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

NCT05171894 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2026-03-03

No results posted yet for this study

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

Interventions

DRUG

Hemopfin+Green Light

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

DEVICE

Vehicle+Green Light

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

Sponsors & Collaborators

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

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-21
Primary Completion
2027-01-31
Completion
2027-04-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05171894 on ClinicalTrials.gov