Trial · NCT05171894
A Study to Evaluate Efficacy and Safety of Light Dose in Subjects With PWB Treated With Hemoporfin PDT
NCT05171894, Phase 2, Recruiting, Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate Efficacy and Safety of Light Dose in Subjects With PWB Treated With Hemoporfin PDT. Trials, record NCT05171894. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05171894
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Efficacy and Safety of Light Dose in Subjects With PWB Treated With Hemoporfin PDT
- NCT number
- NCT05171894
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 84 participants, estimated
- Lead sponsor
- Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
- Conditions
- Port-wine Birthmarks, Port-Wine Stain, Nevus Flammeus
- Interventions
- Hemopfin+Green Light, Vehicle+Green Light
- First posted
- 2021-12-29
- Last updated
- 2026-03-03
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Stage One：Incidence of any local and systemic adverse events. | From baseline until end of study, up to approximately 44 weeks | To compare the efficacy of multiple light doses (fluence) of Hemoporfin PDT To investigate the safety of multiple light doses (fluence) of Hemoporfin/vehicle PDT in subjects with Port-wine birthmark (PWB) in the extremities, trunk, caudal cervical, and/or retroauricular area |
| Primary | Stage Two: Port Wine Birthmark-Investigator Global Assessment (PWB-IGA) scale score reduction. | From baseline until end of study, up to approximately 44 weeks | To compare the efficacy of multiple light doses (fluence) of Hemoporfin PDT with vehicle PDT in subjects with PWB of face and/or neck. |
| Secondary | Stage One：Change from Baseline in overall PWB-IGA severity score and other scales. | From baseline until end of study, up to approximately 44 weeks | To further evaluate the efficacy of multiple light doses (fluence) of Hemoporfin/vehicle PDT in subjects with PWB. |
| Secondary | Stage Two: Change from Baseline in overall PWB-IGA severity score and other scales. | From baseline until end of study, up to approximately 44 weeks | To further evaluate the efficacy of multiple light doses (fluence) of Hemoporfin/vehicle PDT in subjects with PWB. |
| Secondary | Stage Two: Incidence of any local and systemic adverse events. | From baseline until end of study, up to approximately 44 weeks | To investigate the safety of multiple light doses (fluence) of Hemoporfin/vehicle PDT in subjects with Port-wine birthmark (PWB) |
| Other | Stage One：Maximum observed plasma concentration (Cmax) of Hemoporfin | On the first day of the Cycle 1 (each cycle is 56 days) | To check what time will it take to reach the maximum contraction of Hemoporfin |
| Other | Stage One：Area under the concentration-time curve (AUC 0-∞) from time 0 to infinity of Hemoporfin | On the first day of the Cycle 1 (each cycle is 56 days) | To check the drug profile for absorption, distribution, metabolism and excretion for Hemoporfin |
| Other | Stage One：Terminal elimination half-life (t1/2) of Hemoporfin | On the first day of the Cycle 1 (each cycle is 56 days) | To check how much time Hemoporfin will take to eliminate half of it's concentration from participants. |
| Other | Stage One：Time to Cmax (Tmax) of Hemoporfin | On the first day of the Cycle 1 (each cycle is 56 days) | To check what will be the maximum concentration participants will obtained of Hemoporfin |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05171894
GET https://conductscience.org/api/trials/v1/NCT05171894/registered