Trials Sponsors Conditions Drugs Pricing

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 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.

High power group

irradiation at 75 mW/cm² for 19 minutes per spot

Eligibility Criteria

Age3 Years - 12 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

Sponsors & Collaborators

Second Affiliated Hospital of Xi'an Jiaotong University
Otherlead

Study Sites (1)

The Second Affiliated Hospital of Xi'an Jiao Tong University

Xi’an, Shanxi, 710004, China

MeSH Terms

Conditions

Hemangioma, Capillary

Condition Hierarchy (Ancestors)

HemangiomaNeoplasms, Vascular TissueNeoplasms by Histologic TypeNeoplasms

Enrollment

33 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Low power group

High power group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Low power group

High power group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Source record

Locations