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

March 2, 2026 updated by: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92697
        • Recruiting
        • UCI Health Beckman Laser Institute & Medical Clinic
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kristen M. Kelly
      • San Diego, California, United States, 92121
        • Recruiting
        • Dermatology Cosmetic Associates of La Jolla, Inc. d/b/a West Dermatology Research Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sabrina G. Fabi
    • Florida
      • Miami, Florida, United States, 33173
    • Maryland
      • Hunt Valley, Maryland, United States, 21030
        • Recruiting
        • Maryland Dermatology, Laser, Skin & Vein Institute
        • Principal Investigator:
          • Robert A. Weiss
        • Contact:
        • Contact:
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Recruiting
        • St. Luke's University Health Network
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andrew C. Krakowski

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: Hemopfin+Green Light
All qualified subjects randomized to Hemoporfin PDT treatment to receive up to 3 cycles of treatment.
Other Names:
  • Hemopfin photodynamic therapy
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.
Drug: Hemopfin+Green Light
All qualified subjects randomized to Hemoporfin PDT treatment to receive up to 3 cycles of treatment.
Other Names:
  • Hemopfin photodynamic therapy
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.
Drug: Hemopfin+Green Light
All qualified subjects randomized to Hemoporfin PDT treatment to receive up to 3 cycles of treatment.
Other Names:
  • Hemopfin photodynamic therapy
Placebo Comparator: Placebo+A J/cm2 Green Light
Participants will receive Vehicle (Saline) via intravenous (IV) infusion and fixed laser irradiation for certain time.
Device: Vehicle+Green Light
All qualified subjects randomized to vehicle PDT treatment to receive up to 3 cycles of treatment.
Other Names:
  • saline photodynamic therapy
Placebo Comparator: Placebo+B J/cm2 Green Light
Participants will receive Vehicle (Saline) via intravenous (IV) infusion and fixed laser irradiation for certain time.
Device: Vehicle+Green Light
All qualified subjects randomized to vehicle PDT treatment to receive up to 3 cycles of treatment.
Other Names:
  • saline photodynamic therapy
Placebo Comparator: Placebo+C J/cm2 Green Light
Participants will receive Vehicle (Saline) via intravenous (IV) infusion and fixed laser irradiation for certain time.
Device: Vehicle+Green Light
All qualified subjects randomized to vehicle PDT treatment to receive up to 3 cycles of treatment.
Other Names:
  • saline photodynamic therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Stage Two: Port Wine Birthmark-Investigator Global Assessment (PWB-IGA) scale score reduction.
Time Frame: From baseline until end of study, up to approximately 44 weeks
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
Stage One：Incidence of any local and systemic adverse events.
Time Frame: From baseline until end of study, up to approximately 44 weeks
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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Stage One：Change from Baseline in overall PWB-IGA severity score and other scales.
Time Frame: From baseline until end of study, up to approximately 44 weeks
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.
Time Frame: From baseline until end of study, up to approximately 44 weeks
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.
Time Frame: From baseline until end of study, up to approximately 44 weeks
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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Stage One：Maximum observed plasma concentration (Cmax) of Hemoporfin
Time Frame: On the first day of the Cycle 1 (each cycle is 56 days)
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
Time Frame: On the first day of the Cycle 1 (each cycle is 56 days)
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
Time Frame: On the first day of the Cycle 1 (each cycle is 56 days)
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
Time Frame: On the first day of the Cycle 1 (each cycle is 56 days)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 21, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 15, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 29, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • F0026-US201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

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