title: Efficacy and safety of hemoporfin in photodynamic therapy for port-wine stain: a multicenter and open-labeled phase IIa study.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  Hemoporfin-PDT is effective and safe for patients with PWS aged 16-50.
authors.affiliation: Department of Dermatology and Venereology, Peking University First Hospital, Beijing, China.
authors.forename: Yi
authors.initials: Y
authors.lastname: Zhao
authors.forename: Zhanchao
authors.initials: Z
authors.lastname: Zhou
authors.forename: Guoyu
authors.initials: G
authors.lastname: Zhou
authors.forename: Ping
authors.initials: P
authors.lastname: Tu
authors.forename: Qingshan
authors.initials: Q
authors.lastname: Zheng
authors.forename: Jining
authors.initials: J
authors.lastname: Tao
authors.forename: Ying
authors.initials: Y
authors.lastname: Gu
authors.forename: Xuejun
authors.initials: X
authors.lastname: Zhu
mesh_terms: D000293:Adolescent; D000328:Adult; D006414:Hematoporphyrin Photoradiation / Q000009:adverse effects* / Q000379:methods; D006415:Hematoporphyrins / Q000627:therapeutic use*; D006801:Humans; D028022:Low-Level Light Therapy / Q000009:adverse effects* / Q000379:methods; D008875:Middle Aged; D017319:Photosensitizing Agents / Q000627:therapeutic use*; D019339:Port-Wine Stain / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D006415:Hematoporphyrins; D017319:Photosensitizing Agents; C494379:hematoporphyrin monomethyl ether