Laser and Skin Surgery Center of Indiana, Carmel, Indiana.
Enverus Medical, Surrey, British Columbia, Canada.
J Am Acad Dermatol. 2020 Mar;82(3):642-650. doi: 10.1016/j.jaad.2019.07.083. Epub 2019 Jul 30.
Ingenol mebutate (IngMeb) 0.015% or 0.05% is approved for actinic keratosis (AK) areas of 25 cm or less; some patients require treatment of larger fields.
To determine efficacy and safety of IngMeb 0.027% in areas of AK of up to 250 cm during an 8-week initial assessment period and extended 12-month follow-up.
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) or chest (approximately 250 cm). Patients received once-daily IngMeb or vehicle for 3 consecutive days on the full face, full balding scalp, or approximately 250 cm 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.
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.
Localized skin responses hindered maintenance of double-blinding.
IngMeb 0.027% was superior to vehicle for treatment of AK areas of up to 250 cm. The safety profile of IngMeb was as expected.
英格莫特（IngMeb）0.015%或 0.05%已获准用于治疗面积不超过 25cm 的光化性角化病（AK）；部分患者需要治疗更大面积的病变。
评估 IngMeb 0.027%在 8 周初始评估期和 12 个月延长随访期间治疗面积不超过 250cm 的 AK 的疗效和安全性。
这是一项 3 期、随机、双盲、安慰剂对照试验（NCT02361216），纳入了面部/头皮（25-250cm）或胸部（约 250cm）有 5-20 处 AK 病变的成年患者。患者接受连续 3 天每天 1 次 IngMeb 或安慰剂治疗，在整个面部、整个脱发头皮或胸部约 250cm 面积上使用。主要终点为第 8 周完全 AK 清除（AKCLEAR 100）。次要终点包括部分 AK 清除（AKCLEAR 75）、复发、患者满意度、美容效果和安全性。
第 8 周时，IngMeb 组完全 AK 清除（21.4%比 3.4%，P<0.001）和 AK 清除率达 75%或更高（59.4%比 8.9%，P<0.001）的比例均显著优于安慰剂组。在 12 个月随访期间，IngMeb 组患者持续清除率为 22.9%。与安慰剂相比，IngMeb 可显著提高患者的治疗满意度和美容效果。未发现新的安全性信号。
局部皮肤反应妨碍了双盲的维持。
与安慰剂相比，IngMeb 0.027%治疗面积不超过 250cm 的 AK 更有效。IngMeb 的安全性与预期一致。
