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.
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 cycles at fixed drug dose (5 mg/kg) and different light fluences. This study will be conducted in two sequential stages, each contains the same schedule, which includes Screening Period, Treatment Period apart; subsequent treatment is based on efficacy evaluation, and End of Study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
84
All qualified subjects randomized to Hemoporfin PDT treatment to receive up to 3 cycles of treatment.
All qualified subjects randomized to vehicle PDT treatment to receive up to 3 cycles of treatment.
UCI Health Beckman Laser Institute & Medical Clinic
Irvine, California, United States
NOT_YET_RECRUITINGDermatology Cosmetic Associates of La Jolla, Inc. d/b/a West Dermatology Research Center
San Diego, California, United States
RECRUITINGMiami Dermatology and Laser Institute
Miami, Florida, United States
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
Time frame: From baseline until end of study, up to approximately 44 weeks
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.
Time frame: From baseline until end of study, up to approximately 44 weeks
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.
Time frame: From baseline until end of study, up to approximately 44 weeks
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.
Time frame: From baseline until end of study, up to approximately 44 weeks
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)
Time frame: From baseline until end of study, up to approximately 44 weeks
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Maryland Dermatology, Laser, Skin & Vein Institute
Hunt Valley, Maryland, United States
RECRUITINGSt. Luke's University Health Network
Bethlehem, Pennsylvania, United States
NOT_YET_RECRUITING