Spots Global Cancer Trial Database for A Study to Evaluate Efficacy and Safety of Light Dose in Subjects With PWB Treated With Hemoporfin + PDT

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Trial Identification

Brief Title: A Study to Evaluate Efficacy and Safety of Light Dose in Subjects With PWB Treated With Hemoporfin + PDT

Official Title: A Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, Sequential Group Comparison Study to Evaluate the Safety and Efficacy of Light Dose (Fluence) in Subjects With Port-wine Birthmark of the Face and/or Neck Treated With Hemoporfin + Green Light Photodynamic Therapy

Study ID: NCT05171894

Conditions

Port-wine Birthmark

Port-Wine Stain

Nevus Flammeus

Interventions

Hemopfin+PDT

Vehicle+PDT

Study Description

Brief Summary: This is a multi-center, randomized, double-blind, vehicle-controlled, and sequential group Phase 2 study. Eligible subjects aged 18 to 65 years old with PWB of face and/or neck area (except subjects for Stage One) will receive Hemoporfin PDT or vehicle PDT in 8-week cycles at fixed drug dose (5 mg/kg) and different light fluence.

Detailed Description: This is a multi-center, randomized, double-blind, vehicle-controlled, and sequential group Phase 2 study. Eligible subjects aged 18 to 65 years old with PWB of face and/or neck area (except subjects for Stage One) 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.