A dose-finding study for hemoporfin in photodynamic therapy for port-wine stain: a multicenter randomized double-blind phase IIb trial

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

PDT with 5 mg hemoporfin could be an effective and safe treatment for PWS.

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