A comparative randomized clinical trial evaluating the efficacy and safety of tacrolimus versus hydrocortisone as a topical treatment of atopic dermatitis in children

There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

Abstract

Background: Atopic dermatitis (AD) aetiology is not exactly identified, but it is characterized by pruritic skin reactions with elevation in the levels of inflammatory markers. Despite the fact that Corticosteroids are the mainstay therapy in the management of AD, they have many local and systemic adverse effects.

Objective: The aim of this study is to evaluate the efficacy and safety of topical tacrolimus ointment in comparison to topical hydrocortisone cream in the management of the AD of children diagnosed with AD.

Patients and Methods: This study was conducted on 200 children with AD. They were simply randomized into two groups, the tacrolimus group treated with 0.03% topical tacrolimus ointment and the hydrocortisone group treated with 1% hydrocortisone cream twice daily during the 3 weeks study period.

Results: At the end of the study, both the tacrolimus and hydrocortisone groups showed a significant decline in the mean serum level of IL-10, IL-17, and IL-23 ( p < 0.05) when compared to their baseline levels. However, the tacrolimus group showed a more significant decrease ( p < 0.05) in the mean serum level of IL-10, IL-17, and IL-23 as compared to the hydrocortisone group [Mean differences = 1.600, 95% CI: 0.9858–2.214; 1.300, 95% CI: 1.086–1.514 and 4.200, 95% CI: 3.321–5.079]. Moreover, the median mEASI decreased similarly from 32 to 21 in the tacrolimus group and from 30 to 22 in the hydrocortisone group ( p > 0.05) [Median difference = −2.000, 95% CI: −2.651 to −1.349; Median difference = 1.000, 95% CI: 0.3489–1.651]. Mild to moderate transient stinging and erythema were the main adverse effects that showed higher incidence in the tacrolimus group than in the hydrocortisone group ( p < 0.05). In most cases, they resolved within 3–4 days. Besides, tacrolimus ointment did not cause skin atrophy as compared to the hydrocortisone group ( p < 0.05).

Conclusion: Tacrolimus ointment is more beneficial than hydrocortisone cream in managing AD in children in terms of lowering the inflammatory markers, however, there is no difference on the dermatitis severity scale. Moreover, tacrolimus is safer with a better side effect profile compared to hydrocortisone.

Trial Registration: The trial is registered at ClinicalTrials.gov ( CT.gov identifier: NCT05324618)

Related collections

Most cited references 50

Record: found
Abstract: found
Article: not found

Guidelines of care for the management of atopic dermatitis: section 1. Diagnosis and assessment of atopic dermatitis.

Lawrence F. Eichenfield, Wynnis L. Tom, Sarah L Chamlin … (2014)

Atopic dermatitis (AD) is a chronic, pruritic, inflammatory dermatosis that affects up to 25% of children and 2% to 3% of adults. This guideline addresses important clinical questions that arise in the management and care of AD, providing updated and expanded recommendations based on the available evidence. In this first of 4 sections, methods for the diagnosis and monitoring of disease, outcomes measures for assessment, and common clinical associations that affect patients with AD are discussed. Known risk factors for the development of disease are also reviewed. Copyright © 2013 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

0 comments Cited 310 times – based on 0 reviews      Review now

Bookmark

Record: found
Abstract: found
Article: not found

Type 2 cytokines: mechanisms and therapeutic strategies.

Thomas Wynn (2015)

Type 2 immune responses are defined by the cytokines interleukin-4 (IL-4), IL-5, IL-9 and IL-13, which can either be host protective or have pathogenic activity. Type 2 immunity promotes antihelminth immunity, suppresses type 1-driven autoimmune disease, neutralizes toxins, maintains metabolic homeostasis, and regulates wound repair and tissue regeneration pathways following infection or injury. Nevertheless, when type 2 responses are dysregulated, they can become important drivers of disease. Type 2 immunity induces a complex inflammatory response characterized by eosinophils, mast cells, basophils, type 2 innate lymphoid cells, IL-4-and/or IL-13-conditioned macrophages and T helper 2 (TH2) cells, which are crucial to the pathogenesis of many allergic and fibrotic disorders. As chronic type 2 immune responses promote disease, the mechanisms that regulate their maintenance are thought to function as crucial disease modifiers. This Review discusses the many endogenous negative regulatory mechanisms that antagonize type 2 immunity and highlights how therapies that target some of these pathways are being developed to treat type 2-mediated disease.

0 comments Cited 248 times – based on 0 reviews      Review now

Bookmark

Record: found
Abstract: found
Article: not found

Adverse effects of topical glucocorticosteroids.

Ulrich Hengge, Thomas Ruzicka, Robert A. Schwartz … (2006)

Topical corticosteroids were introduced into medicine about 50 years ago. They represent a significant milestone in dermatologic therapy. Despite encouragement to report observed adverse drug reactions, the clinical practice of reporting is poor and incomplete. Likewise, adverse effects and safety of topical corticosteroids are neglected in the medical literature. The authors provide an updated review of their adverse-effect profile. Children are more prone to the development of systemic reactions to topically applied medication because of their higher ratio of total body surface area to body weight. Cutaneous adverse effects occur regularly with prolonged treatment and are dependent on the chemical nature of the drug, the vehicle, and the location of its application. The most frequent adverse effects include atrophy, striae, rosacea, perioral dermatitis, acne, and purpura. Those that occur with lower frequency include hypertrichosis, pigmentation alterations, delayed wound healing, and exacerbation of skin infections. Of particular interest is the rate of contact sensitization against corticosteroids, which is considerably higher than generally believed. Systemic reactions such as hyperglycemia, glaucoma, and adrenal insufficiency have also been reported to follow topical application. The authors provide an updated review of local and systemic adverse effects upon administration of topical corticosteroids, including the latest FDA report on the safety of such steroids in children. At the completion of this learning activity, participants should be familiar with topical corticosteroids and their proper use.

0 comments Cited 232 times – based on 0 reviews      Review now

Bookmark

All references

Author and article information

Contributors

Radwa El Borolossy: URI : https://loop.frontiersin.org/people/1850075/overview

Maha S. Hussein: URI : https://loop.frontiersin.org/people/2293517/overview

Mona G. Khalil: URI : https://loop.frontiersin.org/people/2310885/overview

Heba M. A. Elsanhory: URI : https://loop.frontiersin.org/people/2275002/overview

Amal A. El Kholy: URI : https://loop.frontiersin.org/people/1767075/overview

Journal

Journal ID (nlm-ta): Front Pharmacol

Journal ID (iso-abbrev): Front Pharmacol

Journal ID (publisher-id): Front. Pharmacol.

Title: Frontiers in Pharmacology

Publisher: Frontiers Media S.A.

ISSN (Electronic): 1663-9812

Publication date (Electronic): 20 September 2023

Publication date Collection: 2023

Volume: 14

Electronic Location Identifier: 1202325

Affiliations

[1] ¹ Department of Biochemistry and Molecular Biology , National Hepatology and Tropical Medicine Research Institute , Cairo, Egypt

[2] ² Department of Clinical Pharmacy , Faculty of Pharmacy , Ain Shams University , Cairo, Egypt

[3] ³ Department of Dermatology, Andrology, Sexual Medicine and STDs , Faculty of Medicine , Helwan University , Cairo, Egypt

[4] ⁴ Department of Dermatology and Andrology , Medical Research and Clinical Studies Institute , National Research Center Cairo , Cairo, Egypt

[5] ⁵ Medical Biochemistry and Molecular Biology , Faculty of Medicine , Menoufia University , Shebin Elkom, Egypt

[6] ⁶ Department of Clinical and Chemical Pathology , Faculty of Medicine , Cairo University , Giza, Egypt

[7] ⁷ Pharmacology and Toxicology Department , Faculty of Pharmacy , Modern University for Technology and Information , Cairo, Egypt

[8] ⁸ Biochemistry Department , Faculty of Pharmacy , Egyptian Russian University , Cairo, Egypt

[9] ⁹ Department of Public Health and Community Medicine , Faculty of Medicine , Cairo University , Giza, Egypt

[10] ¹⁰ Pharmacology and Toxicology Department , Faculty of Pharmacy , Sinai University, East Kantara Branch , El Ismailiia, Egypt

[11] ¹¹ Clinical Pathology Department , Elsahel Teaching Hospital , Cairo, Egypt

[12] ¹² Department of Dermatology , Andrology and STDs , Faculty of Medicine , Minia University , Minia, Egypt

[13] ¹³ Department of Clinical Pharmacy , Faculty of Pharmacy , Ain Shams University , Cairo, Egypt

Author notes

Edited by: Karel Allegaert, KU Leuven, Belgium

Reviewed by: Enza D’. Auria, Vittore Buzzi Children’s Hospital, Italy

Regina Fölster-Holst, University Medical Center Schleswig-Holstein, Germany

*Correspondence: Amal A. El Kholy, amal.elkhouly@ 123456pharma.asu.edu.eg

Article

Publisher ID: 1202325

DOI: 10.3389/fphar.2023.1202325

PMC ID: 10547881

SO-VID: 2b3ad386-8161-4570-9ef4-e9ac6b70a8be

License:

This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.