Efficacy and safety of ingenol mebutate gel in field treatment of actinic keratosis on full face, balding scalp, or approximately 250 cm2 on the chest: A phase 3 randomized controlled trial
Efficacy and safety of ingenol mebutate gel in field treatment of actinic keratosis on full face, balding scalp, or approximately 250 cm2 on the chest: A phase 3 randomized controlled trial
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DOI：
10.1016/j.jaad.2019.07.083
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发表时间：
2020-03-01
影响因子：
13.8
通讯作者：
Spelman, Lynda
中科院分区：
文献类型：
--
作者：
Hanke, C. William;Albrecht, Lorne;Spelman, Lynda
背景资料：Ingenol mebutate（IngMeb）0.015%或0.05%被批准用于25 cm（2）或更小的光化性角化病（AK）区域;一些患者需要治疗更大的视野。目的：在8周的初始评估期和12个月的延长随访期间，确定Ingenol meb0.027%在250 cm（2）以下AK区域的有效性和安全性。这项III期、随机、双盲、溶剂对照试验（NCT 02361216）入组了面部/头皮（25-250 cm（2））或胸部（约250 cm（2））有5 - 20处AK病变的成人患者。患者接受每日一次IngMeb或车辆连续3天的全脸，全秃头皮，或约250厘米（2）的胸部。主要终点是AK完全清除（AKCLEAR 100;第8周）。结果：在第8周，IngMeb的AK完全清除率（21.4%vs 3.4%，P <0.001）和AK清除率为75%或更高（59.4%vs 8.9%，P <0.001）优于溶媒（上级）。在12个月随访期间，接受IngMeb治疗的患者持续清除的概率为22.9%。与溶媒相比，观察到IngMeb治疗满意度和美容结局增加。局限性：局部皮肤反应阻碍了双盲的维持。结论：0.027%的IngMeb在治疗高达250 cm（2）的AK区域方面优于溶剂，具有上级效果。IngMeb的安全性符合预期。
Background: Ingenol mebutate (IngMeb) 0.015% or 0.05% is approved for actinic keratosis (AK) areas of 25 cm(2) or less; some patients require treatment of larger fields.Objective: To determine efficacy and safety of IngMeb 0.027% in areas of AK of up to 250 cm(2) during an 8-week initial assessment period and extended 12-month follow-up.Methods: This phase 3, randomized, double-blind, vehicle-controlled trial (NCT02361216) enrolled adult patients with 5 to 20 AK lesions on the face/scalp (25-250 cm(2)) or chest (approximately 250 cm(2)). Patients received once-daily IngMeb or vehicle for 3 consecutive days on the full face, full balding scalp, or approximately 250 cm(2) on the chest. The primary endpoint was complete AK clearance (AKCLEAR 100; week 8). Additional endpoints included partial AK clearance (AKCLEAR 75), recurrence, patient satisfaction, cosmetic outcome, and safety.Results: IngMeb was superior to vehicle for complete AK clearance (21.4% vs 3.4%, P < .001) and AK clearance of 75% or greater (59.4% vs 8.9%, P < .001) at week 8. Probability of sustained clearance during the 12-month follow-up was 22.9% for patients treated with IngMeb. Increased treatment satisfaction and cosmetic outcomes were observed with IngMeb versus vehicle. No unexpected safety signals were identified.Limitations: Localized skin responses hindered maintenance of double-blinding.Conclusions: IngMeb 0.027% was superior to vehicle for treatment of AK areas of up to 250 cm(2). The safety profile of IngMeb was as expected.