Efficacy and safety of fluticasone propionate 0.005% ointment in the long‐term maintenance treatment of children with atopic dermatitis: Differences between boys and girls?

Glazenburg, Eltjo J.; Wolkerstorfer, Albert; Gerretsen, Anton L.; Mulder, Paul; Oranje, Arnold P.

doi:10.1111/j.1399-3038.2008.00735.x

Cited by 68 publications

(71 citation statements)

References 12 publications

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“…Two trials 105,106 reported that skin atrophy was not seen; however, one trial 108 reported that two participants showed skin changes often seen before atrophy (telangiectasia). Overall, a small number of adverse events assessed as being related to the trial medication were reported.…”

Section: Proactive Treatment Regimensmentioning

confidence: 99%

“…There was enough detail about the method of randomisation to allow assessment of the risk of bias in only six 97,102,103,107,108,110 out of 14 trials and all were assessed as being at low risk. There was enough detail about the method used to generate the allocation sequence to allow assessment of the risk of bias in only one 97 out of the 14 trials and this was assessed as low risk.…”

Section: Assessment Of Risk Of Bias For the New Studiesmentioning

confidence: 99%

“…Fourteen new trials [97][98][99][100][101][102][103][104][105][106][107][108][109][110] have been reported since 2000. Fluticasone was compared against placebo in four of the trials 98,[106][107][108] and hydrocortisone butyrate was compared against placebo in two of the trials.…”

Section: (See Appendix 3)mentioning

confidence: 99%

“…Fluticasone was compared against placebo in four of the trials 98,[106][107][108] and hydrocortisone butyrate was compared against placebo in two of the trials. 101,103 Placebo-controlled trials were reported for fluocinonide, 104,110 fluocinolone acetonide, 97 triamcinolone acetonide, 100 desonide, 99 methylprednisolone aceponate, 105 clobetasol propionate 109 and betamethasone 17-valerate in combination with fusidic acid.…”

Section: (See Appendix 3)mentioning

confidence: 99%

“…[97][98][99][100][101][102][103][104]109,110 Proactive treatment regimens A proactive treatment regimen was used in four of trials, [105][106][107][108] which involved an initial period (4 weeks) of more intensive treatment to stabilise or clear the eczema followed by 16 weeks of treatment for only 2 consecutive or evenly spread days a week.…”

Section: Reactive Treatment Regimensmentioning

confidence: 99%

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Scoping systematic review of treatments for eczema

Nankervis

Kim

Delamere

et al. 2016

Programme Grants Appl Res

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BackgroundEczema is a very common chronic inflammatory skin condition.ObjectivesTo update the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) systematic review of treatments for atopic eczema, published in 2000, and to inform health-care professionals, commissioners and patients about key treatment developments and research gaps.Data sourcesElectronic databases including MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Cochrane Skin Group Specialised Register, Latin American and Caribbean Health Sciences Literature (LILACS), Allied and Complementary Medicine Database (AMED) and Cumulative Index to Nursing and Allied Health Literature (CINAHL) were searched from the end of 2000 to 31 August 2013. Retrieved articles were used to identify further randomised controlled trials (RCTs).Review methodsStudies were filtered according to inclusion criteria and agreed by consensus in cases of uncertainty. Abstracts were excluded and non-English-language papers were screened by international colleagues and data were extracted. Only RCTs of treatments for eczema were included, as other forms of evidence are associated with higher risks of bias. Inclusion criteria for studies included availability of data relevant to the therapeutic management of eczema; mention of randomisation; comparison of two or more treatments; and prospective data collection. Participants of all ages were included. Eczema diagnosis was determined by a clinician or according to published diagnostic criteria. The risk of bias was assessed using the Cochrane Collaboration risk-of-bias tool. We used a standardised approach to summarising the data and the assessment of risk of bias and we made a clear distinction between what the studies found and our own interpretation of study findings.ResultsOf 7198 references screened, 287 new trials were identified spanning 92 treatments. Trial reporting was generally poor (randomisation method: 2% high, 36% low, 62% unclear risk of bias; allocation concealment: 3% high, 15% low, 82% unclear risk of bias; blinding of the intervention: 15% high, 28% low, 57% unclear risk of bias). Only 22 (8%) trials were considered to be at low risk of bias for all three criteria. There was reasonable evidence of benefit for the topical medications tacrolimus, pimecrolimus and various corticosteroids (with tacrolimus superior to pimecrolimus and corticosteroids) for both treatment and flare prevention; oral ciclosporin; oral azathioprine; narrow band ultraviolet B (UVB) light; Atopiclair™ and education. There was reasonable evidence to suggest no clinically useful benefit for twice-daily compared with once-daily topical corticosteroids; corticosteroids containing antibiotics for non-infected eczema; probiotics; evening primrose and borage oil; ion-exchange water softeners; protease inhibitor SRD441 (Serentis Ltd); furfuryl palmitate in emollient; cipamfylline cream; andMycobacterium vaccaevaccine. Additional research evidence is needed for emollients, bath additives, antibacterials, specialist clothing and complementary and alternative therapies. There was no RCT evidence for topical corticosteroid dilution, impregnated bandages, soap avoidance, bathing frequency or allergy testing.LimitationsThe large scope of the review coupled with the heterogeneity of outcomes precluded formal meta-analyses. Our conclusions are still limited by a profusion of small, poorly reported studies.ConclusionsAlthough the evidence base of RCTs has increased considerably since the last NIHR HTA systematic review, the field is still severely hampered by poor design and reporting problems including failure to register trials and declare primary outcomes, small sample size, short follow-up duration and poor reporting of risk of bias. Key areas for further research identified by the review include the optimum use of emollients, bathing frequency, wash products, allergy testing and antiseptic treatments. Perhaps the greatest benefit identified is the use of twice weekly anti-inflammatory treatment to maintain disease remission. More studies need to be conducted in a primary care setting where most people with eczema are seen in the UK. Future studies need to use the same core set of outcomes that capture patient symptoms, clinical signs, quality of life and the chronic nature of the disease.FundingThe National Institute for Health Research Programme Grants for Applied Research programme.

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Section: Proactive Treatment Regimensmentioning

confidence: 99%

Section: Assessment Of Risk Of Bias For the New Studiesmentioning

confidence: 99%

Section: (See Appendix 3)mentioning

confidence: 99%

Section: (See Appendix 3)mentioning

confidence: 99%

Section: Reactive Treatment Regimensmentioning

confidence: 99%

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Scoping systematic review of treatments for eczema

Nankervis

Kim

Delamere

et al. 2016

Programme Grants Appl Res

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Long-Term Use of Oral Corticosteroids and Safety Outcomes for Patients With Atopic Dermatitis

Jang,

Choi,

Lee

et al. 2024

JAMA Netw Open

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ImportanceThe use of oral corticosteroids for prolonged periods may be associated with adverse events (AEs). Nevertheless, the risk of AEs with oral corticosteroids, especially among patients with atopic dermatitis (AD), has not been comprehensively investigated and lacks evidence on duration of treatment.ObjectiveTo assess the association between long-term exposure to oral corticosteroids and AEs among adult patients with AD.Design, Setting, and ParticipantsThis nested case-control study used data from the Health Insurance Review and Assessment Service database of South Korea between January 1, 2012, and October 31, 2021, which included 1 year prior to the cohort entry date of January 1, 2013, for assessing exclusion criteria and baseline characteristics, and 1 year after the study end date of October 31, 2020, to ensure a minimum duration for assessing exposure. Among the population of adults with AD, patients diagnosed with any of 11 AEs were matched with patients who had never received a diagnosis of any of the 11 AEs.ExposureLong-term use of oral corticosteroids was defined as cumulative supply of more than 30 days or more than 90 days of oral corticosteroid prescription per year.Main Outcomes and MeasuresWe used multivariable conditional logistic regression analyses to measure the risk of 11 individual outcomes (osteoporosis, fracture, type 2 diabetes, hyperlipidemia, hypertension, myocardial infarction, stroke, heart failure, avascular necrosis, cataract, or glaucoma) as the composite outcome, controlling for potential confounders. We further classified the composite outcome to individual outcomes to evaluate the AE-specific risk.ResultsAmong 1 025 270 patients with AD between 2013 and 2020, 164 809 cases (mean [SD] age, 39.4 [14.8]; 56.9% women) were matched with 328 303 controls (mean [SD] age, 39.3 [14.7]; 56.9% women) for sex, age, cohort entry date, follow-up duration, and severity of AD, where the balance of most baseline characteristics was achieved. A total of 5533 cases (3.4%) and 10 561 controls (3.2%) were exposed to oral corticosteroids for more than 30 days, while 684 cases (0.4%) and 1153 controls (0.4%) were exposed to oral corticosteroids for more than 90 days. Overall, there was no increased risk of AEs with use of oral corticosteroids for more than 30 days (adjusted odds ratio [AOR], 1.00; 95% CI, 0.97-1.04), whereas the risk was slightly higher with use of oral corticosteroids for more than 90 days (AOR, 1.11; 95% CI, 1.01-1.23). The small elevation in experiencing an AE was observed with each cumulative or consecutive year of ever long-term use.Conclusions and RelevanceThis case-control study found a slightly increased risk of AEs associated with use of oral corticosteroids for more than 90 days per year, which warrants future research to fully elucidate the observed findings.

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