An Open-label Adrenal Suppression Study of 0.1% Fluocinonide Cream in Pediatric Patients With Atopic Dermatitis

Schlessinger, Joel; Miller, Bruce; Gilbert, R. D.; Plott, R Todd

doi:10.1001/archderm.142.12.1568

Cited by 32 publications

(21 citation statements)

References 6 publications

(8 reference statements)

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“…A total of 12 trials [112][113][114][115][116][117][118][119][120][121][122] were reported from 2000 onwards, with two trials reported together in one report. 113 Ten of these trials compared novel topical corticosteroids with standard topical corticosteroids and one trial 118 compared a topical corticosteroid with and without the addition of a penetration-enhancing drug.…”

Section: Studiesmentioning

confidence: 99%

“…This trial report was very short and there were very few details provided about the trial. Nine of these trials [112][113][114][115][116][117]122 compared treatments exclusively in children and three trials [118][119][120] did not report the age of the participants. Six of the trials 113,[116][117][118]121 had > 100 participants and six 112,114,115,119,120,122 had ≤ 50 participants.…”

Section: Studiesmentioning

confidence: 99%

“…Nine of these trials [112][113][114][115][116][117]122 compared treatments exclusively in children and three trials [118][119][120] did not report the age of the participants. Six of the trials 113,[116][117][118]121 had > 100 participants and six 112,114,115,119,120,122 had ≤ 50 participants. The treatment regimens varied, with one trial providing 7 days of treatment as required over an 18-week period 116 one trial providing either twice daily treatment for 8 weeks or twice daily treatment for four consecutive days per week for 8 weeks, 122 and the other trials providing continuous treatment for periods from 2 weeks to 42 days.…”

Section: Studiesmentioning

confidence: 99%

“…The treatment regimens varied, with one trial providing 7 days of treatment as required over an 18-week period 116 one trial providing either twice daily treatment for 8 weeks or twice daily treatment for four consecutive days per week for 8 weeks, 122 and the other trials providing continuous treatment for periods from 2 weeks to 42 days. [112][113][114][115][117][118][119][120] An additional four trials [123][124][125][126] were reported that compared a new active treatment against a topical corticosteroid as the 'standard treatment' comparator. These are discussed in the chapters in which the active treatments are discussed.…”

Section: Studiesmentioning

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: Studiesmentioning

confidence: 99%

Section: Studiesmentioning

confidence: 99%

Section: Studiesmentioning

confidence: 99%

Section: Studiesmentioning

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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“…In a separate study of two-week fluocinonide 0.1% cream treatment in pediatric subjects with atopic dermatitis, there was no evidence of HPA axis suppression on CST testing in any subject with QD application, even in children <2 years of age. 22 In addition to lower drug exposure, once-daily application may improve adherence and enhance therapeutic efficacy in patients of all ages. A meta-analysis of 11 studies of patients with skin disorders found that mean adherence to the prescribed treatment was 77 percent.…”

Section: Discussionmentioning

confidence: 99%

Daily application of fluocinonide 0.1% cream for the treatment of atopic dermatitis

2010

Journal of the American Academy of Dermatology

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[ O R I G I N A L R E S E A R C H ] ABSTRACTObjective: To assess the efficacy and safety of topical fluocinonide 0.1% cream for the treatment of atopic dermatitis. Design: In this double-blind, vehicle-controlled study, patients were randomized to receive treatment with fluocinonide 0.1% cream applied once (n=109) or twice daily (n=102) or vehicle applied once (n=50) or twice daily (n=52) for two weeks. Setting: Multicenter, outpatient. Participants: Patients aged 18 years or older with atopic dermatitis affecting at least two percent but less than 10 percent of body surface area. Measurements: Efficacy and safety measures included lesion severity, pruritus, hypothalamic-pituitary-adrenal axis suppression, and adverse events. Results: Fluocinonide 0.1% cream applied once or twice daily was more effective than cream vehicle. Both regimens were similarly efficacious after two weeks of treatment. At the end of treatment, lesions were cleared or almost cleared in 59 percent of subjects treated once daily and 57 percent of subjects treated twice daily with fluocinonide 0.1% cream. Further, considerable residual benefit remained after cessation of twice-daily versus once-daily treatment. Skin safety evaluations showed no significant adverse effects of treatment on signs or symptoms of skin atrophy. Fluocinonide 0.1% cream and vehicle treatments did not differ significantly in their suppression of the hypothalamic-pituitary-adrenal axis, nor did hypothalamic-pituitary-adrenal axis suppression differ significantly following once-or twice-daily treatment with fluocinonide 0.1% cream. Fluocinonide 0.1% cream was well tolerated. Conclusion: Once-or twice-daily topical application of fluocinonide 0.1% cream for 14 days was safe and effective for treating atopic dermatitis in this adult patient population. The efficacy of once-daily application was comparable to twice-daily application. (J Clin Aesthetic Dermatol. 2009;2(9):24-32.) A topic dermatitis is a chronic disease with acute flare-ups and periods of remission. It is often the first manifestation of a group of allergic disorders that includes asthma, allergic rhinitis, and food allergy.

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Suppression of the HPA Axis in Pediatric Patients With Atopic Dermatitis

Ishay¹

2007

Arch Dermatol

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An Open-label Adrenal Suppression Study of 0.1% Fluocinonide Cream in Pediatric Patients With Atopic Dermatitis

Cited by 32 publications

References 6 publications

Scoping systematic review of treatments for eczema

Scoping systematic review of treatments for eczema

Daily application of fluocinonide 0.1% cream for the treatment of atopic dermatitis

Suppression of the HPA Axis in Pediatric Patients With Atopic Dermatitis

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