Actively Recruiting
A Study to Evaluate Efficacy and Safety of Light Dose in Subjects With PWB Treated With Hemoporfin PDT
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
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.
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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