A Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, Sequential Group Comparison Study to Evaluate the Safety and Efficacy of Light Dose in Subjects With Port-wine Birthmarks Treated With Hemoporfin Photodynamic Therapy
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Summary
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.
Description
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.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Subject must be 18 to 75 years of age inclusive, at the time of signing the informed consent. 2. Subject is Fitzpatrick skin type I-VI. 3. 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. 4. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) . OR A WOCBP who agrees to follow the contraceptive…
Interventions
- DrugHemopfin+Green Light
All qualified subjects randomized to Hemoporfin PDT treatment to receive up to 3 cycles of treatment.
- DeviceVehicle+Green Light
All qualified subjects randomized to vehicle PDT treatment to receive up to 3 cycles of treatment.
Locations (5)
- UCI Health Beckman Laser Institute & Medical ClinicIrvine, California
- Dermatology Cosmetic Associates of La Jolla, Inc. d/b/a West Dermatology Research CenterSan Diego, California
- Miami Dermatology and Laser InstituteMiami, Florida
- Maryland Dermatology, Laser, Skin & Vein InstituteHunt Valley, Maryland
- St. Luke's University Health NetworkBethlehem, Pennsylvania