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NCT05171894 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate Efficacy and Safety of Light Dose in Subjects With PWB Treated With Hemoporfin PDT
A Phase 2 study of Port-Wine Stain and Port-wine Birthmarks, sponsored by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co..
- Recruiting
- Registry status
- Phase 2
- Development phase
- 84
- Enrollment target
- 5
- Study locations
NCT05171894 is a Phase 2 study of Port-Wine Stain and Port-wine Birthmarks that is actively recruiting participants, run by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co.. The registered enrollment target is 84 participants. The trial reports 5 study locations across 4 states.
The verdict
NCT05171894, a Phase 2 study of Port-Wine Stain and Port-wine Birthmarks, is actively recruiting participants, sponsored by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co..
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 84 participants
- Enrollment target
- 5
- Study locations
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 Studied
Interventions
- DRUG Hemopfin+Green Light
- DEVICE Vehicle+Green Light
Study Locations (5)
California
- UCI Health Beckman Laser Institute & Medical Clinic - Irvine
- Dermatology Cosmetic Associates of La Jolla, Inc. d/b/a West Dermatology Research Center - San Diego
Florida
- Miami Dermatology and Laser Institute - Miami
Maryland
- Maryland Dermatology, Laser, Skin & Vein Institute - Hunt Valley
Pennsylvania
- St. Luke's University Health Network - Bethlehem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2024-09-21 |
| Est. Completion | 2027-04 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05171894
The ClinicalTrials.gov registry entry for NCT05171894 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., which has 1 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Port-Wine Stain appearing as the primary indexed condition, and to 2 interventions - of which Hemopfin+Green Light is the first listed.
NCT05171894 reports 5 study locations spanning 4 distinct geographic areas - top geographies include California, Florida, Maryland.
Frequently Asked Questions
What is clinical trial NCT05171894 about?
NCT05171894 is a clinical study titled "A Study to Evaluate Efficacy and Safety of Light Dose in Subjects With PWB Treated With Hemoporfin PDT". 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.
What is the current status of trial NCT05171894?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 84 participants. The study started on 2024-09-21. Estimated completion is 2027-04.
What conditions does trial NCT05171894 study?
This clinical trial studies the following conditions: Port-Wine Stain, Port-wine Birthmarks, Nevus Flammeus.
What interventions are being tested in trial NCT05171894?
The interventions under investigation include: Hemopfin+Green Light (DRUG), Vehicle+Green Light (DEVICE).
Who is sponsoring clinical trial NCT05171894?
This trial is sponsored by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05171894 being conducted?
This trial has 5 study locations across California, Florida, Maryland, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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