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Crisaborole 2% ointment for the treatment of intertriginous, anogenital, and facial psoriasis: A double-blind, randomized, vehicle-controlled trial.
Journal of the American Academy of Dermatology ( IF 13.8 ) Pub Date : 2019-07-03 , DOI: 10.1016/j.jaad.2019.06.1288
Peter W Hashim 1 , Margot Chima 1 , Hee J Kim 1 , Jennifer Bares 1 , Christopher J Yao 1 , Giselle Singer 1 , Tinley Chen 1 , Jordan Genece 1 , Danielle Baum 1 , Grace W Kimmel 1 , John K Nia 1 , Matthew Gagliotti 1 , Mark G Lebwohl 1
Affiliation  

BACKGROUND Psoriasis of the intertriginous, anogenital, and facial regions remains a therapeutic challenge, with current algorithms lacking a topical agent that exhibits both high efficacy and minimal side effects. OBJECTIVE To assess the safety and efficacy of crisaborole 2% ointment-a nonsteroidal phosphodiesterase 4 inhibitor-in the treatment of intertriginous, anogenital, and facial psoriasis. METHODS A double-blind, randomized, vehicle-controlled trial was conducted in 21 participants. Participants were randomized 2:1 to receive 4 weeks of twice-daily treatment with either crisaborole 2% ointment (n = 14) or vehicle ointment (n = 7), followed by 4 weeks of open-label treatment with crisaborole 2% ointment. Disease severity was measured by using the Target Lesion Severity Scale (TLSS). RESULTS After 4 weeks, participants in the crisaborole group demonstrated 66% improvement compared with 9% in the vehicle group (P = .0011). Participants in the crisaborole group continued to experience improvement through the open-label phase, demonstrating 81% lesional improvement by week 8, with 71% of these participants achieving clinical clearance. There were no adverse events. LIMITATIONS The study was limited to a single tertiary care center and small sample size. CONCLUSION Treatment with crisaborole 2% ointment was well-tolerated and led to clinical improvement in participants with intertriginous, anogenital, or facial psoriasis.

中文翻译:

2%的Crisaborole软膏用于治疗三尖瓣,肛门生殖器和面部牛皮癣:一项双盲,随机,赋形剂对照试验。

背景技术牛皮癣的三头肌,肛门生殖器和面部区域仍然是一种治疗挑战,目前的算法缺乏表现出高功效和最小副作用的局部用药。目的评估2%克雷伯伯丁软膏(一种非甾体磷酸二酯酶4抑制剂)在三尖瓣,肛门生殖器和面部牛皮癣治疗中的安全性和有效性。方法在21名参与者中进行了一项双盲,随机,车辆对照试验。参与者被随机以2:1的比例接受2周每天两次的瑞卡波罗2%软膏(n = 14)或赋形剂软膏(n = 7)的治疗,为期4周,然后接受4周瑞卡波罗2%软膏的开放标签治疗。疾病严重程度通过使用目标病变严重程度量表(TLSS)进行测量。结果4周后,沙丁胺醇组的参与者表现出66%的改善,而赋形剂组则为9%(P = .0011)。crisaborole组的参与者在开放标签阶段持续改善,表明到第8周时病灶改善了81%,其中71%的参与者达到了临床清除率。没有不良事件。局限性该研究仅限于单个三级护理中心且样本量较小。结论2%的克雷莎伯乐软膏治疗耐受性良好,并导致三叉性,肛门生殖器或面部牛皮癣患者的临床改善。在第8周时,病灶改善了81%,其中71%的受试者达到了临床清除率。没有不良事件。局限性该研究仅限于单个三级护理中心且样本量较小。结论2%的克雷莎伯乐软膏治疗耐受性良好,并导致三尖瓣,肛门生殖器或面部牛皮癣患者的临床改善。在第8周时,病灶改善了81%,其中71%的受试者达到了临床清除率。没有不良事件。局限性该研究仅限于单个三级护理中心且样本量较小。结论2%的克雷莎伯乐软膏治疗耐受性良好,并导致三尖瓣,肛门生殖器或面部牛皮癣患者的临床改善。
更新日期:2020-01-11
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