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

NCT04536740 | Unknown

• 1 other identifier: SH9H-2020-T290-1
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

pulsed dye laser; photodynamic therapy

Outcome Measures

Primary Outcomes (1)

• Visual evaluation

  Standard digital photographs were obtained using consistent camera settings (EOS 80D; Canon, Tokyo, Japan), light conditions and patient positions. Three independent, blinded assessors qualitatively assessed color blanching

  Change from Baseline Visual evaluation at 3 months after PDT treatment

Secondary Outcomes (1)

• Chromameter evaluation

  Change from Baseline Chromameter evaluation at 3 months after PDT treatment

Study Arms (2)

PDL-treated PWS

OTHER

PWS treated with PDL before will be treated with PDT

Device: PDT treatment device

without treatment PWS

EXPERIMENTAL

PWS without treatment before will be treated with PDT

Device: PDT treatment device

Interventions

PDT treatment device 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.

Also known as: light-emitting diode green-light therapeutic apparatus

PDL-treated PWS; without treatment PWS

Eligibility Criteria

• Age: 1 Year - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients aged 1-14 years who met the criteria for diagnosis of port-wine stain in The International Society for the Study of Vascular Anomalies（ISSVA);
• Patients in the untreated group had never received any treatment;
• Patients in the PDL-treated group received at least five 595 nm pulse dye laser (PDL) treatment (Vbeam laser; candela Corp., Boston, MA), The time interval between
• Photodynamic therapy and the last pulse dye laser treatment was at least 3 months;
• There were complete medical records, standard photos and test records before and after treatment;
• After fully understanding the treatment plan and risks, patients voluntarily signed the informed consent and was willing to accept clinical trials and cooperate with follow-up.

You may not qualify if:

• Original infection, eczema, ulcers in the lesion site; The patient has a history of seizures in the last six months or the condition is not under control;
• Hypersensitivity to porphyrins, hypersensitivity constitution;
• Scar constitution;
• A history of heavily UV exposure in the last 3 months;
• With abnormal electrocardiogram, heart disease, liver damage, pregnancy or other underlying diseases that may affect treatment;
• Patients are participating in other clinical trials.

Sponsors & Collaborators

• Gang Ma: lead

MeSH Terms

Conditions

Port-Wine Stain

Condition Hierarchy (Ancestors)

Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Gang Ma

CONTACT

021-23271699; docmagang@126.com

Qingqing Cen

CONTACT

021-23271699; cenqingqing1995@163.com

Study Design

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

Study Record Dates

• First Submitted: August 22, 2020
• First Posted: September 3, 2020
• Study Start: October 1, 2020
• Primary Completion: June 30, 2022
• Study Completion: September 30, 2022
• Last Updated: September 3, 2020

Record last verified: 2020-08