Tyring Stephen K, Rosen Theodore, Berman Brian, Stasko Nathan, Durham Todd, Maeda-Chubachi Tomoko
J Drugs Dermatol. 2018 Oct 1;17(10):1100-1105.
Nitric oxide (NO), a free radical gas, is endogenously produced in human cells. In high concentration, NO neutralizes many disease-causing microbes. The topical investigational drug SB206 releases NO and has the potential to treat skin diseases caused by viruses. Genital warts (condyloma acuminata) are primarily caused by human papillomavirus (HPV) types 6 and 11. Available treatments have low tolerability and efficacy rates and are inconvenient for the patient. Genital warts can recur if HPV is incompletely eradicated during treatment.
Topical SB206 (berdazimer sodium plus carboxymethyl cellulose hydrogel) was assessed for tolerability, safety, and efficacy for up to12 weeks in patients with external genital and/or perianal warts (EGW/PAW) in a phase 2, double-blind, randomized, dose-escalation study.
Patients (N=108) were randomly assigned to SB206 or vehicle in a 3:1 ratio: SB206 4% once (QD) or twice daily (BID), 8% QD, 12% QD, or corresponding vehicle. Treatment duration was up to 84 days. The primary efficacy endpoint was complete clearance of baseline EGW/PAW at or before week 12. Pearson's Chi Square tests compared the efficacy of active vs vehicle treatments. Safety was assessed through adverse event and tolerability reports, physical examination findings, and clinical laboratory test results.
In the Intent-to-Treat population, the percentage of patients with complete clearance of baseline EGW/PAW at or before week 12 was higher for SB206 groups than for vehicle groups, with the greatest difference between SB206 12% QD (33.3%; P=0.010) and vehicle QD (4.3%).
Berdazimer sodium (SB206) plus hydrogel was efficacious and well tolerated in the treatment of EGW/PAW. J Drugs Dermatol. 2018;17(10):1100-1105.
一氧化氮（NO）是一种自由基气体，在人体细胞内由内源性产生。高浓度时，NO可中和多种致病微生物。局部研究药物SB206可释放NO，具有治疗由病毒引起的皮肤病的潜力。尖锐湿疣主要由6型和11型人乳头瘤病毒（HPV）引起。现有治疗方法的耐受性和有效率较低，且对患者不方便。如果治疗期间HPV未被完全根除，尖锐湿疣可能会复发。
在一项2期双盲、随机、剂量递增研究中，对局部应用SB206（伯达齐默钠加羧甲基纤维素水凝胶）治疗外生殖器和/或肛周疣（EGW/PAW）患者长达12周的耐受性、安全性和有效性进行评估。
患者（N = 108）按3:1的比例随机分配至SB206组或赋形剂组：4% SB206每日一次（QD）或每日两次（BID）、8% SB206 QD、12% SB206 QD或相应赋形剂。治疗持续时间长达84天。主要疗效终点是在第12周或之前基线EGW/PAW完全清除。采用Pearson卡方检验比较活性药物与赋形剂治疗的疗效。通过不良事件和耐受性报告、体格检查结果及临床实验室检测结果评估安全性。
在意向性治疗人群中，SB206组在第12周或之前基线EGW/PAW完全清除的患者百分比高于赋形剂组，其中12% SB206 QD组（33.3%；P = 0.010）与赋形剂QD组（4.3%）之间差异最大。
伯达齐默钠（SB206）加水凝胶治疗EGW/PAW有效且耐受性良好。《药物皮肤病学杂志》。2018；17(10):1100 - 1105。
