Adverse effects of topical glucocorticosteroids

Hengge, Ulrich R.; Ruzicka, Thomas; Schwartz, Robert A.; Cork, Michael J.

doi:10.1016/j.jaad.2005.01.010

Cited by 917 publications

(744 citation statements)

References 109 publications

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“…Specifically, long‐term, uninterrupted use of glucocorticoids can cause striae, increase the risk of adrenal suppression, and slow linear growth 12, 13. Calcineurin inhibitors are associated with the potential risk of malignancy (skin cancer, lymphoma), although a direct causal relationship has not been established 2.…”

Section: Discussionmentioning

confidence: 99%

Crisaborole Topical Ointment, 2% in Patients Ages 2 to 17 Years with Atopic Dermatitis: A Phase 1b, Open‐Label, Maximal‐Use Systemic Exposure Study

Zane¹,

Kircik

Call³

et al. 2016

Pediatric Dermatology

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BackgroundPhosphodiesterase‐4 (PDE4) is a promising target in atopic dermatitis (AD) treatment. The pharmacokinetics (PK), safety, and efficacy of crisaborole topical ointment, 2% (formerly AN2728) (Anacor Pharmaceuticals, Palo Alto, CA), a boron‐based benzoxaborole PDE4 inhibitor, were evaluated in children with mild to moderate AD.MethodsThis phase 1b, open‐label, maximal‐use study of crisaborole topical ointment, 2% applied twice daily (dose 3 mg/cm2) for 28 days enrolled patients ages 2 to 17 years with extensive AD involving 25% or more or 35% or more treatable body surface area, depending on age. Primary PK and safety assessments included systemic exposure to crisaborole and its metabolites after 7 days of treatment and the incidence of treatment‐emergent adverse events (TEAEs). Secondary efficacy assessments included change from baseline in Investigator Static Global Assessment (ISGA), treatment success (ISGA score ≤1 with a two‐grade or greater improvement from baseline), and improvement in five AD signs and symptoms.ResultsOf 34 patients enrolled, 31 completed the study. Crisaborole was rapidly absorbed, with limited systemic exposure between days 1 and 8. Twenty‐three of 34 patients reported one or more TEAEs; 95% were mild or moderate and one patient discontinued because of a TEAE. Mean ISGA scores declined from 2.65 at baseline to 1.15 at day 29, 47.1% of patients achieved treatment success, and 64.7% of patients achieved ISGA scores of clear (0) or almost clear 1. Mean severity scores for AD signs and symptoms declined throughout the study.ConclusionsThis open‐label study provides evidence that crisaborole topical ointment, 2% was well tolerated, with limited systemic exposure under maximal‐use conditions in patients ages 2 years and older.

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Section: Discussionmentioning

confidence: 99%

Crisaborole Topical Ointment, 2% in Patients Ages 2 to 17 Years with Atopic Dermatitis: A Phase 1b, Open‐Label, Maximal‐Use Systemic Exposure Study

Zane¹,

Kircik

Call³

et al. 2016

Pediatric Dermatology

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“…The anti-inflammatory effect of hydrocortisone is due to reduction of histamine release, reduction of IgG production and decreasing of the activity of neutrophils and macrophages [4][5][6] . Clotrimazole; 1-(o-chloro-α,α-diphenylbenzyl)imidazole is an imidazole derivative with antimycotic activity that is known to inhibit cytochrome P-450, ergosterol biosynthesis, and proliferation of cells and to interfere with cellular Ca 2+ homeostasis 7-9 .…”

Section: Introductionmentioning

confidence: 99%

“…Hydrocortisone (cortisol);11,17,20-dione, the main physiologic glucocorticoid in humans has an anti-inflammatory and an immunosuppressive effect besides its role on carbohydrate and protein metabolism 1-3 . The anti-inflammatory effect of hydrocortisone is due to reduction of histamine release, reduction of IgG production and decreasing of the activity of neutrophils and macrophages [4][5][6]imidazole is an imidazole derivative with antimycotic activity that is known to inhibit cytochrome P-450, ergosterol biosynthesis, and proliferation of cells and to interfere with cellular Ca 2+ homeostasis 7-9 . …”

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confidence: 99%

Development and Validation of HPTLC Assay Method for Simultaneous Quantification of Hydrocortisone and Clotrimazole in Cream and Applying for Stability Indicating Test

Genete

Hymete

Bekhit

2012

J. Chil. Chem. Soc.

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A simple, specific, precise and accurate simultaneous high-performance thin-layer chromatographic method of analysis for hydrocortisone and clotrimazole was developed and validated. The method employed HPTLC glass plates (20x10) mm precoated with silica gel 60 F 254 as the stationary phase. The solvent system consisted of Toluene: Propanol: Ammonia (13:3:0.1v/v) that gave compact spots with R f value of 0.27 ± 0.01 and 0.58 ± 0.02 for hydrocortisone and clotrimazole, respectively. Densitometric analysis of hydrocortisone and clotrimazole was carried out in the absorbance/reflectance mode at 226nm. The calibration curves showed good linear relationship with R 2 = 0.996 + 0.003 and 0.996 + 0.002 in the concentration range of 200-1200 and 200-1000 ng/µl for hydrocortisone and clotrimazole, respectively. The method was validated for precision, recovery and robustness. The LOD & LOQ were found to be 35.31, 107.01 and 34.93, 105.87 ng/µl for hydrocortisone and clotrimazole respectively. Statistical analysis proved that the method is repeatable, specific and accurate for the estimation of the studied drugs. Resolution of hydrocortisone, clotrimazole and their degradation products formed under different stress conditions (acid-base hydrolysis, oxidation and thermal degradation) was successfully achieved with the developed method indicating that it can be employed as a stability indicating method. Hydrocortisone (cortisol);11,17,20-dione, the main physiologic glucocorticoid in humans has an anti-inflammatory and an immunosuppressive effect besides its role on carbohydrate and protein metabolism 1-3 . The anti-inflammatory effect of hydrocortisone is due to reduction of histamine release, reduction of IgG production and decreasing of the activity of neutrophils and macrophages [4][5][6]imidazole is an imidazole derivative with antimycotic activity that is known to inhibit cytochrome P-450, ergosterol biosynthesis, and proliferation of cells and to interfere with cellular Ca 2+ homeostasis 7-9 . BACKGROUND

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“…Within the last several decades, there has been enough evidence to support the concept that AD has an immunologic basis (Leund 1997) and is associated with an increase in IgE levels (Stephen et al 1973). Although the majority of AD patient are still being treated with topical corticosteroids as the first line of treatment, there is still an pressing requirement for other anti-inflammatory drugs that can be used as an alternative to, or as an intermittent or alternating therapy during longterm treatment with topical corticosteroids because of the concern regarding long-term side effects of corticosteroid therapy (Charman et al 2000;Henge et al 2006).…”

Section: Discussionmentioning

confidence: 99%

“…However, antihistamines are associated with various side effects, the most serious of which is their sedative potential (Kay 2000). Topical corticosteroids, on the other hand, are associated with side effects such as atrophy, rosacea, acne, purpura, hyperglycaemia, glaucoma, perioral dermatitis and purpura (Arellano et al 2007;Henge et al 2006). Systemic application of corticosteroids is effective in relieving the symptoms of AD but can only be administered once or twice annually because of long-term side effects such as osteopenia and cataracts (Sidbury and Hanifin 2000).…”

Section: Introductionmentioning

confidence: 99%

A comparison of the leaf gel extracts of Aloe ferox and Aloe vera in the topical treatment of atopic dermatitis in Balb/c mice

2015

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Aloe vera gel is widely used in the treatment of an array of disturbances, especially skin disorders. The woundhealing effects have been attributed to its moisturiz-ing and anti-inflammatory effects as well as its beneficial effect on the maturation of collagen. The aim of the present study is to compare the effects of topically applied extracts of Aloe ferox with that of Aloe vera on the symptoms as well as IgE levels of a mouse model of atopic dermatitis (AD). Mice were sensitized and challenged with 2,4-dinitrochlorobenzene and treated afterwards for 10 consecutive days with the gels of either A. ferox or A. vera applied topically to the affected areas. A placebo gel was used for the control mice. Blood was collected at the beginning and end of the treatment period to measure serum IgE levels. Although the gels of both the Aloe species inhibited the cutaneous inflammatory response as well as serum IgE levels in the rats, the extracts of A. ferox were superior to that of A. vera in reducing IgE levels. The gels of A. ferox and A. vera, applied topically, may be a safe and useful alter-native to antihistamines and topical corticosteroids, for the treatment of patients suffering from recurring chronic AD.

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Adverse effects of topical glucocorticosteroids

Cited by 917 publications

References 109 publications

Crisaborole Topical Ointment, 2% in Patients Ages 2 to 17 Years with Atopic Dermatitis: A Phase 1b, Open‐Label, Maximal‐Use Systemic Exposure Study

Crisaborole Topical Ointment, 2% in Patients Ages 2 to 17 Years with Atopic Dermatitis: A Phase 1b, Open‐Label, Maximal‐Use Systemic Exposure Study

Development and Validation of HPTLC Assay Method for Simultaneous Quantification of Hydrocortisone and Clotrimazole in Cream and Applying for Stability Indicating Test

A comparison of the leaf gel extracts of Aloe ferox and Aloe vera in the topical treatment of atopic dermatitis in Balb/c mice

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