Actively Recruiting
A Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, Sequential Group Study to Evaluate Safety and Efficacy of Light Dose in Adults With Port-Wine Birthmarks Treated With Hemoporfin Photodynamic Therapy
Led by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. · Updated on 2026-03-03
84
Participants Needed
5
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of different light doses in treating adults aged 18 to 75 with Port-Wine Birthmarks PWB. The study is a multi-center, randomized, double-blind, vehicle-controlled Phase 2 trial conducted in two sequential stages. It focuses on comparing Hemoporfin photodynamic therapy PDT with a vehicle placebo control using fixed drug dosing and varying light fluences. Participants will be randomly assigned to receive either Hemoporfin PDT or vehicle PDT via intravenous infusion at a fixed dose of 5 mgkg. They will undergo fixed laser irradiation for a set time in cycles lasting 8 weeks. Each participant may receive up to three treatment cycles. The study consists of a Screening Period, Treatment Period, efficacy evaluation for subsequent treatment, and an End of Study phase, lasting up to approximately 44 weeks. Throughout the study, participants will be closely monitored for local and systemic adverse events. Researchers will assess changes in PWB severity using the Port Wine Birthmark-Investigator Global Assessment PWB-IGA scale and other measures from baseline until the studys end. Regular evaluations include physical exams, safety assessments, and efficacy reviews, ensuring participant health and adherence over the entire study duration.
CONDITIONS
Brief Title
A Study to Evaluate Efficacy and Safety of Light Dose in Subjects With PWB Treated With Hemoporfin PDT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years at time of consent
- Fitzpatrick skin type I to VI
- Men must agree to contraception during treatment and for 6 months after last dose
- Women must not be pregnant or breastfeeding and either not of childbearing potential or agree to contraception during treatment and for 30 days after last dose
- Clinical diagnosis of PWB on extremities, trunk, neck, face, or retroauricular area
- Treatment area longest diameter at least 3 cm and short diameter at least 2 cm
- Able to provide informed consent and follow study requirements
- In good general health without conditions impairing PWB evaluation or increasing risk
- Stable epilepsy or seizure history for at least 6 months prior to treatment start
You will not qualify if you...
- Pregnant, lactating, or planning pregnancy during study
- Plaque or nodular changes and severe hypertrophy in target PWB area
- Diagnosis of Sturge-Weber syndrome
- Skin conditions interfering with evaluation or requiring conflicting treatments
- History or evidence of scarring, hypertrophic or keloidal in target area
- Immunosuppression due to medication or disease
- Clinical abnormalities making study treatment unsuitable
- Previous treatments affecting target area
- Known or likely noncompliance with study protocol
- Significant neurological events or mental conditions impairing consent or understanding
- Unstable cardiac disease or medical conditions worsening with treatment
- History of photosensitivity, porphyria, or photodermatosis
- Need or plans for artificial tanning or excessive sunlight exposure during study
Research Team
X
Xuejing Cheng
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