Efficacy and safety of hemoporfin in photodynamic therapy for port-wine stain: a multicenter and open-labeled phase IIa study

Authors


  • Conflicts of interest:
    All authors take responsibility for the accuracy and completeness of the data reported. The corresponding author has the final responsibility for the decision to submit the manuscript for publication. Jining Tao was the project supervisor of Shanghai Fudan-zhangjiang Bio-Pharmaceutical Co Ltd. The other authors declare that they have no conflict of interest.

Correspondence:
Xuejun Zhu, Department of Dermatology and Venereology, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing 100034, China.
Tel:/Fax: +86 10 6655 1216
e-mail: zhuxj@public.bta.net.cn

Abstract

Background/purpose: This phase IIa study aimed to study the efficacy and safety of hemoporfin in photodynamic therapy (PDT) with a 532 nm continuous laser for port-wine stain (PWS).

Methods: In this 8-week open-labeled study in three centers, three different laser exposure times (532 nm continuous laser for 20, 30 and 40 min) were used in stage I, group A, stage II, group B and stage III, group C, respectively. Primary efficacy assessment was performed by an independent group of experts, who reviewed the standardized photos. Secondary efficacy assessment consisted of the subjective grading of the PWS fading by the investigators and the patients. Treatment reactions and adverse events (AE) were recorded separately.

Results: Forty patients were initially enrolled in the study, but stage III had to be cancelled eventually for the safety of the patients. Patients in groups A and B showed similar satisfactory results in efficacy assessments, the total ‘response’ rate being 80.0% and 94.7% in groups A and B, respectively. The AE rates were also similar in the two groups. Self-limiting photosensitive dermatitis and hyperpigmentation were the most frequently observed AE.

Conclusion: Hemoporfin-PDT is effective and safe for patients with PWS aged 16–50.

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