RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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 8-week cycles at fixed drug dose (5 mg/kg) and different light fluence.

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

Quick Facts

Study Start:2024-09-21

Study Completion:2027-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05171894

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.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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: 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.	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.

Inclusion Criteria

Exclusion 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:
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.

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.

Contacts and Locations

Study Contact

Xuejing Cheng

CONTACT

00-86-021-58953355

xjcheng@fd-zj.com

Study Locations (Sites)

UCI Health Beckman Laser Institute & Medical Clinic

Irvine, California, 92697

United States

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

San Diego, California, 92121

United States

Miami Dermatology and Laser Institute

Miami, Florida, 33173

United States

Maryland Dermatology, Laser, Skin & Vein Institute

Hunt Valley, Maryland, 21030

United States

St. Luke's University Health Network

Bethlehem, Pennsylvania, 18015

United States

Collaborators and Investigators

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

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 Registration Dates

Study Start Date2024-09-21

Study Completion Date2027-04

Study Record Updates

Study Start Date2024-09-21

Study Completion Date2027-04

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Port-wine Birthmarks
Port-Wine Stain
Nevus Flammeus