Haiyan Zhang1, Lei Shi1, Yunfeng Zhang1, Peiru Wang1, Guolong Zhang1, Yajing Cao1, Zhongxia Zhou1, Xiuli Wang2. 1. Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China. 2. Institute of Photomedicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China. Electronic address: wangxiuli_1400023@tongji.edu.cn.
Abstract
BACKGROUND: Pain is a major concern associated with conventional photodynamic therapy (C-PDT). OBJECTIVE: To evaluate the efficacy, pain and safety of modified photodynamic therapy(M-PDT) for the treatment of condylomata acuminata. METHODS: A prospective, randomized, self-controlled study was conducted. Warts were randomized to the M-PDT or C-PDT side. 5-aminolevulinic acid (ALA; 20 %) was incubated for 3 h before patients were exposed to LED red light (100 J/cm2) on the C-PDT side and for 30 min before being exposed to LED red light (300 J/cm2) on the M-PDT side. Treatment was administered with 1-week interval for three weeks. The clearance rates were determined at one week and the recurrence rates at 4, 8, and 12 weeks after treatment. The pain and other side effects were also investigated. RESULTS: A total of 24 patients with condylomata acuminata were enrolled in this trial. Twenty patients completed the trial. The clearance rates were 98.17 % in the M-PDT side and 98.20 % in the C-PDT side(P > 0.05). The recurrence rates were 11.11 % and 10.53 % (P > 0.05). However, M-PDT was almost painless (mean score 0.3 ± 0.47, range 0∼1), which was significantly less than that on the C-PDT side (mean score 3.6 ± 0.94, range 0∼1) (P < 0.05). Local erythema, mild edema and erosion were observed on both sides. CONCLUSION: The modified PDT is basically painless with similar efficacy to conventional PDT, which is a major breakthrough of pain management in PDT.
RCT Entities:
BACKGROUND:Pain is a major concern associated with conventional photodynamic therapy (C-PDT). OBJECTIVE: To evaluate the efficacy, pain and safety of modified photodynamic therapy(M-PDT) for the treatment of condylomata acuminata. METHODS: A prospective, randomized, self-controlled study was conducted. Warts were randomized to the M-PDT or C-PDT side. 5-aminolevulinic acid (ALA; 20 %) was incubated for 3 h before patients were exposed to LED red light (100 J/cm2) on the C-PDT side and for 30 min before being exposed to LED red light (300 J/cm2) on the M-PDT side. Treatment was administered with 1-week interval for three weeks. The clearance rates were determined at one week and the recurrence rates at 4, 8, and 12 weeks after treatment. The pain and other side effects were also investigated. RESULTS: A total of 24 patients with condylomata acuminata were enrolled in this trial. Twenty patients completed the trial. The clearance rates were 98.17 % in the M-PDT side and 98.20 % in the C-PDT side(P > 0.05). The recurrence rates were 11.11 % and 10.53 % (P > 0.05). However, M-PDT was almost painless (mean score 0.3 ± 0.47, range 0∼1), which was significantly less than that on the C-PDT side (mean score 3.6 ± 0.94, range 0∼1) (P < 0.05). Local erythema, mild edema and erosion were observed on both sides. CONCLUSION: The modified PDT is basically painless with similar efficacy to conventional PDT, which is a major breakthrough of pain management in PDT.