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

NCT05171894 | Recruiting Phase 2 FDA Drug FDA Device

• 1 other identifier: F0026-US201
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 5

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• Stage One：Change from Baseline in overall PWB-IGA severity score and other scales.

  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.

  From baseline until end of study, up to approximately 44 weeks

• Stage Two: Incidence of any local and systemic adverse events.

  From baseline until end of study, up to approximately 44 weeks

Other Outcomes (4)

• Stage One：Maximum observed plasma concentration (Cmax) 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

  On the first day of the Cycle 1 (each cycle is 56 days)

• Stage One：Terminal elimination half-life (t1/2) of Hemoporfin

  On the first day of the Cycle 1 (each cycle is 56 days)

Study Arms (6)

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.

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.

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.

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.

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.

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.

Device: Vehicle+Green Light

Interventions

Vehicle+Green Light DEVICE

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

Also known as: saline photodynamic therapy

Placebo+A J/cm2 Green Light; Placebo+B J/cm2 Green Light; Placebo+C J/cm2 Green Light

Hemopfin+Green Light DRUG

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

Also known as: Hemopfin photodynamic therapy

Hemoporfin+A J/cm2 Green Light; Hemoporfin+B J/cm2 Green Light; Hemoporfin+C J/cm2 Green Light

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.: lead

Study Sites (5)

UCI Health Beckman Laser Institute & Medical Clinic

Irvine, California, 92697, United States

RECRUITING

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

San Diego, California, 92121, United States

RECRUITING

Miami Dermatology and Laser Institute

Miami, Florida, 33173, United States

RECRUITING

Maryland Dermatology, Laser, Skin & Vein Institute

Hunt Valley, Maryland, 21030, United States

RECRUITING

St. Luke's University Health Network

Bethlehem, Pennsylvania, 18015, United States

RECRUITING

MeSH Terms

Conditions

Port-Wine Stain

Condition Hierarchy (Ancestors)

Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Xuejing Cheng

CONTACT

00-86-021-58953355; xjcheng@fd-zj.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: December 29, 2021
• Study Start: September 21, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 3, 2026

Record last verified: 2025-11

Locations

US (5)