Symptoms and General Pathology

All Conditions

Neoplasms

Diseases and Abnormalities at or Before Birth

Skin and Connective Tissue Diseases

Facies

Hemangioma, Capillary

Port-Wine Stain

Nevus, Pigmented

Nevus

Hemangioma

Congenital Abnormalities

Skin Abnormalities

Skin Diseases

Neoplasms, Vascular Tissue

Neoplasms by Histologic Type

Participants will receive Hemoporfin 5 mg/kg of body weight via intravenous (IV) infusion and fixed laser irradiation for certain time.

Participants will receive Vehicle (Saline) via intravenous (IV) infusion and fixed laser irradiation for certain time.

All qualified subjects randomized to Hemoporfin PDT treatment to receive up to 3 cycles of treatment.

Hemopfin+PDT

All qualified subjects randomized to vehicle PDT treatment to receive up to 3 cycles of treatment.

Vehicle+PDT

Xuejing Cheng

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.

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 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.

A Study to Evaluate Efficacy and Safety of Light Dose in Subjects With PWB Treated With Hemoporfin + PDT

A Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, Sequential Group Comparison Study to Evaluate the Safety and Efficacy of Light Dose (Fluence) in Subjects With Port-wine Birthmark of the Face and/or Neck Treated With Hemoporfin + Green Light Photodynamic Therapy

To check what time will it take to reach the maximum contraction of Hemoporfin

To check the drug profile for absorption, distribution, metabolism and excretion for Hemoporfin

To check how much time Hemoporfin will take to eliminate half of it's concentration from participants.

To check what will be the maximum concentration participants will obtained of Hemoporfin

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)

To compare the efficacy of multiple light doses (fluence) of Hemoporfin PDT with vehicle PDT in subjects with PWB of face and/or neck.

To further evaluate the efficacy of multiple light doses (fluence) of Hemoporfin/vehicle PDT in subjects with PWB.

To investigate the safety of multiple light doses (fluence) of Hemoporfin/vehicle PDT in subjects with Port-wine birthmark (PWB)

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

Hemoporfin

Xuejun Zhu

Jining Tao

This study is to provide safety information of hemoporfin during the post-marketing period as required by China Food and Drug Administration (CFDA) regulations in order to identify any potential drug related treatment factors in the Chinese population, such as unknown/unexpected adverse reactions, the incidence of adverse reactions under the routine drug uses.

Postmarketing Safety Study of Hemoporfin in Patients With Port Wine Stain

proportion of patients achieving at least some improvement (color blanching from the baseline \>= 20%)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Evaluate Efficacy and Safety of Light Dose in Subjects With PWB Treated With Hemoporfin + PDT	NCT05171894	Port-wine Birth... Port-Wine Stain Nevus Flammeus	Hemopfin+PDT Vehicle+PDT	18 Years - 65 Years	Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Postmarketing Safety Study of Hemoporfin in Patients With Port Wine Stain	NCT03181984	Port-Wine Stain	Hemoporfin	14 Years - 65 Years	Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Postmarketing Safety Study of Hemoporfin in Patients With Port Wine Stain	NCT03181984	Port-Wine Stain	Hemoporfin	14 Years - 65 Years	Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

Spots Global Cancer Trial Database for hemoporfin

Every month we try and update this database with for hemoporfin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for hemoporfin

Every month we try and update this database with for hemoporfin cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for hemoporfin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.