NCT05171894 A Study to Evaluate Efficacy and Safety of Light Dose in Subjects With PWB Treated With Hemoporfin PDT
| NCT ID | NCT05171894 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. |
| Condition | Port-wine Birthmarks |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2024-09-21 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 84 participants in total. It began in 2024-09-21 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05171894 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Port-wine Birthmarks. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05171894 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05171894 currently recruiting?
Yes, NCT05171894 is actively recruiting participants. Contact the research team at xjcheng@fd-zj.com for enrollment information.
Where is the NCT05171894 trial being conducted?
This trial is being conducted at Irvine, United States, San Diego, United States, Miami, United States, Hunt Valley, United States and 1 additional location.
Who is sponsoring the NCT05171894 clinical trial?
NCT05171894 is sponsored by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.. The trial plans to enroll 84 participants.