coated textiles such as verum consisted of micromesh material (82% polyamide, 18% lycra) with woven silver filaments with a silver content of 20% in total Although ITT is reported, 57 evaluable is referred to throughout the text The authors emphasize that reduction in severity scores correlated with reduction in S. aureus numbers, implying causality; however, reduction in S. aureus is more likely reduced due to improvement in eczema |
Gong 2006[15] |
D: Parallel AC: Unclear RS: Unclear B: Participant, clinician, outcome assessor ITT: No |
2HS, multicentre, China Incl: AD Excl: Severe fungal infection, other skin diseases which might disturb the diagnosis, severe systemic infection, pregnancy, lactation, diseases affecting immune function, treatment with systemic corticosteroids Age: range 2–65 Randomized: 337 Evaluable: 119 (10 dropouts and 208 with unspecified eczema) |
T1: Hydrocortisone butyrate ointment and mupirocin ointment both applied once daily vs. T2: hydrocortisone butyrate and vehicle ointment applied once daily (with 2–3 h between each application) for 28 days |
1. EASI score at start and at 28 days 2. Swabs from most severe lesion and nonlesional skin |
Performed subgroup analyses at end of study, which were not part of the predetermined outcomes |
Harper 1995[27] |
D: Cross-over AC: Unclear RS: Computer-generated random code B: Unclear ITT: No |
2HS, single centre, U.K. Incl: AE, > 6 months old Excl: Systemic or topical antibiotics or systemic steroids within 2 weeks of study Age: Mean 4·5 (range 1–9) Randomized: 30 M/F: 9/17 Evaluable: 21 |
T1: Oilatum Plus vs. T2: Oilatum 15 mL in an 8-inch bath of water, soak for 10–15 min daily for 4 weeks |
1. Global impression/change 2. Patients rating of skin 3. Adverse events 4. Total score in scale (Costa et al.) |
|
Hizawa 1998[8] |
D: Within patient study (L/R comparison) AC: Unclear RS: Drawing lots B: Outcome assessor ITT: Yes |
2HS, single centre, Japan Incl: Mild to moderate AD with similar eczema in bilateral elbow fossae Excl: Skin infection showing pus on exudate Age: 12–29 Randomized: 15 M/F: 3/12 Evaluable: 15 |
T1: Povidone–iodine 10% vs. T2: unspecified placebo; applied twice daily for 1 week |
1. VAS of symptoms rated by dermatologists and patients 2. Itch rated on VAS 3. Colony counts of S. aureus from elbow lesions |
|
Hjorth 1985[9] |
D: Within patient study (L/R comparison) AC: Unclear RS: Unclear B: Participant ITT: Yes |
2HS, three centres, Denmark Incl: AD Excl: < 2 years old, pregnancy No separate data on age/sex/duration for AD Randomized: 60 Evaluable: 60 |
T1: 0·1% betamethasone 17-valerate plus 2% microcrystalline fusidic acid (Fucibet) vs. T2: 0·1% betamethasone 17-valerate (Betnovate) Applied twice daily for 7 days |
1. Global degree of improvement 2. Adverse events 3. Sensitivity to fusidic acid 4. Isolation rate of S. aureus |
Results taken from a larger study of 'symmetrical steroid responsive dermatoses' |
Holland 1995[28] |
D: Parallel group AC: Unclear RS: Unclear B: Unclear ITT: No |
2HS, single centre, U.K. Incl: Moderate or severe AE with S. aureus present on skin Excl: use of bath emollients, antiseptic bath additives or medicated soaps in past 2 weeks; systemic or topical antibacterials or oral steroids in last month Age: Mean 17·3 (range 4–34) Duration: Not stated Randomized: 15 M/F: 6/9 Evaluable: Not clear |
T1: Oilatum Plus (containing triclosan and benzalkonium chloride) vs. T2: Oilatum 15 mL in 8 inches of water, from 10 to 15 min soak daily for 4 weeks |
1. Composite scale of Staughton et al. 2. William and Kligman scrub method for nonlesional and lesional skin |
|
Huang 2009[20] |
D: Parallel AC: Unclear RS: Block randomization, generated by statistician ITT: No |
Single centre, U.S.A. Incl: Children with moderate/severe AD and signs of bacterial skin infection Excl: Current or recent use of topical/oral antibiotics, allergy to cephalosporins or mupirocin Age (mean ± SD): T1: 8 ± 5, T2: 6·3 ± 4·5 Randomized: 31 M/F: T1 = 7/8, T2 = 8/8 Evaluable: 22 at end of study |
All patients received cefalexin (50 mg−1 kg−1 daily) divided into three daily doses for 2 weeks to treat staphylococcal infections T1: bleach bath (final concentration 0·005%), T2: placebo Participants bathed for 5–10 min, twice weekly T1: Participants and household members applied (T1) ointment or petrolatum (T2) intranasally twice daily for 5 consecutive days Treatment duration 3 months |
1. EASI at 1 and 3 months 2. Bacterial cultures of the nares and the worst (overtly infected) lesion at baseline, 1 and 3 months 3. Adverse events 4 Compliance |
Each participant maintained a stable regimen of topical anti-inflammatory medication and emollient therapy throughout the 3-month period. EASI scores different at baseline, T1: 26·9, T2: 17·7 |
Hung 2007[17] |
D: Parallel AC: Unclear RS: Unclear ITT: Unclear |
2HS, single centre, Taiwan Incl: Moderate/severe AD with no clinical signs of overt secondary infection Excl: Use of systemic/topical antibiotics or steroids within 4 weeks prior to study Age (mean): 15·6 years Randomized: 60 Two patients in T4 dropped out due to intolerance to a burning sensation. Two patients dropped out of T2 and two dropped out of T1 due to poor compliance |
T1: 0·05% fluticasone propionate cream vs. T2: 0·03% tacrolimus ointment vs. T3: fluticasone and 2% fusidic acid vs. T4: tacrolimus and 2% fusidic acid All twice daily for 8 weeks Comparison of interest for the review was T3 vs. T1 and T4 vs. T2 |
1. Both nostrils examined for S. aureus colonization at baseline and total serum IgE, SEA- or SEB-specific IgE measured 2. S. aureus cultures taken from designated skin lesion at baseline, 2 and 8 weeks 3. SCORAD – by two separate clinicians at baseline, 2 and 8 weeks 4. Local clinical severity done using modified local SCORAD |
Use of medicated soaps or detergents was not allowed throughout the study period. Topical preparations allowed were patients' usual moisturizers. Oral antihistamine was given to all patients Four groups but just two comparisons relevant to our review. There were only 15 participants in each group, so probably underpowered |
Juenger 2006[10] |
D: Parallel AC: Closed envelopes, but not stated to be sequentially numbered or opaque RS: Randomization list by independent biometrician using statistics software B: Participant ITT: Yes |
Single centre, Germany Incl: 'Acute' AD, participants > 2 years old Excl: Acute viral infection, acute 'staphyloderma', other skin disease that could influence evaluation, ultraviolet treatment, topical or systemic immunosuppressive or immunomodulating treatment, topical or systemic antibiotics, severe generalized disease, pregnancy, female not on contraception, allergy to silver Age (median): T1: 21, T2: 25·5, T3: 20 Randomized: 30 M/F: T1: 6/4, T2: 3/7, T3: 5/5 Evaluable: 30 |
T1: Long-sleeved undershirt and long underpants with silver thread vs. T2: identical garment with polyester thread vs. T3: prednicarbate 0·25% ointment; all for 14 days |
1. Global rating of patient/carer 'overall disease control' on scale from 0 (controlled) to 3 (not controlled) 2. Asked patients with regard to adverse events 3. SCORAD at day 14 4. Skin lesional swabs – colony counts |
Participants were allowed to use as much prednicarbate ointment as they wished; those in the silver textile group used almost as much as those in the prednicarbate group whereas those in the nonsilver group barely used any Does not provide adequate data for primary outcomes for this review |
Koller 2007[26] |
D: Right/left within patient comparison AC: Unclear RS: Unclear B: Outcome assessor ITT: Unclear |
Single centre, Austria Incl: Children with mild/moderate AD Excl: Topical or systemic antibiotics and anti-inflammatory agents Age (mean): 8·1 years Randomized: 22 stratified age and severity |
T1: Continuous use of DermaSilk tubular bandages on one arm for 3 months against 2 weeks of T2: sericin-free silk fabric without AEGIS AEM 5772/5 (i.e. without antimicrobial properties of DermaSilk) on the opposite arm followed by T3: cotton bandages for remaining 10 weeks |
1. Modified SCORAD at baseline, 2, 4, 8 and 12 weeks 2. Split into intensity score and subjective score |
Interventions allocated randomly to the different arms Patients randomized by age group and disease severity Only systemic antihistamines and emollients allowed during study period Two comparisons made – first 2 weeks T1 vs. T2, weeks 2–12 T1 vs. T3 |
Korting 1994[24] |
D: Parallel AC: Unclear RS: Unclear B: Participant ITT: No |
2HS, six centres, Germany Incl: AE suggestive of heavy S. aureus colonization with > 106 CFU cm−2 Excl: Age < 12 (though varied later), infection requiring antibiotics, other severe disease, pregnant, antibiotics last 48 h Age: Not stated (> 18 years) Randomized: Unclear, 143 'recruited' M/F: 54/89 Evaluable: Unclear |
T1: Prednicarbate 0·25% cream plus didecyldimethyl–ammonium chloride 0·25% vs. T2: prednicarbate 0·25% cream applied twice daily for 5 days |
1. Doctor's opinion of efficacy 2. Presence of S. aureus at initial lesional site (William and Kligman method) |
|
Lever 1988[30] |
D: Cross-over AC: Unclear RS: Unclear B: Outcome assessor ITT: No |
2HS, single centre, U.K. Incl: AD, participants > 2 years old Excl: Potent topical steroids, topical or systemic antibiotics during past 4 weeks Age (mean): T1/T2: 22·4 (2–52), T2/T1: 20·4 (2–56) Duration: Not stated Randomized: 49 M/F: T1/T2 12/12, T2/T1 12/9 Evaluable: 45 |
T1: 2% mupirocin ointment followed by T2: placebo (polyethylene glycol ointment) or vice versa Daily for 2 weeks |
1. Emergence of resistant organisms 2. Adverse events 3. Isolation rates of S. aureus |
Provides lots of data, but not corresponding to our outcomes |
Leyden 1977[2] |
D: Parallel AC: Unclear RS: Unclear B: Unclear ITT: Unclear |
2HS, single centre, U.S.A. Incl: Unclear; not used antibacterial soaps or antibiotic therapy for previous month Excl: None stated Age: Not stated Randomized: 36 M/F: Not stated Evaluable: 36 |
T1: fluocinolone acetonide plus 0·5% neomycin sulphate (Neo-synelar) cream vs. T2: fluocinolone acetonide (Synelar) cream applied twice daily for 1 week |
1. Pruritus score (0–3) 2. Improvement in erythema, lichenification, oozing and crusting, scaling (scored 0–3, then graded % reduction – unclear to what this refers) 3. Change in isolation rate of S. aureus 4. Change in bacterial counts of S. aureus |
Two studies were reported in this paper; only study I was included as study II did not have proper controls |
Masako 2005[11] |
D: Within patient study (R/L comparison) AC: Unclear RS: Unclear B: Participant, outcome assessor ITT: Yes |
Single centre, Japan Incl: Mild/moderate AD, (n = 17) Excl: None stated Age (mean): 29·8 years |
T1: FX cream: 0·2% farnesol plus 5% xylitol cream vs. T2: placebo cream (identical in appearance) for 7 days to L or R arms |
1. Scores of dryness and scaling 2. Change in CFU of S. aureus using stamp bottle method |
There were no losses to follow-up or adverse events |
Nilsson 1992[25] |
D: Parallel group AC: Unclear RS: Unclear B: Unclear ITT: No |
2HS, single centre, Sweden Incl: Moderate/severe AD Excl: Skin infection requiring oral antibiotics Age: Unclear Randomized: 30 M/F: Not stated Evaluable: 28 |
T1: Betamethasone plus neomycin cream vs. T2: clobetasol cream; applied to all affected areas except face twice daily for 1 week, then once daily for 1 week |
1. Patient global scale (up to 8) 2. Changes in individual signs of one area (graded 0–3) 3. Isolation of S. aureus from most severe lesion 4. Density of S. aureus from most severe lesion |
|
Polano 1960[22] |
D: Cross-over with four periods AC: Identical tubes pre-prepared by pharmacy RS: Unclear (selection of a card) B: Clinician, outcome assessor ITT: No |
2HS, single centre, the Netherlands Incl: Neurodermatitis without apparent secondary infection, having failed to react to standard treatment of outpatient department Excl: None stated Age: Not stated Duration: 'Longstanding' Randomized: 24 M/F: Not stated Evaluable: 14 |
T1: Metiderm (0·5% prednisolone plus 0·5% neomycin) vs. T2: 0·5% prednisolone vs. 1% hydrocortisone vs. petrolatum base (used in all other ointments); applied for 1 week; frequency not stated |
1. Score (0–5) for lichenification, redness, weeping, crusting, apparent secondary infection |
Outcomes were pooled without giving primary data, thus not fulfilling outcome measures |
Ramsay 1996[23] |
D: Parallel AC: Unclear RS: Unclear B: Unclear ITT: No |
2HS, number of centres unclear, Canada Incl: Mild/moderate AD amenable to treatment with topical steroid, age > 3 years Excl: Systemic steroids or antibiotics, topical antibiotics or 'other effective topical therapy' (past 7 days) Age: Not stated Randomized: 186 M/F: Not stated Evaluable: 154 |
T1: Fucidic acid 2% plus 1% hydrocortisone cream vs. T2: 1% hydrocortisone cream for 2 weeks; frequency not stated |
1. Patient severity score (0–3) 2. Investigator global response 3. Adverse events 4. Absent (0), mild (1), moderate (2), severe (3) for each of erythema, scaling, oedema, discharge, crusting 5. Lesional swabs |
Reported two studies. Study II (comparing topical 2% fusidic acid) excluded as pooled data from study I. Unclear if pathogens were S. aureus |
Schempp 2003[29] |
D: Within patient study (left/right comparison) AC: Unclear RS: Unclear B: Participant ITT: No |
2HS, single centre, Germany Incl: Subacute AD with SCORAD < 80 Excl: Infectious disease, severe underlying clinical disease, cancer, poor health, dependence on alcohol/drugs, pregnancy, breast feeding, other study < 4 weeks ago, use of oral steroids < 2 weeks ago or topically < 1 week ago, current treatment with psychotropic, anti-inflammatory, antibiotic, immunomodulatory drugs Age: 30·4 ± 12·9 Randomized: 21 M/F: 10/8 Evaluable: 18 |
T1: Hyperforin 1·5% vs. T2: placebo cream; applied twice daily for 4 weeks |
1. Modified SCORAD 2. Effect on bacterial colonization with S. aureus (no. of CFU) |
Cream was manufactured to GMP standards |
Schuttelaar 2008[12] |
D: Parallel AC: Concealed packs in pharmacy RS: Computer-generated in blocks of four B: Participant, clinician, outcome assessor ITT: Yes |
2HS, single centre, the Netherlands. Incl: AD, SCORAD > 35, > 18 years Excl: Investigational drugs, NSAIDs, light therapy, systemic steroids or topical/systemic antibiotics past 4 weeks, topical steroids > class I or tar past 7 days, known hypersensitivity to drug, pregnant, breast feeding Age: T1: 36·8, T2: 31·1 Randomized: 44 M/F: T1: 8/14, T2: 5/17 Evaluable: 44 |
T1: 3% tetracycline + 0·1% triamcinolone acetonide in oculentum simplex FNA T2: 0·1% triamcinolone in oculentum simplex FNA Applied all over body twice daily for 2 weeks |
1. Severe and minor adverse effects 2. Global change in SCORAD and SASSAD 3. Isolation rates of S. aureus |
|
Stinco 2008[18] |
D: Right/left comparison AC: Unclear RS: Computer-generated B: Clinicians, patients/parents ITT: Unclear |
2HS, single centre, Italy Incl: AD on arms without any sign of infection Excl: Acute infections, neurological or psychiatric disorders, autoimmune disease and immune defects Age (mean): 14·2 ± 7·7 Randomized: 30 Evaluable: 26 Four patients withdrew due to excessive distance from centre or personal reasons |
Right/left comparison of tubular sleeves. Each pair consisted of a sleeve with a red seam and one with a green seam. One of the colours indicated that the sleeve had been treated with AEGIS AEM 5772/5 |
1. Photographs 2. Local SCORAD index adapted for arm 3. Parent/patient assessment of pruritus using VAS |
Randomization was used to determine which arm to dress with the red- or green-coded sleeve. Use of two colours could have unblinded patients |
Wachs 1976[19] |
D: Parallel AC: Unclear RS: Unclear B: Unclear ITT: No |
2HS, single centre, U.S.A. Incl: Clinically infected, moderate/severe AD Excl: Pregnant, age < 1 year, renal disease, symptoms requiring oral antibiotics or steroids Age: Not stated Randomized: 83 M/F: Not stated Evaluable: 79 |
T1: Betamethasone valerate (Betnovate) plus gentamicin cream (BV/G) vs. T2: betmethasone valerate cream (BV) vs. gentamicin cream (G) Applied three times daily for 22 days |
1. Physician-graded global assessment 2. Erythema, pustules, crusting, exudate, vesiculation, lichenification 3. Swabs |
|
Weinberg 1992[16] |
D: Parallel AC: Unclear RS: Unclear B: Unclear ITT: No |
2HS, South Africa Incl: S. aureus super-infected AD Excl: Cefadroxil-resistant organisms, 'concomitant medications that could have affected the variables being measured' Age: T1: 4·1, T2: 4·4 Duration (years): T1: 3·2, T2: 2·6 Randomized: 33 (T1: 16, T2: 17) M/F: T1: 7/6, T2: 7/10 Evaluable: T1: 13, T2: 17 |
T1: Cefadroxil 50 mg−1 kg−1 daily in two equal doses vs. T2: placebo for 2 weeks |
1. Patient- and physician-rated global evaluations 2. Adverse events 3. Pruritus 4. Skin swab sensitivity from three sites 5. Changes in erythema and peeling 6. Isolation of S. aureus |
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