Recruiting
Phase 2

Hemoporfin PDT

Sponsor:

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

Code:

NCT05171894

Conditions

Port-wine Birthmarks

Port-Wine Stain

Nevus Flammeus

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Hemopfin+Green Light

Vehicle+Green Light

Study Details

Brief 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.

Conditions

Port-wine Birthmarks

Port-Wine Stain

Nevus Flammeus

Study ID

NCT05171894

Start date

Sep 21, 2024

Status verified date

Nov, 2025

Completion date

Apr, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

84 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Hemopfin+Green Light

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

Vehicle+Green Light

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

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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Locations

UCI Health Beckman Laser Institute & Medical Clinic

Recruiting

Irvine, California, United States, 92697

Contacts

Principal Investigator:

Kristen M. Kelly

Dermatology Cosmetic Associates of La Jolla, Inc. d/b/a West Dermatology Research Center

Recruiting

San Diego, California, United States, 92121

Contacts

Principal Investigator:

Sabrina G. Fabi

Miami Dermatology and Laser Institute

Recruiting

Miami, Florida, United States, 33173

Contacts

Principal Investigator:

Jill S. Waibel

Maryland Dermatology, Laser, Skin & Vein Institute

Recruiting

Hunt Valley, Maryland, United States, 21030

Contacts

Principal Investigator:

Robert A. Weiss

St. Luke's University Health Network

Recruiting

Bethlehem, Pennsylvania, United States, 18015

Contacts

Principal Investigator:

Andrew C. Krakowski

More Information

Sponsor

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

Last update posted

Mar 3, 2026

Last verified

Nov, 2025

Keywords

  • Hemoporfin
  • Port-wine Birthmarks
  • Port-Wine Stain
  • Nevus Flammeus
  • Photodynamic therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. on 2026-03-03.