Capriotti Kara, Stewart Kevin P, Pelletier Jesse S, Capriotti Joseph
ALC Therapeutics, LLC, Springhouse, PA, USA.
Bryn Mawr Skin and Cancer Institute, Rosemont, PA, USA.
Dermatol Ther (Heidelb). 2015 Dec;5(4):247-252. doi: 10.1007/s13555-015-0086-1. Epub 2015 Nov 3.
Verruca vulgaris, also known as common warts, are benign skin growths caused by infection of the skin by human papillomavirus. Warts are common in both childhood and adulthood and are spread by direct contact or autoinoculation. Treatment options vary from locally destructive methods to immuno-modulatory therapy. Common warts are often resistant to treatment. Though many remedies exist, there is no consensus therapy backed by randomized-controlled clinical trials that are FDA approved for the treatment of verruca vulgaris. We describe here the results of a small, randomized, double-blind, vehicle-controlled Phase II clinical trial with a novel topical agent for the treatment of common warts.
Twenty-one patients aged 8 years and older were enrolled in this single-center, randomized, double-blind, vehicle-controlled Phase II clinical trial to assess the efficacy, safety and tolerability of twice-daily application of a novel 2% topical povidone-iodine solution in a dimethyl sulfoxide vehicle for 12 weeks duration. Patients were block randomized into two groups consisting of 14 patients in the active arm and 7 patients in the vehicle only arm. All patients were evaluated at baseline, week 4, 8 and 12 and the results compared for overall Global Aesthetic Improvement Scale (GAIS) improvement.
There were a total of 21 patients included in the study. Sustained improvement in the GAIS scale was observed at the final week 12 exam visit in 77% of subjects in the treatment arm and 33% of patients in the control arm. There were no serious safety or tolerability issues reported.
Twice-daily topical povidone-iodine solution in the novel vehicle employed for this study is an effective, safe and easy-to-use treatment for common warts. Further study of this agent in expanded Phase II and Phase III clinical trials is warranted.
ALC Therapeutics LLC.
寻常疣，也称为普通疣，是由人乳头瘤病毒感染皮肤引起的良性皮肤增生。疣在儿童期和成年期都很常见，可通过直接接触或自体接种传播。治疗方法从局部破坏方法到免疫调节疗法不等。普通疣通常对治疗有抗性。虽然有许多治疗方法，但尚无经美国食品药品监督管理局批准用于治疗寻常疣的随机对照临床试验支持的共识疗法。我们在此描述一项小型、随机、双盲、赋形剂对照的II期临床试验结果，该试验使用一种新型外用剂治疗普通疣。
21名8岁及以上的患者参加了这项单中心、随机、双盲、赋形剂对照的II期临床试验，以评估一种新型2%外用聚维酮碘溶液（以二甲亚砜为赋形剂）每日两次应用12周的疗效、安全性和耐受性。患者被区组随机分为两组，治疗组14例，仅使用赋形剂组7例。所有患者在基线、第4周、第8周和第12周进行评估，并比较总体全球美学改善量表（GAIS）改善情况的结果。
该研究共纳入21名患者。在第12周的最终检查访视时，治疗组77%的受试者和对照组33%的患者的GAIS量表有持续改善。未报告严重的安全或耐受性问题。
本研究中使用的新型赋形剂中的外用聚维酮碘溶液每日两次是一种有效、安全且易于使用的普通疣治疗方法。有必要在扩大的II期和III期临床试验中对该药物进行进一步研究。
ALC Therapeutics LLC。
