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
Who is this study for? Patients with Port-Wine Stain, Nevus Flammeus
What treatments are being studied? PDF
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This is a multi-center, randomized, double-blind, vehicle-controlled, and sequential group Phase 2 study. Eligible subjects aged 18 to 65 years old with PWB of face and/or neck area (except subjects for Stage One) will receive Hemoporfin PDT or vehicle PDT in 8-week cycles at fixed drug dose (5 mg/kg) and different light fluence.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Subject must be 18 to 65 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:
• 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.
• The subject has a clinical diagnosis of PWB located on the face and/or neck.
• 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.
Locations
United States
California
UCI Health Beckman Laser Institute & Medical Clinic
NOT_YET_RECRUITING
Irvine
Dermatology Cosmetic Associates of La Jolla, Inc. d/b/a West Dermatology Research Center
RECRUITING
San Diego
Florida
Skin and Cancer Associates (SCA) and the Center for Cosmetic Enhancement (CCE)
RECRUITING
Aventura
Miami Dermatology and Laser Institute
RECRUITING
Miami
Maryland
Maryland Dermatology, Laser, Skin & Vein Institute
RECRUITING
Hunt Valley
Pennsylvania
St. Luke's University Health Network
NOT_YET_RECRUITING
Bethlehem
Contact Information
Primary
Xuejing Cheng
xjcheng@fd-zj.com
00-86-021-58953355
Time Frame
Start Date:2024-09-21
Estimated Completion Date:2026-04
Participants
Target number of participants:84
Treatments
Experimental: Hemoporfin+A J/cm2 Green Light
Participants will receive Hemoporfin 5 mg/kg of body weight via intravenous (IV) infusion and fixed laser irradiation for certain time.
Experimental: Hemoporfin+B J/cm2 Green Light
Participants will receive Hemoporfin 5 mg/kg of body weight via intravenous (IV) infusion and fixed laser irradiation for certain time.
Experimental: Hemoporfin+C J/cm2 Green Light
Participants will receive Hemoporfin 5 mg/kg of body weight via intravenous (IV) infusion and fixed laser irradiation for certain time.
Placebo_comparator: Placebo+A J/cm2 Green Light
Participants will receive Vehicle (Saline) via intravenous (IV) infusion and fixed laser irradiation for certain time.
Placebo_comparator: Placebo+B J/cm2 Green Light
Participants will receive Vehicle (Saline) via intravenous (IV) infusion and fixed laser irradiation for certain time.
Placebo_comparator: Placebo+C J/cm2 Green Light
Participants will receive Vehicle (Saline) via intravenous (IV) infusion and fixed laser irradiation for certain time.