RESEARCH ARTICLE
Hemoporfin Photodynamic Therapy for PortWine Stain: A Randomized Controlled Trial Yi Zhao1☯, Ping Tu1☯, Guoyu Zhou2☯, Zhanchao Zhou3, Xiaoxi Lin4, Huilan Yang5, Zhong Lu6, Tianwen Gao7, Yating Tu8, Hongfu Xie9, Qingshan Zheng10, Ying Gu11, Jining Tao12*, Xuejun Zhu1*
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OPEN ACCESS Citation: Zhao Y, Tu P, Zhou G, Zhou Z, Lin X, Yang H, et al. (2016) Hemoporfin Photodynamic Therapy for Port-Wine Stain: A Randomized Controlled Trial. PLoS ONE 11(5): e0156219. doi:10.1371/journal. pone.0156219
1 Department of Dermatology and Venereology, Peking University First Hospital, Beijing, China, 2 Department of Oral Maxillofacial Surgery, Ninth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine. Shanghai, China, 3 Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College, Nanjing, China, 4 Department of Plastic and Reconstructive Surgery, Ninth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine. Shanghai, China, 5 Department of Dermatology, The General Hospital of Guangzhou Military Command, Guangzhou, China, 6 Department of Dermatology, Huashan Hospital, Fudan University, Shanghai, China, 7 Institute of Dermatology of Chinese PLA, Xijing Hospital, Fourth Military Medical University, Xi’an, China, 8 Department of Dermatology, Union Hospital of Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China, 9 Department of Dermatology, Xiangya Hospital Central South University, Changsha, China, 10 Center for Drug Clinical Research, Shanghai University of Chinese Traditional Medicine, Shanghai, China, 11 Department of Laser Medicine, Chinese PLA General Hospital, Beijing, China, 12 Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd., Shanghai, China ☯ These authors contributed equally to this work. * [email protected] (JT); [email protected] (XZ)
Abstract
Editor: Parasuraman Padmanabhan, The Lee Kong Chian School of Medicine, SINGAPORE Received: October 27, 2015
Background and Objectives
Accepted: May 11, 2016
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.
Published: May 26, 2016 Copyright: © 2016 Zhao et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Data Availability Statement: All relevant data are within the paper and its Supporting Information files. Funding: This study was co-sponsored by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. and the Chinese PLA General Hospital, and was funded by the former. The sponsors had no role in the collection, management, or analysis of the data, or interpretation of the data, preparation of the manuscript, or decision to submit the manuscript for publication. In collaboration with the academic coauthors, both cosponsors were involved in the design of the study. The funder was involved in the conduct of the study and reviewed the manuscript
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:
Hemoporfin Photodynamic Therapy for PortWine Stain: A Randomized Controlled Trial Yi Zhao1☯, Ping Tu1☯, Guoyu Zhou2☯, Zhanchao Zhou3, Xiaoxi Lin4, Huilan Yang5, Zhong Lu6, Tianwen Gao7, Yating Tu8, Hongfu Xie9, Qingshan Zheng10, Ying Gu11, Jining Tao12*, Xuejun Zhu1*
a11111
OPEN ACCESS Citation: Zhao Y, Tu P, Zhou G, Zhou Z, Lin X, Yang H, et al. (2016) Hemoporfin Photodynamic Therapy for Port-Wine Stain: A Randomized Controlled Trial. PLoS ONE 11(5): e0156219. doi:10.1371/journal. pone.0156219
1 Department of Dermatology and Venereology, Peking University First Hospital, Beijing, China, 2 Department of Oral Maxillofacial Surgery, Ninth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine. Shanghai, China, 3 Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College, Nanjing, China, 4 Department of Plastic and Reconstructive Surgery, Ninth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine. Shanghai, China, 5 Department of Dermatology, The General Hospital of Guangzhou Military Command, Guangzhou, China, 6 Department of Dermatology, Huashan Hospital, Fudan University, Shanghai, China, 7 Institute of Dermatology of Chinese PLA, Xijing Hospital, Fourth Military Medical University, Xi’an, China, 8 Department of Dermatology, Union Hospital of Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China, 9 Department of Dermatology, Xiangya Hospital Central South University, Changsha, China, 10 Center for Drug Clinical Research, Shanghai University of Chinese Traditional Medicine, Shanghai, China, 11 Department of Laser Medicine, Chinese PLA General Hospital, Beijing, China, 12 Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd., Shanghai, China ☯ These authors contributed equally to this work. * [email protected] (JT); [email protected] (XZ)
Abstract
Editor: Parasuraman Padmanabhan, The Lee Kong Chian School of Medicine, SINGAPORE Received: October 27, 2015
Background and Objectives
Accepted: May 11, 2016
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.
Published: May 26, 2016 Copyright: © 2016 Zhao et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Data Availability Statement: All relevant data are within the paper and its Supporting Information files. Funding: This study was co-sponsored by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. and the Chinese PLA General Hospital, and was funded by the former. The sponsors had no role in the collection, management, or analysis of the data, or interpretation of the data, preparation of the manuscript, or decision to submit the manuscript for publication. In collaboration with the academic coauthors, both cosponsors were involved in the design of the study. The funder was involved in the conduct of the study and reviewed the manuscript
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:
