Sidgiddi Srinivas, Pakunlu Refika I, Allenby Kent
Drs Sidgiddi, Pakunlu, and Allenby are with Promius Pharma, a subsidiary of Dr. Reddy's Laboratories, in Princeton, New Jersey.
J Clin Aesthet Dermatol. 2018 Apr;11(4):14-22. Epub 2018 Apr 1.
A spray formulation of betamethasone dipropionate 0.05% (BD spray 0.05%; Sernivo™ [betamethasone dipropionate] Spray 0.05%; Promius Pharma, LLC; Princeton, New Jersey, USA) has been developed for the topical treatment of psoriasis. The objective of these studies was to evaluate the efficacy, safety, and potency of BD spray 0.05%. Efficacy and safety were assessed in a randomized, vehicle-controlled, double-blind study in adults with moderate plaque psoriasis (ClinicalTrials.gov identifier: NCT01947491). Additionally, the potential for adrenal suppression and systemic absorption was evaluated in a randomized, open-label study in healthy adults (ClinicalTrials.gov identifier: NCT02070965). Potency was measured in two single-point, randomized, evaluator-blinded studies in healthy adults. BD spray 0.05% was significantly more effective than the vehicle spray in subjects with moderate plaque psoriasis after three, 14, and 28 days of twice-daily treatment. The efficacy of BD spray 0.05% was similar to augmented BD lotion 0.05% after 14 days of treatment. The safety of BD spray 0.05% was similar to that of the vehicle spray over 28 days and to that of augmented BD lotion 0.05% over 14 days. Under maximal use conditions for up to 29 days, the potential for adrenal suppression was no greater with BD spray 0.05% than with a 15-day regimen of augmented BD lotion 0.05%. There was less systemic absorption of BD from BD spray 0.05% than from augmented BD lotion 0.05%. Studies classify BD spray 0.05% as a midpotent corticosteroid. BD spray 0.05%, a midpotent corticosteroid, is an effective and well-tolerated treatment for adults with mild to moderate plaque psoriasis.
已研发出一种0.05%丙酸倍他米松喷雾制剂（BD喷雾0.05%；Sernivo™[丙酸倍他米松]喷雾0.05%；美国新泽西州普林斯顿的Promius制药公司）用于银屑病的局部治疗。这些研究的目的是评估BD喷雾0.05%的疗效、安全性和效力。在一项针对中度斑块状银屑病成人患者的随机、赋形剂对照、双盲研究中评估了疗效和安全性（ClinicalTrials.gov标识符：NCT01947491）。此外，在一项针对健康成人的随机、开放标签研究中评估了肾上腺抑制和全身吸收的可能性（ClinicalTrials.gov标识符：NCT02070965）。在两项针对健康成人的单点、随机、评估者盲法研究中测量了效力。在每日两次治疗3天、14天和28天后，BD喷雾0.05%在中度斑块状银屑病患者中比赋形剂喷雾显著更有效。治疗14天后，BD喷雾0.05%的疗效与0.05%增强型BD洗剂相似。BD喷雾0.05%在28天内的安全性与赋形剂喷雾相似，在14天内与0.05%增强型BD洗剂相似。在长达29天的最大使用条件下，BD喷雾0.05%导致肾上腺抑制的可能性不高于0.05%增强型BD洗剂15天治疗方案。BD喷雾0.05%的全身吸收比0.05%增强型BD洗剂少。研究将BD喷雾0.05%归类为中效皮质类固醇。BD喷雾0.05%，一种中效皮质类固醇，是治疗轻度至中度斑块状银屑病成人患者的有效且耐受性良好的疗法。
