Port Wine StainsNCT07353385
Enhanced Efficacy Through Optimization of Hemoporfin-Photodynamic Therapy Parameters in Port-Wine Stains
A study testing irradiation at 84 mW/cm² for 17 minutes per spot and irradiation at 75 mW/cm² for 19 minutes per spot in people with Port Wine Stains, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site in China.
Trial summary
1. Background and Objectives Port-wine stain (PWS) is a congenital capillary malformation located in the upper dermis. Hematoporphyrin monomethyl ether (HMME)-mediated photodynamic therapy (PDT) has been established as a primary and effective treatment for PWS in China. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Port Wine Stains
- What is being tested?
- irradiation at 84 mW/cm² for 17 minutes per spot and irradiation at 75 mW/cm² for 19 minutes per spot
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 1 Jun 2025
- Phase
- Interventional
- 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ·Clinical diagnosis of port-wine stain (PWS).
Who cannot join
- concurrent syndromes such as Sturge-Weber or Klippel-Trenaunay syndrome;
- a history of previous radiotherapy, photodynamic therapy, or any other intervention in the treatment area that might confound efficacy evaluation;
- a known diagnosis of cutaneous photosensitivity, porphyria, or hypersensitivity to porphyrin-based drugs;
- administration of photosensitizing medications, including but not limited to griseofulvin, retinoids, thiazide diuretics, sulfonamides, and tetracyclines, within 4 weeks prior to the study.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Xi'an Jiao Tong University
Xi’an, Shanxi, 710004
About this study
Official title: Enhanced Efficacy Through Optimization of Hemoporfin-Photodynamic Therapy Parameters in Port-Wine Stains: A Prospective, Randomized Controlled Study
- Background and Objectives Port-wine stain (PWS) is a congenital capillary malformation located in the upper dermis. Hematoporphyrin monomethyl ether (HMME)-mediated photodynamic therapy (PDT) has been established as a primary and effective treatment for PWS in China. However, treatment parameters, particularly irradiance and irradiation duration, vary widely in clinical practice based on physician experience, with a lack of evidence from controlled trials to guide optimization. The efficacy of PDT relies on a type II photochemical reaction, which is oxygen-dependent. High irradiance may lead to rapid oxygen depletion in the treatment area, potentially limiting therapeutic outcomes. This prospective, randomized controlled trial aims to compare the efficacy and safety of a low-irradiance, prolonged-duration protocol versus a high-irradiance, shorter-duration protocol in HMME-PDT for PWS, while maintaining an identical total light dose.
- Study Design This was a single-center, randomized controlled, single-blind trial. The study protocol was approved by the Ethics Committee of The Second Affiliated Hospital of Xi'an Jiaotong University (Approval No. 2024219). A total of 33 pediatric patients (aged 3-12 years) with facial or neck PWS were enrolled and randomly assigned to one of two groups: Low-Power Group (n=15): Received irradiation at 75 mW/cm² for 19 minutes per spot. High-Power Group (n=18): Received irradiation at 84 mW/cm² for 17 minutes per spot. Both groups received a single session of HMME-PDT with the same total light dose. All patients received an intravenous infusion of Hemoporfin at a dose of 5.0 mg/kg, followed by irradiation with a 532-nm LED green light.
- Primary evaluation indicators
The primary efficacy endpoint was lesion clearance assessed at the 3-month follow-up using three independent methods:
Read more
Blinded Quartile Grading: Performed by two independent dermatologists based on high-resolution photographs.
Quantitative Lesion Area Reduction: The percentage reduction in the PWS area was calculated from VISIA complexion analysis system "redness" images using ImageJ software.
Erythema Index (EI) Analysis: The relative change in the EI (ΔEI%) between the lesion and normal skin was quantified.
- Conditions
- Port Wine Stains
- Being tested
- irradiation at 84 mW/cm² for 17 minutes per spot, irradiation at 75 mW/cm² for 19 minutes per spot
- Medical subject headings
- Hemangioma, Capillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
irradiation at 84 mW/cm² for 17 minutes per spotRadiation
Patients were positioned appropriately, with pediatric patients secured using a restraining bed. The target lesions were fully exposed (shaved if necessary), cleansed, disinfected, and the surrounding healthy skin was shielded with black cloth. The laser parameters and handpiece position were adjusted to ensure the lesion remained within the effective irradiation field.
Under dim light, a prepared Hemoporfin (Shanghai Fudan Zhangjiang Pharmaceutical Co., Ltd.) solution was diluted to 20 mL at a dosage of 5.0 mg/kg and administered via infusion pump at a controlled rate within 5 minutes. Approximately 3 minutes post-initiation of infusion, irradiation with a 532-nm LED green light (Wuhan Yage Optoelectronic Technology Co., Ltd.) commenced. To maintain an identical total light dose between groups, the high-power group received 84 mW/cm² for 17 minutes per spot.
irradiation at 75 mW/cm² for 19 minutes per spotRadiation
Patients were positioned appropriately, with pediatric patients secured using a restraining bed. The target lesions were fully exposed (shaved if necessary), cleansed, disinfected, and the surrounding healthy skin was shielded with black cloth. The laser parameters and handpiece position were adjusted to ensure the lesion remained within the effective irradiation field.
Under dim light, a prepared Hemoporfin (Shanghai Fudan Zhangjiang Pharmaceutical Co., Ltd.) solution was diluted to 20 mL at a dosage of 5.0 mg/kg and administered via infusion pump at a controlled rate within 5 minutes. Approximately 3 minutes post-initiation of infusion, irradiation with a 532-nm LED green light (Wuhan Yage Optoelectronic Technology Co., Ltd.) commenced. To maintain an identical total light dose between groups, the low-power group received 75 mW/cm² for 19 minutes per spot.
| Study group | Role | What they receive |
|---|---|---|
| Low power group | Experimental | Received irradiation at 75 mW/cm² for 19 minutes per spot. Receives: Radiation: irradiation at 75 mW/cm² for 19 minutes per spot |
| High power group | Experimental | Received irradiation at 84 mW/cm² for 17 minutes per spot. Receives: Radiation: irradiation at 84 mW/cm² for 17 minutes per spot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blinded Quartile Grading
Clinical efficacy was assessed by two blinded dermatologists using a quartile grading scale based on high-resolution photographs taken before treatment and at the 3-month follow-up. Therapeutic responses were classified into four grades: an Excellent Response was defined as lesion clearance of 75% or greater; a Good Response represented clearance ranging from 50% to 74%; a Moderate Response indicated clearance between 25% and 49%; and a Poor Response was assigned for clearance of 24% or less.
Measured: from enrollment to 3 months post-treatment
Secondary outcomes (2)
Quantitative Lesion Area Reduction
Objective evaluation was performed by analyzing the VISIA-captured "redness images" with ImageJ software (National Institutes of Health), where the percentage reduction in the lesion area was calculated.
Measured: from enrollment to 3 months post-treatment
Erythema Index (EI) Analysis
The relative change in the EI (ΔEI%) between the lesion and normal skin was quantified. The standardized VISIA images were imported into ImageJ and split into RGB channels. The R (red) and G (green) channels were subsequently converted into logarithmic images. An 'EI image' was generated by subtracting the Log G image from the Log R image using the Image Calculator function. The mean EI values were then measured within both the lesion and an adjacent normal skin area. The differences (ΔEI) were calculated as follows: ΔEIpre = EIlesion(pre) - EInormal(pre); ΔEIpost = EIlesion(post) - EInormal(post). The final improvement percentage was expressed as ΔEI% = (ΔEIpre - ΔEIpost) / ΔEIpre × 100%.
Measured: from enrollment to 3 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Jul 2024
- Primary completion30 Mar 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Port Wine StainsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07353385
- Sponsor's protocol ID
- 2024219
- Status last verified
- Jan 2026
- First submitted
- 30 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Efficacy Through Optimization of Hemoporfin-Photodynamic Therapy Parameters in Port-Wine Stains: A Prospective, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07353385
- Acronym / sponsor ID
- 2024219
- Conditions
- Port Wine Stains
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 20 Jan 2026 (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.
- Background and Objectives Port-wine stain (PWS) is a congenital capillary malformation located in the upper dermis. Hematoporphyrin monomethyl ether (HMME)-mediated photodynamic therapy (PDT) has been established as a primary and effective treatment for PWS in China. However, treatment parameters, particularly irradiance and irradiation duration, vary widely in clinical practice based on physician experience, with a lack of evidence from controlled trials to guide optimization. The efficacy of PDT relies on a type II photochemical reaction, which is oxygen-dependent. High irradiance may lead to rapid oxygen depletion in the treatment area, potentially limiting therapeutic outcomes. This prospective, randomized controlled trial aims to compare the efficacy and safety of a low-irradiance, prolonged-duration protocol versus a high-irradiance, shorter-duration protocol in HMME-PDT for PWS, while maintaining an identical total light dose.
- Study Design This was a single-center, randomized controlled, single-blind trial. The study protocol was approved by the Ethics Committee of The Second Affiliated Hospital of Xi'an Jiaotong University (Approval No. 2024219). A total of 33 pediatric patients (aged 3-12 years) with facial or neck PWS were enrolled and randomly assigned to one of two groups: Low-Power Group (n=15): Received irradiation at 75 mW/cm² for 19 minutes per spot. High-Power Group (n=18): Received irradiation at 84 mW/cm² for 17 minutes per spot. Both groups received a single session of HMME-PDT with the same total light dose. All patients received an intravenous infusion of Hemoporfin at a dose of 5.0 mg/kg, followed by irradiation with a 532-nm LED green light.
- Primary evaluation indicators
The primary efficacy endpoint was lesion clearance assessed at the 3-month follow-up using three independent methods:
Blinded Quartile Grading: Performed by two independent dermatologists based on high-resolution photographs.
Quantitative Lesion Area Reduction: The percentage reduction in the PWS area was calculated from VISIA complexion analysis system "redness" images using ImageJ software.
Erythema Index (EI) Analysis: The relative change in the EI (ΔEI%) between the lesion and normal skin was quantified.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low power group | Experimental | Radiation: irradiation at 75 mW/cm² for 19 minutes per spotReceived irradiation at 75 mW/cm² for 19 minutes per spot. |
| High power group | Experimental | Radiation: irradiation at 84 mW/cm² for 17 minutes per spotReceived irradiation at 84 mW/cm² for 17 minutes per spot. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- ·Clinical diagnosis of port-wine stain (PWS).
Key exclusion criteria (4 listed)
- concurrent syndromes such as Sturge-Weber or Klippel-Trenaunay syndrome;
- a history of previous radiotherapy, photodynamic therapy, or any other intervention in the treatment area that might confound efficacy evaluation;
- a known diagnosis of cutaneous photosensitivity, porphyria, or hypersensitivity to porphyrin-based drugs;
- administration of photosensitizing medications, including but not limited to griseofulvin, retinoids, thiazide diuretics, sulfonamides, and tetracyclines, within 4 weeks prior to the study.
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 |
|---|---|---|
| irradiation at 84 mW/cm² for 17 minutes per spotPatients were positioned appropriately, with pediatric patients secured using a restraining bed. The target lesions were fully exposed (shaved if necessary), cleansed, disinfected, and the surrounding healthy skin was shielded with black cloth. The laser parameters and handpiece position were adjusted to ensure the lesion remained within the effective irradiation field. Under dim light, a prepared Hemoporfin (Shanghai Fudan Zhangjiang Pharmaceutical Co., Ltd.) solution was diluted to 20 mL at a dosage of 5.0 mg/kg and administered via infusion pump at a controlled rate within 5 minutes. Approximately 3 minutes post-initiation of infusion, irradiation with a 532-nm LED green light (Wuhan Yage Optoelectronic Technology Co., Ltd.) commenced. To maintain an identical total light dose between groups, the high-power group received 84 mW/cm² for 17 minutes per spot. | Radiation | High power group |
| irradiation at 75 mW/cm² for 19 minutes per spotPatients were positioned appropriately, with pediatric patients secured using a restraining bed. The target lesions were fully exposed (shaved if necessary), cleansed, disinfected, and the surrounding healthy skin was shielded with black cloth. The laser parameters and handpiece position were adjusted to ensure the lesion remained within the effective irradiation field. Under dim light, a prepared Hemoporfin (Shanghai Fudan Zhangjiang Pharmaceutical Co., Ltd.) solution was diluted to 20 mL at a dosage of 5.0 mg/kg and administered via infusion pump at a controlled rate within 5 minutes. Approximately 3 minutes post-initiation of infusion, irradiation with a 532-nm LED green light (Wuhan Yage Optoelectronic Technology Co., Ltd.) commenced. To maintain an identical total light dose between groups, the low-power group received 75 mW/cm² for 19 minutes per spot. | Radiation | Low power group |
Primary outcome
Blinded Quartile Grading
Time frame: from enrollment to 3 months post-treatment
Clinical efficacy was assessed by two blinded dermatologists using a quartile grading scale based on high-resolution photographs taken before treatment and at the 3-month follow-up. Therapeutic responses were classified into four grades: an Excellent Response was defined as lesion clearance of 75% or greater; a Good Response represented clearance ranging from 50% to 74%; a Moderate Response indicated clearance between 25% and 49%; and a Poor Response was assigned for clearance of 24% or less.
2 secondary outcomes
Quantitative Lesion Area Reduction
Time frame: from enrollment to 3 months post-treatment
Erythema Index (EI) Analysis
Time frame: from enrollment to 3 months post-treatment
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 20 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing irradiation at 84 mW/cm² for 17 minutes per spot and irradiation at 75 mW/cm² for 19 minutes per spot in people with Port Wine Stains, 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 1 inclusion and 4 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 20 Jan 2026. 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?
Blinded Quartile Grading (time frame: from enrollment to 3 months post-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 20 Jan 2026.