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

NCT07353385 | Completed

• 1 other identifier: 2024219
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.Study Design
3. 3.Primary evaluation indicators

Conditions

Port Wine Stains

Outcome Measures

Primary Outcomes (1)

• 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.

  from enrollment to 3 months post-treatment

Secondary Outcomes (2)

• Quantitative Lesion Area Reduction

  from enrollment to 3 months post-treatment

• Erythema Index (EI) Analysis

  from enrollment to 3 months post-treatment

Study Arms (2)

Low power group

EXPERIMENTAL

Received irradiation at 75 mW/cm² for 19 minutes per spot.

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.

Radiation: irradiation at 84 mW/cm² for 17 minutes per spot

Interventions

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.

High power group

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.

Low power group

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Xi'an Jiaotong University: lead

Study Sites (1)

The Second Affiliated Hospital of Xi'an Jiao Tong University

Xi’an, Shanxi, 710004, China

Location

MeSH Terms

Conditions

Hemangioma, Capillary

Condition Hierarchy (Ancestors)

Hemangioma; Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 20, 2026
• Study Start: July 1, 2024
• Primary Completion: March 30, 2025
• Study Completion: June 1, 2025
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

CN (1)