Siegel Daniel M, Tyring Stephen, Nahm Walter K, Østerdal Marie Louise, Petersen Astrid H, Berman Brian
Dr. Siegel is with Long Island Skin Cancer and Dermatologic Surgery in New York, New York.
Dr. Tyring is with the Center for Clinical Studies in Houston, Texas.
J Clin Aesthet Dermatol. 2017 Dec;10(12):19-26. Epub 2017 Dec 1.
The purpose of this study was to evaluate the safety and efficacy of ingenol disoxate gel using a once-daily, three-day field treatment regimen in patients with actinic keratosis. This was a Phase II, multicenter, open-label trial (clinicaltrials.gov: NCT02305888). The study was conducted in 20 trial sites in the United States. Participants included patients with 5 to 20 clinically typical actinic keratosis lesions on the full face/chest (250cm), scalp (25-250cm), or the trunk/extremities (250cm). We measured incidence of dose-limiting events based on local skin responses. Percentage reduction in actinic keratosis lesion count from baseline, complete clearance, and partial clearance (≥75%) of actinic keratosis lesions were assessed at Week 8. Nine of 63 (14.3%) patients in the face/chest group reported dose-limiting events; zero of 63 patients in the scalp group reported dose-limiting events; and 11 of 62 (17.7%) patients in the trunk/extremities group reported dose-limiting events. Mean composite local skin response scores peaked at Day 4, then rapidly declined, reaching or approaching baseline levels by Week 4. Less than five percent of patients reported severe adverse events; the most common treatment-related adverse events were application site pain and pruritus. The reduction in actinic keratosis lesion count was 78.9, 76.3, and 69.1 percent for the face/chest, scalp, and trunk/extremities groups, respectively. Complete clearance was achieved in 36.5, 39.7, and 22.6 percent of patients in the face/chest, scalp, and trunk/extremities groups, respectively. Partial clearance was achieved in 71.4, 65.1, and 50.0 percent of patients in the face/chest, scalp, and trunk/extremities groups, respectively. Ingenol disoxate demonstrated adverse events and local skin reaction profiles similar to results seen in trials evaluating shorter two-day regimens and was effective in patients with actinic keratosis. These data support the use of ingenol disoxate gel for actinic keratosis field treatment.
本研究的目的是评估每日一次、为期三天的局部治疗方案使用鬼臼二乙磺酸盐凝胶治疗光化性角化病患者的安全性和有效性。这是一项II期、多中心、开放标签试验（clinicaltrials.gov：NCT02305888）。该研究在美国的20个试验地点进行。参与者包括全脸/胸部（250平方厘米）、头皮（25 - 250平方厘米）或躯干/四肢（250平方厘米）有5至20个临床典型光化性角化病皮损的患者。我们根据局部皮肤反应测量剂量限制事件的发生率。在第8周评估光化性角化病皮损计数相对于基线的减少百分比、完全清除率和部分清除率（≥75%）。面部/胸部组63名患者中有9名（14.3%）报告了剂量限制事件；头皮组63名患者中0名报告了剂量限制事件；躯干/四肢组62名患者中有11名（17.7%）报告了剂量限制事件。平均综合局部皮肤反应评分在第4天达到峰值，然后迅速下降，到第4周时达到或接近基线水平。不到5%的患者报告了严重不良事件；最常见的与治疗相关的不良事件是用药部位疼痛和瘙痒。面部/胸部、头皮和躯干/四肢组光化性角化病皮损计数的减少分别为78.9%、76.3%和69.1%。面部/胸部、头皮和躯干/四肢组分别有36.5%、39.7%和22.6%的患者实现了完全清除。面部/胸部、头皮和躯干/四肢组分别有71.4%、65.1%和50.0%的患者实现了部分清除。鬼臼二乙磺酸盐的不良事件和局部皮肤反应情况与评估较短的两天治疗方案的试验结果相似，且对光化性角化病患者有效。这些数据支持使用鬼臼二乙磺酸盐凝胶进行光化性角化病的局部治疗。
