Department of Dermatology, Universidade de São Paulo, Hospital das Clínicas, São Paulo, Brazil.
Department of Dermatology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.
Br J Dermatol. 2018 Oct;179(4):829-835. doi: 10.1111/bjd.16473. Epub 2018 May 15.
Topical photodynamic therapy (PDT) is an approved treatment for actinic keratosis (AK). To enhance the efficacy of PDT for AKs, physical and chemical pretreatments have been suggested.
To compare the efficacy and safety of the combination of topical calcipotriol (CAL) before methyl aminolaevulinate (MAL)-PDT for AKs of the scalp vs. conventional MAL-PDT in a randomized controlled clinical trial.
Twenty patients with multiple AKs on the scalp were randomized to receive conventional MAL-PDT with previous curettage on one side of the scalp and CAL-assisted MAL-PDT once a day for 15 days before illumination on the other side. After 3 months, patients were evaluated for clearance of AKs, side-effects and histopathology before and after the procedure. Protoporphyrin IX (PpIX) fluorescence was measured before and after illumination on both sides.
All 20 patients completed the study. Overall AK clearance rates were 92·1% and 82·0% for CAL-PDT and conventional PDT, respectively (P < 0·001). Grade 1 AKs showed similar response rates for both sides (P = 0·055). However, grade II AKs showed more improvement on the CAL-PDT side (90%) than on the MAL-PDT side (63%) (P < 0·001). Before illumination, PpIX fluorescence intensity was higher on the CAL-assisted side (P = 0·048). The treatment was more painful on the CAL-PDT side, although well tolerated. The mean visual analogue scale score was 5·4 ± 1·4 on the CAL-PDT side and 4·0 ± 0·69 on the conventional MAL-PDT side (P = 0·001). Side-effects such as erythema (P = 0·019), oedema (P = 0·002) and crusts (P < 0·001) were more pronounced on the CAL-assisted side. Histopathological analyses were obtained from five patients and both sides showed improved keratinocyte atypia following PDT, with slightly more improvement on the CAL-assisted side.
CAL-assisted PDT proved to be safe and more effective than conventional MAL-PDT for the treatment of AKs on the scalp. CAL pretreatment increased PpIX accumulation within the skin and may have enhanced the efficacy in this first human trial.
局部光动力疗法（PDT）是一种已被批准用于治疗光化性角化病（AK）的方法。为了提高 PDT 治疗 AK 的疗效，已经提出了物理和化学预处理。
在一项随机对照临床试验中，比较头皮 AK 患者接受局部钙泊三醇（CAL）预处理后与常规甲氨基乙酰丙酸（MAL）-PDT 联合治疗的疗效和安全性。
20 例头皮多发性 AK 患者随机分为两组，一组在头皮一侧接受常规 MAL-PDT 治疗，同时进行刮除术，另一组在头皮另一侧每天接受 CAL 辅助 MAL-PDT 治疗 15 天，然后进行光照。3 个月后，评估患者 AK 清除率、不良反应和治疗前后的组织病理学变化。在两侧光照前后测量原卟啉 IX（PpIX）荧光。
所有 20 例患者均完成了研究。CAL-PDT 和常规 PDT 的 AK 总清除率分别为 92.1%和 82.0%（P<0.001）。1 级 AK 两侧的反应率相似（P=0.055）。然而，2 级 AK 患者在 CAL-PDT 侧的改善程度（90%）明显高于 MAL-PDT 侧（63%）（P<0.001）。光照前，CAL 辅助侧的 PpIX 荧光强度更高（P=0.048）。CAL-PDT 侧的治疗疼痛程度更高，但患者耐受性良好。CAL-PDT 侧的平均视觉模拟量表评分（VAS）为 5.4±1.4，常规 MAL-PDT 侧为 4.0±0.69（P=0.001）。CAL 辅助侧的红斑（P=0.019）、水肿（P=0.002）和结痂（P<0.001）等不良反应更为明显。5 例患者获得了组织病理学分析，结果显示 PDT 后两组的角质形成细胞异型性均有所改善，CAL 辅助侧的改善程度略高。
CAL 辅助 PDT 治疗头皮 AK 安全有效，优于常规 MAL-PDT。CAL 预处理可增加皮肤内 PpIX 的蓄积，可能增强了本项首次人体试验的疗效。
