Clinical Trial

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

Recruiting Phase 2
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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.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2021-12-10; most recent amendment 2026-03-02.
Status change: Not Yet Recruiting → Recruiting 2024-07-29
Trial Details
NCT Number NCT05171894
Lead Sponsor Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Conditions Port-wine Birthmarks, Port-Wine Stain, Nevus Flammeus
Enrollment 84 participants
Start Date 2024-09-21
Primary Completion 2027-01 (estimated)
Study Completion 2027-04 (estimated)
Updated on ClinicalTrials.gov 2026-03-03