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

Author

Listed:
  • 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
  • Xuejun Zhu

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:

Suggested Citation

  • 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 & Xuejun Zhu, 2016. "Hemoporfin Photodynamic Therapy for Port-Wine Stain: A Randomized Controlled Trial," PLOS ONE, Public Library of Science, vol. 11(5), pages 1-19, May.
    • Handle: RePEc:plo:pone00:0156219
    DOI: 10.1371/journal.pone.0156219
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