Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05171894 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Site details revised at 2 of 5 sitesv8
  2. Primary completion date: Jan 2026 to Jan 2027v7 Show 4 more changesShow less
    • Study sites: 6 to 5
    • Study completion date: Apr 2026 to Apr 2027
    • Eligibility criteria expanded, about 59 words
    • Study description shortened, about 10 words
  3. Start date changed from estimate of Aug 30, 2024 to Sep 21, 2024
    • Interventions: Hemopfin+PDT (Drug), Vehicle+PDT (Device) to Hemopfin+Green Light (Drug), Vehicle+Green Light (Device)
    • Site contacts updated at 6 of 6 sites
    • Study title shortened, about 1 word
    v6
  4. Site contacts updated at 6 of 6 sitesv5
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Aug 31, 2023 to Aug 30, 2024
    • Study sites: 0 to 6
    • Interventions: Hemopfin+PDT (Drug), Vehicle+PDT (Drug) to Hemopfin+PDT (Drug), Vehicle+PDT (Device)
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Primary completion date: Jun 2024 to Jan 2026v3 Show 8 more changesShow less
    • Start date: Dec 30, 2022 to Aug 31, 2023
    • Primary endpoints: 1 to 2
    • Study completion date: Sep 2024 to Apr 2026
    • Interventions: Hemopfin+PDF (Drug), Vehicle+PDF (Drug) to Hemopfin+PDT (Drug), Vehicle+PDT (Drug)
    • Eligibility criteria shortened, about 308 words
    • Secondary endpoints: 12 to 3
    • Study description shortened, about 17 words
    • Study title revised
  2. Start date: Jun 2022 to Dec 30, 2022
    • Secondary endpoints revised (12)
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05171894
Lead Sponsor Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Conditions
(from sponsor)		 Port-wine Birthmarks, Port-Wine Stain, Nevus Flammeus
Related terms Port-Wine Stain
Enrollment 84 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov