A Study to Evaluate Efficacy and Safety of Light Dose in Subjects With PWB Treated With Hemoporfi… (NCT05171894) | Clinical Trial Compass
RecruitingPhase 2
A Study to Evaluate Efficacy and Safety of Light Dose in Subjects With PWB Treated With Hemoporfin PDT
United States84 participantsStarted 2024-09-21
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subject must be 18 to 75 years of age inclusive, at the time of signing the informed consent.
✓. Subject is Fitzpatrick skin type I-VI.
✓. 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.
✓. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
✓. 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).
✓. The longest diameter of the treatment area is ≥3 cm, and the short diameter is ≥2 cm.
✓. 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.
✓. 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.
Exclusion criteria
✕. Subject is pregnant, lactating, or is planning to become pregnant during the study.
✕. Subject has plaque/nodular changes and severe hypertrophy within the target PWB area.
What they're measuring
1
Stage One：Incidence of any local and systemic adverse events.
Timeframe: From baseline until end of study, up to approximately 44 weeks
2
Stage Two: Port Wine Birthmark-Investigator Global Assessment (PWB-IGA) scale score reduction.
Timeframe: From baseline until end of study, up to approximately 44 weeks
✕. 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.
✕. The subject has evidence of scarring within the target PWB area and/or the subject has a history of hypertrophic scarring or keloidal scarring.
✕. Subject is immunosuppressed related to medication use and/or disease.
✕. 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.
✕. Subject has received any therapy on the treatment region that, in the Investigator's opinion, may affect the target PWB area.