Siller Medical Pty Ltd, Brisbane, Queensland, Australia.
Australas J Dermatol. 2010 May;51(2):99-105. doi: 10.1111/j.1440-0960.2010.00626.x.
To evaluate the safety of two applications of PEP005 (ingenol mebutate) gel in superficial basal cell carcinoma. Efficacy was a secondary end-point.
Randomized, vehicle-controlled, phase IIa study conducted at eight private dermatology clinics in Australia. A total of 60 patients with histologically confirmed superficial basal cell carcinoma (lesion size, 4-15 mm) were randomized to treatment on days 1 and 2 (Arm A) or days 1 and 8 (Arm B) and, within each arm, to ingenol mebutate gel, 0.0025%, 0.01% or 0.05%, or vehicle gel. The main outcome measures were the incidence and severity of adverse events and local skin responses in Arms A and B; lesion clearance at day 85 was a secondary measure.
The incidence of adverse events was low. One patient treated with ingenol mebutate gel, 0.05% in Arm A experienced severe flaking/scaling/dryness extending beyond the application site. Non-severe, potentially treatment-related events included erythema extending beyond the application site, application-site pain and headache in two patients each. Six patients in Arm A had one or more severe local skin responses. Efficacy appeared to be dose-related and there was a trend towards higher clinical and histological lesion clearance rates in Arm A compared with Arm B. Histological clearance occurred in five of eight patients (63%) randomized to ingenol mebutate gel, 0.05% in Arm A.
Two applications of ingenol mebutate gel, 0.05%, are safe and have efficacy in patients with superficial basal cell carcinoma.
评估 PEP005（ ingenol 美泊利特）凝胶两次应用于浅表基底细胞癌的安全性。疗效为次要终点。
在澳大利亚的 8 家私人皮肤科诊所进行了一项随机、赋形剂对照、IIa 期研究。共 60 例组织学确诊的浅表基底细胞癌（病变大小为 4-15mm）患者随机分为第 1 天和第 2 天（A 组）或第 1 天和第 8 天（B 组）治疗，每组内再随机分为 ingenol 美泊利特凝胶 0.0025%、0.01%或 0.05%或赋形剂凝胶。主要观察指标为 A 组和 B 组不良事件和局部皮肤反应的发生率和严重程度；第 85 天的皮损清除率为次要指标。
不良事件发生率低。A 组中 1 例接受 ingenol 美泊利特凝胶 0.05%治疗的患者出现严重的脱屑/结痂/干燥，超出了应用部位。非严重、可能与治疗相关的事件包括红斑超出应用部位、应用部位疼痛和头痛，各有 2 例。A 组中有 6 例患者出现 1 次或多次严重局部皮肤反应。疗效似乎与剂量相关，A 组的临床和组织学皮损清除率均高于 B 组，有升高趋势。A 组中 8 例随机接受 ingenol 美泊利特凝胶 0.05%治疗的患者中，有 5 例（63%）达到组织学完全清除。
两次应用 ingenol 美泊利特凝胶 0.05%治疗浅表基底细胞癌安全有效。
