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NCT Number: NCT07353385

Enhanced Efficacy Through Optimization of Hemoporfin-Photodynamic Therapy Parameters in Port-Wine Stains

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. 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. 2. 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. 3. 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.

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Key information

Conditions

Port Wine Stains Hemangioma Hemangioma, Capillary Neoplasms Neoplasms by Histologic Type Neoplasms, Vascular Tissue

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Xi'an Jiao Tong University

Xi’an, Shanxi, 710004, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

·Clinical diagnosis of port-wine stain (PWS).

Exclusion criteria

  • 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.

Treatment and study plan

irradiation at 84 mW/cm² for 17 minutes per spot

Radiation

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 spot

Radiation

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Quantitative Lesion Area Reduction

    Time frame: from enrollment to 3 months post-treatment

    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.

  2. Erythema Index (EI) Analysis

    Time frame: from enrollment to 3 months post-treatment

    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%.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Xi'an Jiaotong University

Other

Registry information

Official study title

Enhanced Efficacy Through Optimization of Hemoporfin-Photodynamic Therapy Parameters in Port-Wine Stains: A Prospective, Randomized Controlled Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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