Actively Recruiting
Study to Evaluate Safety and Effectiveness of Hemoporfin Photodynamic Therapy Using Different Light Doses in Adults with Port-Wine Birthmarks
Led by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. · Updated on 2026-03-03
84
Participants Needed
5
Research Sites
131 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of different light doses in treating adults aged 18 to 75 years with Port-Wine Birthmarks (PWB) using Hemoporfin photodynamic therapy (PDT). This Phase 2 study is multi-center, randomized, double-blind, and vehicle-controlled, designed to compare Hemoporfin PDT with a placebo (vehicle PDT) under various light fluence conditions. Participants have PWB located on specific body areas, and the study aims to assess both local and systemic side effects as well as improvements in PWB appearance. Participants will be randomly assigned to receive either Hemoporfin PDT or vehicle PDT, administered in cycles lasting 8 weeks each with a fixed drug dose of 5 mg/kg. The study is conducted in two sequential stages, each including a Screening Period, a Treatment Period, and an End of Study evaluation. Treatments may be repeated for up to three cycles based on efficacy assessments, with different light fluences applied during therapy to evaluate optimal dosing. Throughout the study, participants will undergo regular assessments including monitoring for any adverse events from baseline up to approximately 44 weeks. Researchers will evaluate changes in PWB severity using the Investigator Global Assessment scale. Participants must comply with study procedures, including clinical evaluations and safety monitoring. The study duration covers screening, treatment cycles, and follow-up to ensure thorough safety and efficacy data collection.
CONDITIONS
Official 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 inclusive at signing informed consent
- Fitzpatrick skin type I to VI
- Male participants agree to use contraception during treatment and for 6 months after last dose, and avoid sperm donation during this period
- Female participants must not be pregnant or breastfeeding and either not be of childbearing potential or agree to contraception during treatment and for 30 days after last dose
- Clinical diagnosis of Port-Wine Birthmark located on extremities, trunk, caudal cervical, retroauricular area (Stage One) or face and/or neck (Stage Two)
- Treatment area longest diameter at least 3 cm and short diameter at least 2 cm
- Able to provide signed informed consent and comply with study requirements
- In good general health without conditions impairing evaluation or posing unacceptable risk
- If history of epilepsy or seizure, condition must be stable for at least 6 months prior to first dose
You will not qualify if you...
- Pregnant, lactating, or planning pregnancy during the study
- Presence of plaque, nodular changes, or severe hypertrophy in target Port-Wine Birthmark area
- Diagnosis of Sturge-Weber syndrome
- Skin conditions interfering with evaluation or requiring conflicting therapies
- Evidence or history of scarring (hypertrophic or keloidal) in target area
- Immunosuppression due to disease or medications
- Clinical abnormalities making treatment unsafe or unsuitable
- Prior therapies on treatment area that may affect study evaluation
- Likely noncompliance due to alcoholism, drug dependency, or mental incapacity
- History of major neurological events or mental conditions impairing understanding of study
- Unstable cardiac disease or medical conditions that may worsen with treatment
- History of photosensitization, porphyria, or photodermatosis
- Plans for artificial tanning or excessive sunlight exposure during study
AI-Screening
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Trial Site Locations
Total: 5 locations
1
UCI Health Beckman Laser Institute & Medical Clinic
Irvine, California, United States, 92697
Actively Recruiting
2
Dermatology Cosmetic Associates of La Jolla, Inc. d/b/a West Dermatology Research Center
San Diego, California, United States, 92121
Actively Recruiting
3
Miami Dermatology and Laser Institute
Miami, Florida, United States, 33173
Actively Recruiting
4
Maryland Dermatology, Laser, Skin & Vein Institute
Hunt Valley, Maryland, United States, 21030
Actively Recruiting
5
St. Luke's University Health Network
Bethlehem, Pennsylvania, United States, 18015
Actively Recruiting
Research Team
X
Xuejing Cheng
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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