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

Part of paid clinical trials in Irvine, California.

Sponsor
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Study ID
NCT05171894
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Nevus Flammeus
  • Port-Wine Stain
  • Port-wine Birthmarks

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Hemopfin+Green Light — DRUG
    All qualified subjects randomized to Hemoporfin PDT treatment to receive up to 3 cycles of treatment.
  • Vehicle+Green Light — DEVICE
    All qualified subjects randomized to vehicle PDT treatment to receive up to 3 cycles of treatment.

Study Details

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.

Key Dates

Start date
Sep 21, 2024
Status verified
Nov 2025
Primary completion
Jan 31, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
84 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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 ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
UCI Health Beckman Laser Institute & Medical ClinicIrvineCalifornia92697
Kristen M. Kelly
[email protected]
949-824-7103
Marcos Hurtado
[email protected]
949-824-7103
Kristen M. Kelly (PRINCIPAL_INVESTIGATOR)
Dermatology Cosmetic Associates of La Jolla, Inc. d/b/a West Dermatology Research CenterSan DiegoCalifornia92121
Sabrina G. Fabi
[email protected]
858-657-1004
Kennedi Stewart
[email protected]
858-657-1004
Sabrina G. Fabi (PRINCIPAL_INVESTIGATOR)
Miami Dermatology and Laser InstituteMiamiFlorida33173
Jill S. Waibel
[email protected]
(561) 313-1457
Peter Illes
[email protected]
305-279-6060
Jill S. Waibel (PRINCIPAL_INVESTIGATOR)
Maryland Dermatology, Laser, Skin & Vein InstituteHunt ValleyMaryland21030
Robert A. Weiss
[email protected]
410-666-3960
Cristi L. Myers
[email protected]
410-666-2839
Robert A. Weiss (PRINCIPAL_INVESTIGATOR)
St. Luke's University Health NetworkBethlehemPennsylvania18015
Andrew C. Krakowski
[email protected]
484-503-7546
Jasdip Kaur
[email protected]
484-658-1828
Andrew C. Krakowski (PRINCIPAL_INVESTIGATOR)

Find similar trials in Irvine, CA

By research site
UCI Health Beckman Laser Institute & Medical Clinic· Irvine, CADermatology Cosmetic Associates of La Jolla, Inc. d/b/a West Dermatology Research Center· San Diego, CAMiami Dermatology and Laser Institute· Miami, FLMaryland Dermatology, Laser, Skin & Vein Institute· Hunt Valley, MDSt. Luke's University Health Network· Bethlehem, PA

Related Studies