Evaluating Light Dose for Treating Port-Wine Birthmarks with Hemoporfin PDT

A Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, Sequential Group Comparison Study to Evaluate the Safety and Efficacy of Light Dose in Subjects With Port-wine Birthmarks Treated With Hemoporfin Photodynamic Therapy

This study is testing how well a new light treatment using Hemoporfin can help people with port-wine birthmarks on their face and neck.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 5 sites (Irvine, California and 4 other locations)
• Trial ID: NCT05171894 on ClinicalTrials.gov

What this trial studies

This Phase 2 clinical trial is a multi-center, randomized, double-blind, vehicle-controlled study aimed at assessing the efficacy and safety of Hemoporfin photodynamic therapy (PDT) for patients with port-wine birthmarks on the face and neck. Eligible participants aged 18 to 65 will receive either Hemoporfin PDT or a vehicle PDT in 8-week cycles, with a fixed drug dose of 5 mg/kg and varying light fluences. The study consists of two sequential stages, including a screening period, treatment period, and an end-of-study evaluation based on efficacy. The goal is to determine the optimal light dose for effective treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with clinically diagnosed port-wine birthmarks located on the face and/or neck.

Not a fit: Patients with port-wine birthmarks that do not meet the size criteria or those with other skin types outside Fitzpatrick I-VI may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the appearance of port-wine birthmarks, enhancing the quality of life for affected patients.

How similar studies have performed: Previous studies using photodynamic therapy for similar conditions have shown promising results, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Subject must be 18 to 75 years of age inclusive, at the time of signing the informed consent.
2. Subject is Fitzpatrick skin type I-VI.
3. A male subject must agree to use contraception during the Treatment Period and for at least 6 months after the last dose of study treatment and refrain from donating sperm during this period.
4. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:

   Not a woman of childbearing potential (WOCBP) . OR A WOCBP who agrees to follow the contraceptive guidance during the Treatment Period and for at least 30 days after the last dose of study treatment.
5. The subject has a clinical diagnosis of PWB located i) on the extremities, trunk, caudal cervical and/or retroauricular area (Stage One); ii) on the face and/or neck (Stage Two).
6. The longest diameter of the treatment area is ≥3 cm, and the short diameter is ≥2 cm.
7. Subject is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
8. Subject, in the Investigator's opinion, is in good general health and free of any disease state or physical condition that may impair the evaluation of PWB or expose the subject to an unacceptable risk by study participation.
9. If the subject has a history of epilepsy or seizure, the disease must remain stable for at least 6 months prior to C1D1.

Exclusion Criteria:

1. Subject is pregnant, lactating, or is planning to become pregnant during the study.
2. Subject has plaque/nodular changes and severe hypertrophy within the target PWB area.
3. Subject has Sturge-Weber syndrome.
4. Subject has any skin pathology or condition that, in the Investigator's opinion, could interfere with the evaluation of the study drug or requires use of interfering topical, systemic, or surgical therapy.
5. The subject has evidence of scarring within the target PWB area and/or the subject has a history of hypertrophic scarring or keloidal scarring.
6. Subject is immunosuppressed related to medication use and/or disease.
7. The subject has clinical abnormalities, as determined by the Investigator, which makes them unsuitable for receiving study treatment in the Investigator's opinion at Screening.
8. Subject has received any therapy on the treatment region that, in the Investigator's opinion, may affect the target PWB area.
9. Subject is known or in the opinion of the Investigator likely to be noncompliant with the requirements of the study protocol (eg, due to alcoholism, drug dependency, mental incapacity).
10. Subject has a history of either significant neurological events (such as major stroke) or a mental condition rendering him/her unable to understand the nature, scope, and possible consequences of the study.
11. Subject has an unstable cardiac disease or has any medical condition that in the opinion of the Investigator may worsen from receipt of study treatment or subject participation.
12. The subject has a history of cutaneous photosensitization, porphyria, or photodermatosis.
13. The subject has the need or has plans to be exposed to artificial tanning devices or excessive sunlight during the study.

Where this trial is running

Irvine, California and 4 other locations

• UCI Health Beckman Laser Institute & Medical Clinic — Irvine, California, United States (Recruiting)
• Dermatology Cosmetic Associates of La Jolla, Inc. d/b/a West Dermatology Research Center — San Diego, California, United States (Recruiting)
• Miami Dermatology and Laser Institute — Miami, Florida, United States (Recruiting)
• Maryland Dermatology, Laser, Skin & Vein Institute — Hunt Valley, Maryland, United States (Recruiting)
• St. Luke's University Health Network — Bethlehem, Pennsylvania, United States (Recruiting)

Study contacts

• Study coordinator: Xuejing Cheng

Conditions Port-wine Birthmarks; Port-Wine Stain; Nevus Flammeus; Hemoporfin; Photodynamic therapy