Center for Clinical and Cosmetic Research, Aventura, FL.
Dermatol Online J. 2020 Oct 15;26(10):13030/qt7677c8r4.
Actinic keratosis (AK) is a skin condition arising from chronic exposure to ultraviolet light and may lead to the development of malignancies. This trial aimed to evaluate efficacy and safety of ingenol disoxate gel (IngDsx, 0.018% for face/chest [FC]; 0.037% for scalp [S]), versus vehicle.
Four identical phase 3 trials in patients with AK on the full face/up to 250cm2 of chest or full balding scalp, with an initial 8-week period and 12-month follow-up, were conducted. FC and S trials were pooled for analysis. The primary endpoint was complete clearance at Week 8.
Across trials, 616 patients were randomized to FC and 626 to S, with 410 and 420 assigned to receive IngDsx, respectively. In the FC and S trials, 25.9% and 24.5% of patients in the IngDsx group, respectively, achieved the primary endpoint. IngDsx was relatively well tolerated. During extended follow-up, there were more identified non-melanoma skin malignancies in the IngDsx group than vehicle group; HR: 2.38 (95% CI: 1.28, 4.41).
Treatment with IngDsx was superior to vehicle on all clinical endpoints, patient-reported and cosmetic outcomes. During the 12-month follow-up, slightly increased skin malignancies in the treatment area were identified, potentially due to unintentional detection bias.
光化性角化病（AK）是一种由慢性暴露于紫外线下引起的皮肤状况，可能导致恶性肿瘤的发展。本试验旨在评估 ingenol 双氧化物凝胶（IngD，0.018%用于面部/胸部[FC]；0.037%用于头皮[S]）与赋形剂相比的疗效和安全性。
在患有 AK 的患者中进行了四项完全相同的 3 期试验，这些患者的全脸/最多 250cm2 的胸部或全秃头皮，初始 8 周和 12 个月随访，对 FC 和 S 试验进行了汇总分析。主要终点是第 8 周时完全清除。
在所有试验中，616 名患者被随机分配到 FC 组和 626 名患者到 S 组，分别有 410 名和 420 名患者接受了 IngD 治疗。在 FC 和 S 试验中，IngD 组分别有 25.9%和 24.5%的患者达到了主要终点。IngD 相对耐受良好。在延长随访期间，IngD 组发生的非黑素瘤皮肤恶性肿瘤比赋形剂组更多；HR：2.38（95%CI：1.28，4.41）。
与赋形剂相比，IngD 在所有临床终点、患者报告和美容结果方面均具有优越性。在 12 个月的随访期间，在治疗区域发现了皮肤恶性肿瘤略有增加，这可能是由于非故意的检测偏差。
