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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.
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 cycles at fixed drug dose (5 mg/kg) and different light fluences. This study will be conducted in two sequential stages, each contains the same schedule, which includes Screening Period, Treatment Period apart; subsequent treatment is based on efficacy evaluation, and End of Study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemoporfin+A J/cm2 Green Light | Experimental | Participants will receive Hemoporfin 5 mg/kg of body weight via intravenous (IV) infusion and fixed laser irradiation for certain time. |
|
| Hemoporfin+B J/cm2 Green Light | Experimental | Participants will receive Hemoporfin 5 mg/kg of body weight via intravenous (IV) infusion and fixed laser irradiation for certain time. |
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| Hemoporfin+C J/cm2 Green Light | Experimental | Participants will receive Hemoporfin 5 mg/kg of body weight via intravenous (IV) infusion and fixed laser irradiation for certain time. |
|
| Placebo+A J/cm2 Green Light | Placebo Comparator | Participants will receive Vehicle (Saline) via intravenous (IV) infusion and fixed laser irradiation for certain time. |
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| Placebo+B J/cm2 Green Light | Placebo Comparator | Participants will receive Vehicle (Saline) via intravenous (IV) infusion and fixed laser irradiation for certain time. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemopfin+Green Light | Drug | All qualified subjects randomized to Hemoporfin PDT treatment to receive up to 3 cycles of treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stage One:Incidence of any local and systemic adverse events. | To compare the efficacy of multiple light doses (fluence) of Hemoporfin PDT To investigate the safety of multiple light doses (fluence) of Hemoporfin/vehicle PDT in subjects with Port-wine birthmark (PWB) in the extremities, trunk, caudal cervical, and/or retroauricular area | From baseline until end of study, up to approximately 44 weeks |
| Stage Two: Port Wine Birthmark-Investigator Global Assessment (PWB-IGA) scale score reduction. | To compare the efficacy of multiple light doses (fluence) of Hemoporfin PDT with vehicle PDT in subjects with PWB of face and/or neck. | From baseline until end of study, up to approximately 44 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Stage One:Change from Baseline in overall PWB-IGA severity score and other scales. | To further evaluate the efficacy of multiple light doses (fluence) of Hemoporfin/vehicle PDT in subjects with PWB. | From baseline until end of study, up to approximately 44 weeks |
| Stage Two: Change from Baseline in overall PWB-IGA severity score and other scales. |
| Measure | Description | Time Frame |
|---|---|---|
| Stage One:Maximum observed plasma concentration (Cmax) of Hemoporfin | To check what time will it take to reach the maximum contraction of Hemoporfin | On the first day of the Cycle 1 (each cycle is 56 days) |
| Stage One:Area under the concentration-time curve (AUC 0-∞) from time 0 to infinity of Hemoporfin |
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:
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 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.
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xuejing Cheng | Contact | 00-86-021-58953355 | xjcheng@fd-zj.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCI Health Beckman Laser Institute & Medical Clinic | Recruiting | Irvine | California | 92697 | United States |
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| Placebo+C J/cm2 Green Light | Placebo Comparator | Participants will receive Vehicle (Saline) via intravenous (IV) infusion and fixed laser irradiation for certain time. |
|
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| Vehicle+Green Light | Device | All qualified subjects randomized to vehicle PDT treatment to receive up to 3 cycles of treatment. |
|
|
To further evaluate the efficacy of multiple light doses (fluence) of Hemoporfin/vehicle PDT in subjects with PWB. |
| From baseline until end of study, up to approximately 44 weeks |
| Stage Two: Incidence of any local and systemic adverse events. | To investigate the safety of multiple light doses (fluence) of Hemoporfin/vehicle PDT in subjects with Port-wine birthmark (PWB) | From baseline until end of study, up to approximately 44 weeks |
To check the drug profile for absorption, distribution, metabolism and excretion for Hemoporfin |
| On the first day of the Cycle 1 (each cycle is 56 days) |
| Stage One:Terminal elimination half-life (t1/2) of Hemoporfin | To check how much time Hemoporfin will take to eliminate half of it's concentration from participants. | On the first day of the Cycle 1 (each cycle is 56 days) |
| Stage One:Time to Cmax (Tmax) of Hemoporfin | To check what will be the maximum concentration participants will obtained of Hemoporfin | On the first day of the Cycle 1 (each cycle is 56 days) |
| Dermatology Cosmetic Associates of La Jolla, Inc. d/b/a West Dermatology Research Center | Recruiting | San Diego | California | 92121 | United States |
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| Miami Dermatology and Laser Institute | Recruiting | Miami | Florida | 33173 | United States |
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| Maryland Dermatology, Laser, Skin & Vein Institute | Recruiting | Hunt Valley | Maryland | 21030 | United States |
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| St. Luke's University Health Network | Recruiting | Bethlehem | Pennsylvania | 18015 | United States |
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| ID | Term |
|---|---|
| D019339 | Port-Wine Stain |
| ID | Term |
|---|---|
| D012868 | Skin Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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