ReportsSafety of fluticasone propionate cream 0.05% for the treatment of severe and extensive atopic dermatitis in children as young as 3 months☆,☆☆,★,★★
Section snippets
Subjects
Pediatric patients between the ages of 3 months and 5 years 11 months with extensive moderate to severe psoriasis or eczema (excluding acute self-limiting eczema) were considered for enrollment. Their condition must have been stable or worsening and must have involved at least 35% of body surface area (BSA) (not counting lesions in the diaper area for subjects who wore diapers; also excluding lesions on the eyelids, in the perioral area, in the nostrils, and in areas where corticosteroid
Study population
Fifty-one children, 32 in the younger group (age 3-35 months; median, 20 months) and 19 in the older group (age 36-70 months; median, 50 months) were enrolled, all of whom had atopic dermatitis. In the younger group, 8 children were younger than 12 months (4 were 3-6 months and 4 were 7-11 months). Demographic and baseline dermatologic characteristics are shown in Tables I and II, respectively.
Empty Cell Age 3 mo to 2 y Age 3 to 5 y Both age groups
Discussion
This phase IV open-label study demonstrated that fluticasone propionate cream 0.05% applied twice daily for 3 to 4 weeks over a large BSA (mean, 64%) has a low potential to suppress HPA axis function in children as young as 3 months of age who have moderate to severe eczema. Infrequently, HPA axis suppression can occur, and therefore periodic monitoring is appropriate in high-risk patients. Monitoring may be carried out by CST, morning plasma cortisol levels, and urine-free cortisol tests. If
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Cited by (73)
Executive summary: Japanese guidelines for atopic dermatitis (ADGL) 2021
2022, Allergology InternationalCitation Excerpt :Systemic side effects. While adrenal function suppression has been reported in some cases after the use of strong TCS,19 adrenal function suppression and growth disorders have not been observed with the use of weak rank TCS.20 If these drugs are used appropriately, less systemic side effects and higher safety can be expected.
Treatment of atopic dermatitis
2022, Allergic and Immunologic Diseases: A Practical Guide to the Evaluation, Diagnosis and Management of Allergic and Immunologic DiseasesJapanese guidelines for atopic dermatitis 2020
2020, Allergology InternationalFluticasone in mild to moderate atopic dermatitis relapse: A randomized controlled trial
2018, Allergologia et ImmunopathologiaCitation Excerpt :Moreover, children are therapeutic orphans and drug investigation is necessary.10 Fluticasone is a well-known corticoid which has demonstrated efficacy and security in children when it is used topically in skin disease.1,5,6,8,11 Glazenburg et al.12 had described the fluticasone efficacy in the prevention of flare in children with moderate to severe AD using ointment; the difference with the present study is the severity of the disease and the pharmaceutical preparation.
Safety of topical medications in the management of paediatric atopic dermatitis: An updated systematic review
2023, British Journal of Clinical Pharmacology
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Supported by Glaxo Wellcome Inc.
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Conflict of interest: None.
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Reprint requests: Sheila Fallon Friedlander, MD, Department of Pediatrics and Medicine (Dermatology), University of California, San Diego School of Medicine and Children's Hospital, San Diego, 3030 Children's Way, Suite 408, San Diego, CA 92123.
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*A complete list of the members of the Fluticasone Pediatrics Safety Group appears at the end of the article.