Qiuju Wu1, Ping Tu2, Guoyu Zhou3, Huilan Yang4, Zhanchao Zhou1, Yi Zhao2, Qingshan Zheng5, Ying Gu6, Jining Tao7, Xuejun Zhu2. 1. Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College, Nanjing, China. 2. Department of Dermatology and Venereology, Peking University First Hospital, Beijing, China. 3. Department of Oral Maxillofacial Surgery, Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China. 4. Department of Dermatology, The General Hospital of Guangzhou Military Command, Guangzhou, China. 5. Center for Drug Clinical Research, Shanghai University of Chinese Traditional Medicine, Shanghai, China. 6. Department of Laser Medicine, Chinese PLA General Hospital, Beijing, China. 7. Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co. Ltd, Shanghai, China.
Abstract
BACKGROUND/ PURPOSE: Previous studies have shown that hemoporfin-mediated photodynamic therapy (PDT) was a treatment for port-wine stain (PWS). Our current study aimed to identify optimal hemoporfin dose. METHODS: A prospective, multicenter, double-blind, randomized clinical trial was conducted. Patients were assigned into low- or high-dose hemoporfin (2.5 mg/kg and 5 mg/kg intravenously, respectively), or control (placebo) group, at a rate of 2:2:1. Treatment efficacy was evaluated at week 8. Then, patients in control group were randomly assigned into either high- or low-dose hemoporfin group. Treatment reactions and adverse events were analyzed at week 16. RESULTS: A total of 100 patients (40, 40, 20 in low-, high-dose hemoporfin, and control group, respectively) were enrolled. Compared to low dose (40%) and control group (15%), a higher proportion of patients in high-dose group (75%) had achieved skin lesion improvements. Treatment satisfactions were graded highest in high-dose group. Compared to low-dose group (14.3%), high-dose group (46.0%) had more frequent skin hyperpigmentation, which disappeared 3-6 months after treatment. Other treatment reactions and adverse events were comparable between two groups. CONCLUSIONS:Photodynamic therapy with 5 mg/kg hemoporfin could be an effective and safe treatment for PWS.
RCT Entities:
BACKGROUND/ PURPOSE: Previous studies have shown that hemoporfin-mediated photodynamic therapy (PDT) was a treatment for port-wine stain (PWS). Our current study aimed to identify optimal hemoporfin dose. METHODS: A prospective, multicenter, double-blind, randomized clinical trial was conducted. Patients were assigned into low- or high-dose hemoporfin (2.5 mg/kg and 5 mg/kg intravenously, respectively), or control (placebo) group, at a rate of 2:2:1. Treatment efficacy was evaluated at week 8. Then, patients in control group were randomly assigned into either high- or low-dose hemoporfin group. Treatment reactions and adverse events were analyzed at week 16. RESULTS: A total of 100 patients (40, 40, 20 in low-, high-dose hemoporfin, and control group, respectively) were enrolled. Compared to low dose (40%) and control group (15%), a higher proportion of patients in high-dose group (75%) had achieved skin lesion improvements. Treatment satisfactions were graded highest in high-dose group. Compared to low-dose group (14.3%), high-dose group (46.0%) had more frequent skin hyperpigmentation, which disappeared 3-6 months after treatment. Other treatment reactions and adverse events were comparable between two groups. CONCLUSIONS: Photodynamic therapy with 5 mg/kg hemoporfin could be an effective and safe treatment for PWS.
Authors: M Ingmar van Raath; Sandeep Chohan; Albert Wolkerstorfer; Chantal M A M van der Horst; Jacqueline Limpens; Xuan Huang; Baoyue Ding; Gert Storm; René R W J van der Hulst; Michal Heger Journal: PLoS One Date: 2020-07-02 Impact factor: 3.240
Authors: Sara Sabeti; Karen L Ball; Craig Burkhart; Lawrence Eichenfield; Esteban Fernandez Faith; Ilona J Frieden; Roy Geronemus; Deepti Gupta; Andrew C Krakowski; Moise L Levy; Denise Metry; J Stuart Nelson; Megha M Tollefson; Kristen M Kelly Journal: JAMA Dermatol Date: 2021-01-01 Impact factor: 10.282