Abstract | BACKGROUND AND OBJECTIVES: PATIENTS AND METHODS: This randomized clinical trial was conducted in eight hospitals in China. Participants were adolescent and adult patients (age range: 14-65 years old) with port-wine stain. During stage 1 (day 1 to week 8) all patients were randomized at a 3:1 ratio to treatment (532 nm laser irradiation (96-120 J/cm2) with hemoporfin (5mg/kg; PDT- hemoporfin, n = 330)) or placebo groups (irradiation with placebo ( PDT-placebo, n = 110)); during stage 2 (week 8 to 16) patients in both groups were offered treatment. Clinician-evaluators, who were blind to the study, classified each case on the following four-level scale according to assessment of before and after standardized pictures of the lesion area: no improvement: <20%; some improvement: 20-59%; great improvement: 60-89%; or nearly completely resolved: ≥90%. The primary efficacy endpoint was proportion of patients achieving at least some improvement at week 8. The secondary efficacy endpoints were proportion of patients achieving nearly completely resolved or at least great improvement at week 8, proportion of patients achieving early completely resolved, at least great improvement, or at least some improvement at week 16, and the corresponding satisfaction of the investigators and the patients (designated as 'excellent', 'good', 'moderate', or 'ineffective') at weeks 8 and 16. RESULTS: Compared to the PDT-placebo group, the PDT- hemoporfin group showed a significantly higher proportion of patients that achieved at least some improvement (89.7% [n = 295; 95% CI, 85.9%-92.5%] vs. 24.5% [n = 27; 95% CI, 17.4%-33.3%]) at week 8 (P < 0.0001) and higher improvements for all secondary efficacy endpoints. Treatment reactions occurred in 99.5% (n = 731; 95% CI, 98.7%-99.8%) of the PDT- hemoporfin treatments (n = 735). Hyperpigmentation occurred in 22.9 per 100 patient-treatments (n = 168; 95% CI, 20.0-26.0) in the PDT- hemoporfin treated patients. CONCLUSIONS: TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR-TRC-08000213.
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Authors | Yi Zhao, Ping Tu, Guoyu Zhou, Zhanchao Zhou, Xiaoxi Lin, Huilan Yang, Zhong Lu, Tianwen Gao, Yating Tu, Hongfu Xie, Qingshan Zheng, Ying Gu, Jining Tao, Xuejun Zhu |
Journal | PloS one
(PLoS One)
Vol. 11
Issue 5
Pg. e0156219
( 2016)
ISSN: 1932-6203 [Electronic] United States |
PMID | 27227544
(Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial)
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Chemical References |
- Hematoporphyrins
- Photosensitizing Agents
- hematoporphyrin monomethyl ether
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Topics |
- Adolescent
- Adult
- Aged
- China
- Double-Blind Method
- Female
- Hematoporphyrins
(therapeutic use)
- Humans
- Low-Level Light Therapy
- Male
- Middle Aged
- Photochemotherapy
- Photosensitizing Agents
(therapeutic use)
- Port-Wine Stain
(drug therapy, pathology)
- Treatment Outcome
- Young Adult
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