This is a multi-center, randomized, double-blind, vehicle-controlled, and sequential group Phase 2 study. Eligible subjects aged 18 to 75 years old with PWB will receive Hemoporfin PDT or vehicle PDT in 8-week cycles at fixed drug dose (5 mg/kg) and different light fluence.
Subject must be 18 to 75 years of age inclusive, at the time of signing the informed consent.
Subject is Fitzpatrick skin type I-VI.
A male subject must agree to use contraception during the Treatment Period and for at least 6 months after the last dose of study treatment and refrain from donating sperm during this period.
The subject has a clinical diagnosis of PWB located i) on the extremities, trunk, caudal cervical and/or retroauricular area (Stage One); ii) on the face and/or neck (Stage Two).
Subject is pregnant, lactating, or is planning to become pregnant during the study.
Subject has plaque/nodular changes and severe hypertrophy within the target PWB area.
Subject has Sturge-Weber syndrome.
Subject has any skin pathology or condition that, in the Investigator's opinion, could interfere with the evaluation of the study drug or requires use of interfering topical, systemic, or surgical therapy.
Parallel
Hemopfin+Green Light
DrugAll qualified subjects randomized to Hemoporfin PDT treatment to receive up to 3 cycles of treatment.
Vehicle+Green Light
DeviceAll qualified subjects randomized to vehicle PDT treatment to receive up to 3 cycles of treatment.
6
Treatment groupsSee each treatment group below.
Stage One：Incidence of any local and systemic adverse events.
To compare the efficacy of multiple light doses (fluence) of Hemoporfin PDT To investigate the safety of multiple light doses (fluence) of Hemoporfin/vehicle PDT in subjects with Port-wine birthmark (PWB) in the extremities, trunk, caudal cervical, and/or retroauricular area
Stage Two: Port Wine Birthmark-Investigator Global Assessment (PWB-IGA) scale score reduction.
To compare the efficacy of multiple light doses (fluence) of Hemoporfin PDT with vehicle PDT in subjects with PWB of face and/or neck.
Stage One：Change from Baseline in overall PWB-IGA severity score and other scales.
To further evaluate the efficacy of multiple light doses (fluence) of Hemoporfin/vehicle PDT in subjects with PWB.
Stage Two: Change from Baseline in overall PWB-IGA severity score and other scales.
To further evaluate the efficacy of multiple light doses (fluence) of Hemoporfin/vehicle PDT in subjects with PWB.
Stage Two: Incidence of any local and systemic adverse events.
To investigate the safety of multiple light doses (fluence) of Hemoporfin/vehicle PDT in subjects with Port-wine birthmark (PWB)
Stage One：Maximum observed plasma concentration (Cmax) of Hemoporfin
To check what time will it take to reach the maximum contraction of Hemoporfin
Stage One：Area under the concentration-time curve (AUC 0-∞) from time 0 to infinity of Hemoporfin
To check the drug profile for absorption, distribution, metabolism and excretion for Hemoporfin
Stage One：Terminal elimination half-life (t1/2) of Hemoporfin
To check how much time Hemoporfin will take to eliminate half of it's concentration from participants.
Stage One：Time to Cmax (Tmax) of Hemoporfin
To check what will be the maximum concentration participants will obtained of Hemoporfin
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