Berg Jeffrey E, Bowman James P, Saenz Alessandra B Alió
Hill Top Research, St. Petersburg, Florida 33710, USA.
Cutis. 2012 Oct;90(4):206-11.
We performed 2 phase 1 patch studies to evaluate tazarotene foam 0.1% for cumulative irritation potential (study A) and contact sensitization potential (study B). Study A participants wore patches containing active study product, vehicle foam, and positive and negative controls for 24 +/- 1 hours for 21 consecutive days. Irritation scores were statistically higher with tazarotene foam 0.1% than vehicle foam and both controls. Fourteen participants (36%) experienced product-related, application-site adverse events (AEs); all of the AEs were mild and transient. Study B participants were exposed to active product and vehicle foam for an induction and challenge phase. At the investigators discretion, participants were administered a rechallenge to evaluate for contact sensitization. Three participants demonstrated questionable sensitization reactions and underwent a rechallenge; none of the participants displayed conclusive contact sensitization. Three application-site AEs were considered to be product related; none of the AEs led to study discontinuation. Tazarotene foam 0.1% showed potential to induce irritation but a low potential for contact sensitization and an acceptable tolerability and safety profile.
我们进行了两项1期贴剂研究，以评估0.1%的他扎罗汀泡沫制剂的累积刺激可能性（研究A）和接触致敏可能性（研究B）。研究A的参与者连续21天佩戴含有活性研究产品、赋形剂泡沫以及阳性和阴性对照的贴剂24±1小时。0.1%的他扎罗汀泡沫制剂的刺激评分在统计学上高于赋形剂泡沫和两种对照。14名参与者（36%）出现了与产品相关的、应用部位不良事件（AE）；所有不良事件均为轻度且短暂的。研究B的参与者在诱导期和激发期接触活性产品和赋形剂泡沫。根据研究者的判断，对参与者进行再激发以评估接触致敏情况。3名参与者表现出可疑的致敏反应并接受了再激发；没有参与者表现出明确的接触致敏。3例应用部位不良事件被认为与产品相关；没有不良事件导致研究中断。0.1%的他扎罗汀泡沫制剂显示出有诱导刺激的可能性，但接触致敏可能性较低，且耐受性和安全性良好。
