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.
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Treatment groupsSee each treatment group below.