A comparative randomized clinical trial evaluating the efficacy and safety of tacrolimus versus hydrocortisone as a topical treatment of atopic dermatitis in children
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 a...
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Frontiers Media S.A.
2023-09-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2023.1202325/full |
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| author | Amal A. Mohamed Radwa El Borolossy Eman M. Salah Maha S. Hussein Nashwa M. Muharram Naglaa Elsalawy Mona G. Khalil Maha O. Mahmoud Reham Y. El-Amir Heba M. A. Elsanhory Nourelhuda Ahmed Ahmed S. Adaroas Mahmoud Montaser Amal A. El Kholy |
| author_facet | Amal A. Mohamed Radwa El Borolossy Eman M. Salah Maha S. Hussein Nashwa M. Muharram Naglaa Elsalawy Mona G. Khalil Maha O. Mahmoud Reham Y. El-Amir Heba M. A. Elsanhory Nourelhuda Ahmed Ahmed S. Adaroas Mahmoud Montaser Amal A. El Kholy |
| author_sort | Amal A. Mohamed |
| collection | DOAJ |
| description | 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) |
| first_indexed | 2024-03-11T23:11:38Z |
| format | Article |
| id | doaj.art-89ff447b2613421e9e1934c5f3775514 |
| institution | Directory Open Access Journal |
| issn | 1663-9812 |
| language | English |
| last_indexed | 2024-03-11T23:11:38Z |
| publishDate | 2023-09-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pharmacology |
| spelling | doaj.art-89ff447b2613421e9e1934c5f37755142023-09-21T07:28:55ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122023-09-011410.3389/fphar.2023.12023251202325A comparative randomized clinical trial evaluating the efficacy and safety of tacrolimus versus hydrocortisone as a topical treatment of atopic dermatitis in childrenAmal A. Mohamed0Radwa El Borolossy1Eman M. Salah2Maha S. Hussein3Nashwa M. Muharram4Naglaa Elsalawy5Mona G. Khalil6Maha O. Mahmoud7Reham Y. El-Amir8Heba M. A. Elsanhory9Nourelhuda Ahmed10Ahmed S. Adaroas11Mahmoud Montaser12Amal A. El Kholy13Department of Biochemistry and Molecular Biology, National Hepatology and Tropical Medicine Research Institute, Cairo, EgyptDepartment of Clinical Pharmacy, Faculty of Pharmacy, Ain Shams University, Cairo, EgyptDepartment of Dermatology, Andrology, Sexual Medicine and STDs, Faculty of Medicine, Helwan University, Cairo, EgyptDepartment of Dermatology and Andrology, Medical Research and Clinical Studies Institute, National Research Center Cairo, Cairo, EgyptMedical Biochemistry and Molecular Biology, Faculty of Medicine, Menoufia University, Shebin Elkom, EgyptDepartment of Clinical and Chemical Pathology, Faculty of Medicine, Cairo University, Giza, EgyptPharmacology and Toxicology Department, Faculty of Pharmacy, Modern University for Technology and Information, Cairo, EgyptBiochemistry Department, Faculty of Pharmacy, Egyptian Russian University, Cairo, EgyptDepartment of Public Health and Community Medicine, Faculty of Medicine, Cairo University, Giza, Egypt0Pharmacology and Toxicology Department, Faculty of Pharmacy, Sinai University, East Kantara Branch, El Ismailiia, Egypt1Clinical Pathology Department, Elsahel Teaching Hospital, Cairo, Egypt1Clinical Pathology Department, Elsahel Teaching Hospital, Cairo, Egypt2Department of Dermatology, Andrology and STDs, Faculty of Medicine, Minia University, Minia, Egypt3Department of Clinical Pharmacy, Faculty of Pharmacy, Ain Shams University, Cairo, EgyptBackground: 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)https://www.frontiersin.org/articles/10.3389/fphar.2023.1202325/fullatopic dermatitischildrenhydrocortisonetacrolimusinflammatory markersmEASI numbering: continuous atopic dermatitis |
| spellingShingle | Amal A. Mohamed Radwa El Borolossy Eman M. Salah Maha S. Hussein Nashwa M. Muharram Naglaa Elsalawy Mona G. Khalil Maha O. Mahmoud Reham Y. El-Amir Heba M. A. Elsanhory Nourelhuda Ahmed Ahmed S. Adaroas Mahmoud Montaser Amal A. El Kholy A comparative randomized clinical trial evaluating the efficacy and safety of tacrolimus versus hydrocortisone as a topical treatment of atopic dermatitis in children Frontiers in Pharmacology atopic dermatitis children hydrocortisone tacrolimus inflammatory markers mEASI numbering: continuous atopic dermatitis |
| title | A comparative randomized clinical trial evaluating the efficacy and safety of tacrolimus versus hydrocortisone as a topical treatment of atopic dermatitis in children |
| title_full | A comparative randomized clinical trial evaluating the efficacy and safety of tacrolimus versus hydrocortisone as a topical treatment of atopic dermatitis in children |
| title_fullStr | A comparative randomized clinical trial evaluating the efficacy and safety of tacrolimus versus hydrocortisone as a topical treatment of atopic dermatitis in children |
| title_full_unstemmed | A comparative randomized clinical trial evaluating the efficacy and safety of tacrolimus versus hydrocortisone as a topical treatment of atopic dermatitis in children |
| title_short | A comparative randomized clinical trial evaluating the efficacy and safety of tacrolimus versus hydrocortisone as a topical treatment of atopic dermatitis in children |
| title_sort | comparative randomized clinical trial evaluating the efficacy and safety of tacrolimus versus hydrocortisone as a topical treatment of atopic dermatitis in children |
| topic | atopic dermatitis children hydrocortisone tacrolimus inflammatory markers mEASI numbering: continuous atopic dermatitis |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2023.1202325/full |
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