Hemoporfin Photodynamic Therapy for Port-Wine Stain: A Randomized Controlled Trial

Yi Zhao, Ping Tu, Guoyu Zhou, Zhanchao Zhou, Xiaoxi Lin, Huilan Yang, Zhong Lu, Tianwen Gao, Yating Tu, Hongfu Xie, Qingshan Zheng, Ying Gu, Jining Tao and Xuejun Zhu

PLOS ONE, 2016, vol. 11, issue 5, 1-19

Abstract: Background and Objectives: Photodynamic therapy (PDT) has shown potentially beneficial results in treating port-wine stain, but its benefit–risk profile remains undefined. This study aimed to evaluate the efficacy and safety of PDT conducted with hemoporfin and a 532 nm continuous wave laser to treat port-wine stain clinically. Patients and Methods: This randomized clinical trial was conducted in eight hospitals in China. Participants were adolescent and adult patients (age range: 14–65 years old) with port-wine stain. During stage 1 (day 1 to week 8) all patients were randomized at a 3:1 ratio to treatment (532 nm laser irradiation (96–120 J/cm2) with hemoporfin (5mg/kg; PDT-hemoporfin, n = 330)) or placebo groups (irradiation with placebo (PDT-placebo, n = 110)); during stage 2 (week 8 to 16) patients in both groups were offered treatment. Clinician-evaluators, who were blind to the study, classified each case on the following four-level scale according to assessment of before and after standardized pictures of the lesion area: no improvement:

Date: 2016
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Persistent link: https://EconPapers.repec.org/RePEc:plo:pone00:0156219

DOI: 10.1371/journal.pone.0156219

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