Sidgiddi Srinivas, Naqvi Syed Mujtaba Hussain, Shenoy Manjunath, Balraj Devang Narayan, Kothari Jayesh, Gupta Sandesh, Haq Rizwan, Mittal Rajan, Mehta Suyog, Mane Amey
Clinical Development, Dr. Reddy's Laboratories Inc., Princeton, USA.
Medical Affairs, Dr. Reddy's Laboratories Pvt Ltd, 27, Ameerpet Rd, Leelanagar, Hyderabad, Telangana, 500016, India.
Dermatol Ther (Heidelb). 2021 Oct;11(5):1717-1732. doi: 10.1007/s13555-021-00591-z. Epub 2021 Aug 28.
Clobetasol propionate (0.05% standard dose formulation), a topical corticosteroid, leads to systemic side-effects like hypothalamic-pituitary-adrenal (HPA) axis suppression at doses as low as 2 g/day. The aim of this study was to evaluate HPA axis suppression, efficacy, and safety of clobetasol propionate (0.025%, formulation 5 and 13) versus currently marketed 0.05% cream in Indian patients with moderate-to-severe psoriasis.
In this phase 2a investigator-blinded study, patients aged ≥ 18 years with moderate-to-severe psoriasis were randomized 1:1:1 to receive clobetasol propionate 0.025% formulation 5, or 13, or 0.05% cream; twice daily for 28 days. Safety endpoints included adrenocorticotropic hormone (ACTH) test results at day 28 (primary), and local tolerability at each visit (burning/stinging/pruritus, secondary). Efficacy endpoints included Psoriasis Global Assessment (PGA) score.
Overall, 88 patients received clobetasol propionate 0.025% formulation 5 and 13 (n = 29 for both) and 0.05% cream (n = 30). At day 28, the proportion of patients with an abnormal ACTH stimulation test (cortisol levels ≤ 18 µg/dl) was numerically lower in 0.025% formulations: 5 (20.7%) and 13 (17.2%) compared with 0.05% cream (30.0%), (p = 0.320). Decrease in burning/stinging /pruritus scores were comparable in all treatment groups and PGA success rates were higher with 0.025% formulations: 5 (38.9%) and 13 (36.8%) compared with 0.05% cream (30.8%).
Clobetasol propionate 0.025% could be an effective treatment for moderate-to-severe psoriasis compared with 0.05% cream, demonstrating comparable efficacy with a better systemic safety profile.
REF/2018/01/016779.
丙酸氯倍他索（0.05%标准剂量制剂）是一种外用皮质类固醇，每天低至2克的剂量就会导致下丘脑 - 垂体 - 肾上腺（HPA）轴抑制等全身副作用。本研究的目的是评估丙酸氯倍他索（0.025%，制剂5和13）与目前市售的0.05%乳膏相比，对中度至重度银屑病印度患者的HPA轴抑制、疗效和安全性。
在这项2a期研究者设盲研究中，年龄≥18岁的中度至重度银屑病患者按1:1:1随机分组，分别接受0.025%制剂5或13的丙酸氯倍他索，或0.05%乳膏；每日两次，共28天。安全性终点包括第28天的促肾上腺皮质激素（ACTH）测试结果（主要终点），以及每次就诊时的局部耐受性（烧灼感/刺痛感/瘙痒，次要终点）。疗效终点包括银屑病整体评估（PGA）评分。
总体而言，88例患者接受了0.025%制剂5和13的丙酸氯倍他索（各29例）以及0.05%乳膏（30例）。在第28天，0.025%制剂组中促肾上腺皮质激素刺激试验异常（皮质醇水平≤18µg/dl）的患者比例在数值上低于0.05%乳膏组：制剂5为20.7%，制剂13为17.2%，而0.05%乳膏组为30.0%，（p = 0.320）。所有治疗组中烧灼感/刺痛感/瘙痒评分的降低情况相当，0.025%制剂组的PGA成功率更高：制剂5为38.9%，制剂13为36.8%，而0.05%乳膏组为30.8%。
与0.05%乳膏相比，0.025%的丙酸氯倍他索可能是治疗中度至重度银屑病的有效方法，显示出相当的疗效且全身安全性更好。
REF/2018/01/016779。
