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Effect of Pulsed Dye Laser on Photodynamic Therapy of Port-Wine Stains

NCT04536740 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2020-09-03

No results posted yet for this study

Summary

Port-wine stain (PWS) is a congenital capillary malformation with an incidence of 3-5/1000 newborns and grows commensurately with the affected individual.

Although PDL treatment can significantly lighten and reduce most PWS lesions, 20% of cases show little improvement after treatment. Our previous researches suggested that PDT may be a beneficial option for PWS cases that are resistant to multiple PDL treatments.

In this study, a single center, prospective, parallelled, controlled study was conducted to compare the efficacy of PDT on PWS treated with standard PDL and those without any treatment.

Conditions

  • Port-Wine Stain

Interventions

DEVICE

PDT treatment device

All patients will be treated under general anesthesia. After carefully covering the normal skin, hematoporphyrin monomethyl ether (HMME; Shanghai Fudan-Zhangjiang Bio-Pharmaceutical, Shanghai, China) was i.v. transfused at a dose of 5 mg/kg for 20 min at a constant rate. Five to 10 min after the onset of HMME transfusion, continuous irradiation at 532 nm (532-nm light-emitting diode green-light therapeutic apparatus; Wuhan Yage Optic and Electronic Technique, Wuhan, China) was applied with a power density of 80- 95 mW/cm2 for 20-30 min. Concomitant forced air cooling was applied during irradiation for epidermal protection. Post-treatment skin cooling was performed by intermittent application of ice packs over a 3-day period, to minimize pain and potential thermal damage. To prevent the effects of photosensitivity, patients were instructed to avoid exposure to strong light for at least 14 days after treatment.

Sponsors & Collaborators

  • Gang Ma

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2022-06-30
Completion
2022-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04536740 on ClinicalTrials.gov