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Ultravate lotion
通用名称
halobetasol propionate
儿科标签批准日期
2020/8/27 0:00:00
特定指示/秒
Plaque psoriasis to pediatric patients 12 years and older
标签更改摘要
- Safety and effectiveness for the treatment of moderate to severe plaque psoriasis have been established in patients 12 years of age and older.
- It is supported by evidence from adequate and well-controlled trials in adults and from one uncontrolled safety trial in 16 adolescents (12 to less than 17 years of age). Adolescent patients with moderate to severe plaque psoriasis covering a minimum of 10% of the total body surface area were treated twice daily for 2 weeks with Ultravate lotion.
- Hypothalamic-pituitary adrenal (HPA) axis function (ACTH stimulation test) was evaluated in a subset of 14 patients. After 2 weeks of treatment, 1 of 14 patients (7%) experienced laboratory evidence of adrenal suppression (i.e., cortisol serum level of ≤18 µg/dL) that recovered upon retest.
- No other adverse reactions were reported in the study.
- Because of higher skin surface area to body mass ratios, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing’s syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment.
- Adverse reactions including striae have been reported with use of topical corticosteroids in infants and children. HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids.
- Information on adverse reactions, and clinical trial.
学习类型
Safety,Pharmacokinetic
研究设计
Multicenter,Open-Label