Bhatia Neal, Stein Gold Linda, Kircik Leon H., Schreiber Rhonda
J Drugs Dermatol. 2019 Aug 1;18(8):790-796.
A novel foam formulation of halobetasol propionate, 0.05% (HBP-Foam) has been developed to treat plaque psoriasis in patients who prefer a thermostable topical foam with low application shear that allows for easier coverage over large and/or hirsute areas than existing formulations. OBJECTIVE: To determine the safety and effectiveness of HBP-Foam in subjects with plaque psoriasis. METHODS: Two randomized, double-blind, vehicle-controlled clinical studies were conducted in 560 adult subjects with moderate to severe plaque psoriasis. Subjects applied the assigned test article to all psoriatic plaques twice daily for 14 days. The key efficacy measures were the proportion of subjects with “treatment success,” defined as those subjects that achieved a score of 0 (clear) or 1 (almost clear) and at least a two-grade improvement compared to baseline for the Investigator’s Global Assessment (IGA) and for the clinical signs of psoriasis (plaque elevation, scaling, and erythema) as well as pruritus. Safety measurements included adverse events and local skin reactions in the treatment area. RESULTS: HBP-Foam was statistically superior to vehicle in achieving “Treatment Success” in 25.3% and 30.7% vs 3.9% and 7.4% (P<0.001) in Studies 1 and 2, respectively. Pruritus scores statistically improved by over 30% in HBP-Foam treated subjects. In addition, these subjects experienced a significant reduction in the clinical signs of psoriasis (plaque elevation, scaling, and erythema). In contrast, in the vehicle groups the decrease in psoriasis-related signs was generally not observed. Safety outcomes were unremarkable and similar in both the HBP-Foam and vehicle treatment groups. CONCLUSIONS: These results demonstrate the safety and effectiveness of HBP-Foam in the treatment of plaque psoriasis. Furthermore, this novel foam formulation has demonstrable for its ease of application over large and/or hairy treatment areas. ClinicalTrials.gov Registration: NCT02742441 NCT02368210
已研发出一种新型的0.05%丙酸氯倍他索泡沫制剂（HBP - 泡沫），用于治疗斑块状银屑病患者，这些患者更倾向于使用一种热稳定的局部泡沫制剂，其涂抹时剪切力低，相较于现有制剂，能更轻松地覆盖大面积和/或多毛区域。
确定HBP - 泡沫在斑块状银屑病患者中的安全性和有效性。
对560名中度至重度斑块状银屑病成年患者进行了两项随机、双盲、赋形剂对照的临床研究。受试者将指定的试验药物每天两次涂抹于所有银屑病斑块上，持续14天。关键疗效指标为达到“治疗成功”的受试者比例，“治疗成功”定义为那些研究者整体评估（IGA）以及银屑病临床体征（斑块隆起、脱屑和红斑）以及瘙痒症状与基线相比达到0分（清除）或1分（几乎清除）且至少改善两级的受试者。安全性测量包括治疗区域的不良事件和局部皮肤反应。
在研究1和研究2中，HBP - 泡沫在实现“治疗成功”方面在统计学上优于赋形剂，分别为25.3%和30.7%，而赋形剂组为3.9%和7.4%（P<0.001）。在HBP - 泡沫治疗的受试者中，瘙痒评分在统计学上改善超过30%。此外，这些受试者的银屑病临床体征（斑块隆起、脱屑和红斑）显著减轻。相比之下，在赋形剂组中，通常未观察到银屑病相关体征的减轻。HBP - 泡沫和赋形剂治疗组的安全性结果均无异常且相似。
这些结果证明了HBP - 泡沫在治疗斑块状银屑病方面的安全性和有效性。此外，这种新型泡沫制剂在大面积和/或多毛治疗区域的涂抹便利性得到了证实。
ClinicalTrials.gov注册编号：NCT02742441 NCT02368210
