A Study to Evaluate Efficacy and Safety of Light Dose in Subjects With PWB Treated With Hemoporfin PDT
NCT ID: NCT05171894
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
84 participants
INTERVENTIONAL
2024-09-21
2027-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Hemopfin+Green Light
All qualified subjects randomized to Hemoporfin PDT treatment to receive up to 3 cycles of treatment.
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.
Hemopfin+Green Light
All qualified subjects randomized to Hemoporfin PDT treatment to receive up to 3 cycles of treatment.
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.
Hemopfin+Green Light
All qualified subjects randomized to Hemoporfin PDT treatment to receive up to 3 cycles of treatment.
Placebo+A J/cm2 Green Light
Participants will receive Vehicle (Saline) via intravenous (IV) infusion and fixed laser irradiation for certain time.
Vehicle+Green Light
All qualified subjects randomized to vehicle PDT treatment to receive up to 3 cycles of treatment.
Placebo+B J/cm2 Green Light
Participants will receive Vehicle (Saline) via intravenous (IV) infusion and fixed laser irradiation for certain time.
Vehicle+Green Light
All qualified subjects randomized to vehicle PDT treatment to receive up to 3 cycles of treatment.
Placebo+C J/cm2 Green Light
Participants will receive Vehicle (Saline) via intravenous (IV) infusion and fixed laser irradiation for certain time.
Vehicle+Green Light
All qualified subjects randomized to vehicle PDT treatment to receive up to 3 cycles of treatment.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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UCI Health Beckman Laser Institute & Medical Clinic
Irvine, California, United States
Dermatology Cosmetic Associates of La Jolla, Inc. d/b/a West Dermatology Research Center
San Diego, California, United States
Miami Dermatology and Laser Institute
Miami, Florida, United States
Maryland Dermatology, Laser, Skin & Vein Institute
Hunt Valley, Maryland, United States
St. Luke's University Health Network
Bethlehem, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Kristen M. Kelly
Role: primary
Marcos Hurtado
Role: backup
Sabrina G. Fabi
Role: primary
Kennedi Stewart
Role: backup
Jill S. Waibel
Role: primary
Peter Illes
Role: backup
Robert A. Weiss
Role: primary
Cristi L. Myers
Role: backup
Andrew C. Krakowski
Role: primary
Jasdip Kaur
Role: backup
Other Identifiers
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F0026-US201
Identifier Type: -
Identifier Source: org_study_id