Taraska Victoria, Tuppal Raj, Olesen Martin, Bang Pedersen Claus, Papp Kim
The Derm Centre, Winnipeg, MB, Canada
Oshawa Clinic, Oshawa, ON, Canada.
J Cutan Med Surg. 2016 Jan;20(1):44-51. doi: 10.1177/1203475415597094. Epub 2015 Jul 29.
Fixed combination calcipotriol 50 µg/g (Cal; as hydrate) plus betamethasone 0.5 mg/g (as dipropionate; BD) has been formulated in an innovative aerosol foam.
To assess systemic safety of Cal/BD aerosol foam.
In a multicentre, single-arm, open-label, maximal-use systemic-exposure trial, adult patients with moderate to severe, extensive psoriasis (15%-30% of body surface area, including ≥30% of scalp) applied Cal/BD foam once daily. Endpoints were week 4 abnormal adrenocorticotropic hormone (ACTH) challenge test and change in albumin-corrected serum calcium, 24-hour urinary calcium excretion, and urinary calcium-creatinine ratio.
35 patients reaching week 4 exhibited normal ACTH responses. At week 4, changes in calcium homeostasis were minor and not clinically relevant; no patients experienced elevations above normal. Disease severity generally improved, and 49% of patients achieved treatment success according to the Physician's Global Assessment of Disease Severity.
No clinically relevant HPA axis or calcium homeostasis impact was observed with 4 weeks of once-daily Cal/BD foam in patients with extensive psoriasis vulgaris.
已将50μg/g的卡泊三醇（以水合物形式存在；Cal）与0.5mg/g的倍他米松（以二丙酸酯形式存在；BD）制成一种创新的气雾剂泡沫。
评估卡泊三醇/倍他米松气雾剂泡沫的全身安全性。
在一项多中心、单臂、开放标签、最大使用量全身暴露试验中，患有中度至重度广泛性银屑病（体表面积的15%-30%，包括≥30%的头皮）的成年患者每天使用一次卡泊三醇/倍他米松泡沫。观察终点为第4周的促肾上腺皮质激素（ACTH）激发试验异常以及白蛋白校正血清钙、24小时尿钙排泄和尿钙肌酐比值的变化。
35名进入第4周的患者ACTH反应正常。在第4周，钙稳态变化轻微且无临床相关性；无患者出现高于正常水平的情况。疾病严重程度总体改善，根据医生对疾病严重程度的整体评估，49%的患者治疗成功。
对于广泛性寻常型银屑病患者，每日一次使用卡泊三醇/倍他米松泡沫4周，未观察到对下丘脑-垂体-肾上腺（HPA）轴或钙稳态有临床相关影响。
