Port-Wine StainNCT06875492
Retrospective Cohort Study on the Impact of PDL Treatment History on the Efficacy of HMME-PDT in Treating PWS Children
An observational study of Port-Wine Stain, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site in China.
Trial summary
This retrospective study investigated the influence of prior pulse dye laser (PDL) treatment on the effectiveness of Hemoporfin-PDT in young children aged 1-3 years with PWS. The study population included patients without a history of PDL treatment and patients with a history of PDL treatment. Read more about this study
- Who is it for?
- Ages 1 year to 3 years
- Conditions the study is for
- Port-Wine Stain
- What is being tested?
- HMME-PDT and PDL
- Type of treatment
- Medical device
- How many people
- 273 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 1 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 3 years
- All sexes
- No healthy volunteers
- Child
Study population: This cohort study is a retrospective, single-center study based on a database established by the photodynamic therapy team at the Second Affiliated Hospital of Xi'an Jiaotong University.We defined "young children" as children aged 1 to 3 years. This research encompassed young children who had undergone two or more sessions of Hemoporfin-PDT. Data on gender, age, medical history, type of PWS, lesion location, and post-treatment efficacy were collected following two rounds of Hemoporfin-PDT.
Who may be able to join
- Patients clinically diagnosed with PWS (Port Wine Stain) who were between 1 and 3 years old at the time of their first HMME-PDT treatment.
- Patients who, after evaluation by a clinician, are deemed eligible for HMME-PDT treatment and whose guardians have signed an informed consent form.
- Patients who have undergone two or more HMME-PDT treatments.
- ④ Patients with complete basic information and treatment-related information.
Who cannot join
- Exclusion of patients with a history of treatments for PWS other than PDL treatment.
- Patients with other vascular malformations. ④ Exclusion of patients who have received any other PWS treatment within 2 months prior to HMME-PDT treatment.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710004
About this study
This retrospective study investigated the influence of prior pulse dye laser (PDL) treatment on the effectiveness of Hemoporfin-PDT in young children aged 1-3 years with PWS.
The study population included patients without a history of PDL treatment and patients with a history of PDL treatment.
Read the detailed description
Background Hemoporfin-mediated photodynamic therapy (Hemoporfin-PDT) is considered a safe and effective treatment for port-wine stains (PWS). This study aims to investigate the influence of prior pulse dye laser (PDL) treatments history on the effectiveness of Hemoporfin-PDT in young children aged 1-3 years with PWS.
Methods Data was gathered for individuals with PWS aged 1-3 years who received two or more Hemoporfin-PDT treatments. The study population was stratified into two groups: Cohort 1 (No PDL) comprised patients without a history of PDL treatment, while Cohort 2 (Prior PDL) consisted of patients with a history of PDL treatment. An analysis was conducted to investigate the relationship between treatment efficacy and variables including gender, age, location, and type of PWS.
- Conditions
- Port-Wine Stain
- Being tested
- HMME-PDT, PDL
- Keywords
- Pulse dye laser, Hemoporfin-PDT
- Medical subject headings
- Port-Wine Stain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMME-PDTCombination product
Twice HMME-PDT, and the treatment interval is 2 to 3 months.
PDLDevice
Prior PDL treatment history.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (No PDL) | Cohort 1 (No PDL) comprised patients without a history of PDL treatment Receives: Combination Product: HMME-PDT | |
| Cohort 2 (Prior PDL) | Cohort 2 (Prior PDL) consisted of patients with a history of PDL treatment Receives: Combination Product: HMME-PDT; Device: PDL |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of lesions regression
Two independent blinded assessors assessed treatment efficacy by comparing before and after treatment photos of patients receiving Hemoporfin-PDT for reducing redness. The final outcome was determined as the average of these two assessments. Efficacy was assessed using standard quartiles: Excellent (76-100 %); Good (51-75 %); Fair (26-50 %); Poor (0-25 %).
Measured: The efficacy evaluation will be conducted 3 months after the completion of the 2nd HMME-PDT treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start1 Apr 2024
- Primary completion20 Aug 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Port-Wine StainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weihui Zeng, Second Affiliated Hospital of Xi'an Jiaotong University
- Investigators
- Weihui Zeng, Study chair, Second Affiliated Hospital of Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06875492
- Sponsor's protocol ID
- 2024218
- Status last verified
- Mar 2025
- First submitted
- 9 Mar 2025
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Cohort Study on the Impact of PDL Treatment History on the Efficacy of HMME-PDT in Treating PWS Children
- ClinicalTrials.gov ID
- NCT06875492
- Acronym / sponsor ID
- 2024218
- Conditions
- Port-Wine Stain
- Keywords
- Pulse dye laser, Hemoporfin-PDT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This retrospective study investigated the influence of prior pulse dye laser (PDL) treatment on the effectiveness of Hemoporfin-PDT in young children aged 1-3 years with PWS.
The study population included patients without a history of PDL treatment and patients with a history of PDL treatment.
Detailed description
Background Hemoporfin-mediated photodynamic therapy (Hemoporfin-PDT) is considered a safe and effective treatment for port-wine stains (PWS). This study aims to investigate the influence of prior pulse dye laser (PDL) treatments history on the effectiveness of Hemoporfin-PDT in young children aged 1-3 years with PWS.
Methods Data was gathered for individuals with PWS aged 1-3 years who received two or more Hemoporfin-PDT treatments. The study population was stratified into two groups: Cohort 1 (No PDL) comprised patients without a history of PDL treatment, while Cohort 2 (Prior PDL) consisted of patients with a history of PDL treatment. An analysis was conducted to investigate the relationship between treatment efficacy and variables including gender, age, location, and type of PWS.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (No PDL) | – | Combination Product: HMME-PDTCohort 1 (No PDL) comprised patients without a history of PDL treatment |
| Cohort 2 (Prior PDL) | – | Combination Product: HMME-PDT, Device: PDLCohort 2 (Prior PDL) consisted of patients with a history of PDL treatment |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This cohort study is a retrospective, single-center study based on a database established by the photodynamic therapy team at the Second Affiliated Hospital of Xi'an Jiaotong University.We defined "young children" as children aged 1 to 3 years. This research encompassed young children who had undergone two or more sessions of Hemoporfin-PDT. Data on gender, age, medical history, type of PWS, lesion location, and post-treatment efficacy were collected following two rounds of Hemoporfin-PDT.
Key inclusion criteria (4 listed)
- Patients clinically diagnosed with PWS (Port Wine Stain) who were between 1 and 3 years old at the time of their first HMME-PDT treatment.
- ④ Patients with complete basic information and treatment-related information.
Key exclusion criteria (2 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HMME-PDTTwice HMME-PDT, and the treatment interval is 2 to 3 months. | Combination product | Cohort 1 (No PDL), Cohort 2 (Prior PDL) |
| PDLPrior PDL treatment history. | Device | Cohort 2 (Prior PDL) |
Primary outcome
The rate of lesions regression
Time frame: The efficacy evaluation will be conducted 3 months after the completion of the 2nd HMME-PDT treatment.
Two independent blinded assessors assessed treatment efficacy by comparing before and after treatment photos of patients receiving Hemoporfin-PDT for reducing redness. The final outcome was determined as the average of these two assessments. Efficacy was assessed using standard quartiles: Excellent (76-100 %); Good (51-75 %); Fair (26-50 %); Poor (0-25 %).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weihui Zeng study chair
Second Affiliated Hospital of Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Port-Wine Stain, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of lesions regression (time frame: The efficacy evaluation will be conducted 3 months after the completion of the 2nd HMME-PDT treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.