This is a multi-center, randomized, evaluator-blinded, vehicle-controlled, and sequential group Phase 2 study. Eligible subjects aged 18 to 65 years old with PWS of face and/or neck area will receive Hemoporfin PDT or vehicle PDT in 8-week cycles at fixed drug dose and different light fluence. This is a 46 week study that includes Screening Period (4 weeks), Treatment Period (up to 3 single intravenous (IV) administration of Hemoporfin given approximately 8 weeks apart; subsequent Hemoporfin treatment is based on efficacy evaluation at the 8 week visit), and End of Study (EOS; 6 months following administration of last study drug treatment).
This is a multi-center, randomized, evaluator-blinded, vehicle-controlled, and sequential group Phase 2 study. Eligible subjects aged 18 to 65 years old with PWS of face and/or neck area will receive Hemoporfin PDT or vehicle PDT in 8-week cycles at fixed drug dose and different light fluence.