Port-wine BirthmarksPhase 2NCT05171894
A Study to Evaluate Efficacy and Safety of Light Dose in Subjects With PWB Treated With Hemoporfin PDT
A Phase 2 study testing Hemopfin+Green Light in people with Port-wine Birthmarks and Port-Wine Stain, run by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Port-wine Birthmarks, Port-Wine Stain, Nevus Flammeus
- What is being tested?
- Hemopfin+Green Light
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 5 sitesUnited States
- Study dates
- 21 Sep 2024to Apr 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Show all 10Show fewer
- 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.
Who cannot join
- 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.
- Subject has Sturge-Weber syndrome.
- 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.
Show all 13Show fewer
- 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.
- 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).
- 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.
- 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.
- The subject has a history of cutaneous photosensitization, porphyria, or photodermatosis.
- The subject has the need or has plans to be exposed to artificial tanning devices or excessive sunlight during the study.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
St. Luke's University Health Network
Bethlehem, Pennsylvania, 18015
Andrew C. Krakowski, 484-503-7546, Andrew.Krakowski@sluhn.org
Jasdip Kaur, 484-658-1828, Jasdip.Kaur@sluhn.org
- Recruiting
Maryland Dermatology, Laser, Skin & Vein Institute
Hunt Valley, Maryland, 21030
Robert A. Weiss, 410-666-3960, rweiss@mdlsv.com
Cristi L. Myers, 410-666-2839, cmyers@mdlsv.com
- Recruiting
UCI Health Beckman Laser Institute & Medical Clinic
Irvine, California, 92697
Kristen M. Kelly, 949-824-7103, kmkelly@hs.uci.edu
Marcos Hurtado, 949-824-7103, marcosh3@hs.uci.edu
- Recruiting
Miami Dermatology and Laser Institute
Miami, Florida, 33173
Jill S. Waibel, (561) 313-1457, jwaibelmd@miamidermlaser.com
Peter Illes, 305-279-6060, PeterI@miamidermlaser.com
- Recruiting
Dermatology Cosmetic Associates of La Jolla, Inc. d/b/a West Dermatology Research Center
San Diego, California, 92121
Sabrina G. Fabi, 858-657-1004, sfabi@clderm.com
Kennedi Stewart, 858-657-1004, kstewart@clderm.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Port-wine Birthmarks, Port-Wine Stain, Nevus Flammeus
- Being tested
- Hemopfin+Green Light, Vehicle+Green Light
- Keywords
- Hemoporfin, Port-wine Birthmarks, Port-Wine Stain, Nevus Flammeus, Photodynamic therapy
- Medical subject headings
- Port-Wine Stain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemopfin+Green LightDrug
Also called Hemopfin photodynamic therapy
All qualified subjects randomized to Hemoporfin PDT treatment to receive up to 3 cycles of treatment.
Vehicle+Green LightDevice
Also called saline photodynamic therapy
All qualified subjects randomized to vehicle PDT treatment to receive up to 3 cycles of treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Hemopfin+Green Light |
| 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. Receives: Drug: Hemopfin+Green Light |
| 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. Receives: Drug: Hemopfin+Green Light |
| Placebo+A J/cm2 Green Light | Placebo comparator | Participants will receive Vehicle (Saline) via intravenous (IV) infusion and fixed laser irradiation for certain time. Receives: Device: Vehicle+Green Light |
| Placebo+B J/cm2 Green Light | Placebo comparator | Participants will receive Vehicle (Saline) via intravenous (IV) infusion and fixed laser irradiation for certain time. Receives: Device: Vehicle+Green Light |
| Placebo+C J/cm2 Green Light | Placebo comparator | Participants will receive Vehicle (Saline) via intravenous (IV) infusion and fixed laser irradiation for certain time. Receives: Device: Vehicle+Green Light |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: From baseline until end of study, up to approximately 44 weeks
Secondary outcomes (3)
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.
Measured: 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.
To further evaluate the efficacy of multiple light doses (fluence) of Hemoporfin/vehicle PDT in subjects with PWB.
Measured: 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)
Measured: From baseline until end of study, up to approximately 44 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start21 Sep 2024
- Primary completionJan 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Port-wine BirthmarksStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05171894
- Sponsor's protocol ID
- F0026-US201
- Status last verified
- Nov 2025
- First submitted
- 15 Nov 2021
- Last updated
- 3 Mar 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05171894
- Acronym / sponsor ID
- F0026-US201
- Conditions
- Port-wine Birthmarks, Port-Wine Stain, Nevus Flammeus
- Keywords
- Hemoporfin, Port-wine Birthmarks, Port-Wine Stain, Nevus Flammeus, Photodynamic therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Sep 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 29 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Hemoporfin+A J/cm2 Green Light | Experimental | Drug: Hemopfin+Green LightParticipants 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 | Drug: Hemopfin+Green LightParticipants will receive Hemoporfin 5 mg/kg of body weight via intravenous (IV) infusion and fixed laser irradiation for certain time. |
| Hemoporfin+C J/cm2 Green Light | Experimental | Drug: Hemopfin+Green LightParticipants 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 | Device: Vehicle+Green LightParticipants will receive Vehicle (Saline) via intravenous (IV) infusion and fixed laser irradiation for certain time. |
| Placebo+B J/cm2 Green Light | Placebo comparator | Device: Vehicle+Green LightParticipants will receive Vehicle (Saline) via intravenous (IV) infusion and fixed laser irradiation for certain time. |
| Placebo+C J/cm2 Green Light | Placebo comparator | Device: Vehicle+Green LightParticipants will receive Vehicle (Saline) via intravenous (IV) infusion and fixed laser irradiation for certain time. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
- Subject has Sturge-Weber syndrome.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemopfin+Green LightAlso: Hemopfin photodynamic therapyAll qualified subjects randomized to Hemoporfin PDT treatment to receive up to 3 cycles of treatment. | Drug | Hemoporfin+A J/cm2 Green Light, Hemoporfin+B J/cm2 Green Light, Hemoporfin+C J/cm2 Green Light |
| Vehicle+Green LightAlso: saline photodynamic therapyAll qualified subjects randomized to vehicle PDT treatment to receive up to 3 cycles of treatment. | Device | Placebo+A J/cm2 Green Light, Placebo+B J/cm2 Green Light, Placebo+C J/cm2 Green Light |
Primary outcome
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
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.
3 secondary outcomes
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
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
Stage Two: Incidence of any local and systemic adverse events.
Time frame: From baseline until end of study, up to approximately 44 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
Related trials for Port-wine Birthmarks
Recruiting
Maximizing Laser Therapy Success for Port-Wine Birthmarks in Pediatric Patients
Port Wine Stains
Recruiting
AdvaTx Laser Treatment for Vascular Birthmarks
Port-wine Stains (PWS), Vascular Birthmark
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hemopfin+Green Light in people with Port-wine Birthmarks and Port-Wine Stain, run by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xuejing Cheng (00-86-021-58953355, xjcheng@fd-zj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stage One：Incidence of any local and systemic adverse events. (time frame: From baseline until end of study, up to approximately 44 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.