Background/PurposePrevious 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. MethodsA prospective, multicenter, double-blind, randomized clinical trial was conducted. Patients were assigned into low- or high-dose hemoporfin (2.5mg/kg and 5mg/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. ResultsA 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 3-6months after treatment. Other treatment reactions and adverse events were comparable between two groups. ConclusionsPhotodynamic therapy with 5mg/kg hemoporfin could be an effective and safe treatment for PWS.
[1]Chinese Acad Med Sci, Inst Dermatol, Nanjing, Jiangsu, Peoples R China.
[2]Peking Union Med Coll, Nanjing, Jiangsu, Peoples R China.
[3]Peking Univ, Hosp 1, Dept Dermatol & Venereol, Beijing, Peoples R China.
[4]Shanghai Jiao Tong Univ, Sch Med, Dept Oral Maxillofacial Surg, Peoples Hosp 9, Shanghai, Peoples R China.
[5]Gen Hosp Guangzhou Mil Command, Dept Dermatol, Guangzhou, Guangdong, Peoples R China.
[6]Shanghai Univ Chinese Tradit Med, Ctr Drug Clin Res, Shanghai, Peoples R China.
[7]Chinese Peoples Liberat Army Gen Hosp, Dept Laser Med, Beijing, Peoples R China.
[8]Shanghai Fudan Zhangjiang Biopharmaceut Co Ltd, Shanghai, Peoples R China.
(8.0+极速模式)