Eichenfield Lawrence F, Kwong Pearl, Gonzalez Mercedes E, Yan Albert, D'Arnaud Pieter, Burnett Patrick, Olivadoti Melissa
Dr. Eichenfield is with Rady Children's Hospital and the University of California, San Diego, Medical School in San Diego, California.
Dr. Kwong is with Solutions Through Advanced Research in Jacksonville, Florida.
J Clin Aesthet Dermatol. 2021 Oct;14(10):42-47.
ClinicalTrials.gov identifier nos. NCT03377790 (for CAMP-1) and NCT03377803 (for CAMP-2).
VP-102 is drug-device combination product containing cantharidin (0.7% w/v) and has undergone Phase III clinical trials for the treatment of molluscum contagiosum (molluscum). Efficacy and safety may differ by body region due to variable skin anatomy.
We investigated the pooled safety and efficacy of VP-102 by affected body region.
Individuals at least two years of age with molluscum were randomized to topical VP-102 or vehicle once every 21 days until clear (maximum of four applications). Participants were assigned to body region groups where lesions were present at baseline. Body region lesion counts were recorded at each visit. Efficacy was measured by the percentage of participants with complete clearance of lesions by region. Pre-specified adverse events (AEs) were analyzed for those treated in the region on that visit.
Participants had a mean of two regions affected at baseline. Complete clearance was significantly higher in the VP-102-treated group than with vehicle application in all regions at the last visit (<0.01 for each region). The incidence of pre-specified AEs was consistent across regions. However, these analyses were and individual lesions were not tracked for efficacy.
VP-102 treatment shows consistent safety and efficacy across molluscum body regions.
ClinicalTrials.gov标识符编号：NCT03377790（用于CAMP - 1）和NCT03377803（用于CAMP - 2）。
VP - 102是一种含有斑蝥素（0.7% w/v）的药物 - 器械组合产品，已进行治疗传染性软疣（软疣）的III期临床试验。由于皮肤解剖结构的差异，疗效和安全性可能因身体部位而异。
我们按受影响的身体部位调查了VP - 102的综合安全性和疗效。
患有软疣的至少两岁个体被随机分为每21天接受一次外用VP - 102或赋形剂治疗，直至疣体清除（最多4次用药）。参与者被分配到基线时有皮损的身体部位组。每次访视时记录身体部位的皮损计数。疗效通过各部位皮损完全清除的参与者百分比来衡量。对该次访视中该部位治疗的参与者分析预先指定的不良事件（AE）。
参与者在基线时平均有两个身体部位受影响。在最后一次访视时，VP - 102治疗组在所有部位的完全清除率均显著高于赋形剂治疗组（每个部位P<0.01）。预先指定的AE发生率在各部位一致。然而，这些分析是 且未跟踪个体皮损的疗效。
VP - 102治疗在传染性软疣的各个身体部位显示出一致的安全性和疗效。
