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

Primary Purpose

Port-Wine Stain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PDT treatment device
Sponsored by
Gang Ma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Port-Wine Stain focused on measuring pulsed dye laser, photodynamic therapy

Eligibility Criteria

1 Year - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Experimental

    Arm Label

    PDL-treated PWS

    without treatment PWS

    Arm Description

    PWS treated with PDL before will be treated with PDT

    PWS without treatment before will be treated with PDT

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Chromameter evaluation
    Blanching of the PWS lesions was evaluated using a SkinColorCatch" chromameter (Delfin Technologies, Kuopio, Finland).

    Full Information

    First Posted
    August 22, 2020
    Last Updated
    August 29, 2020
    Sponsor
    Gang Ma
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04536740
    Brief Title
    Effect of Pulsed Dye Laser on Photodynamic Therapy of Port-Wine Stains
    Official Title
    Effect of Pulsed Dye Laser on Photodynamic Therapy of Port-Wine Stains: a Single Center, Perspective, Paralled, Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2020 (Anticipated)
    Primary Completion Date
    June 30, 2022 (Anticipated)
    Study Completion Date
    September 30, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Gang Ma

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.
    Detailed Description
    Port-wine stain (PWS) is a congenital capillary malformation characterized by ectatic capillaries and postcapillary venules located predominantly in the papillary and mid-reticular layers of the dermis. It has an incidence of 3-5/1000 newborns and grows commensurately with the affected individual. Pulsed dye laser (PDL) of 585 and 595 nm is considered to be the gold standard for treating PWS. Although PDL treatment can significantly lighten and reduce most PWS lesions, 20% of cases show little improvement after treatment. This ratio therefore represents a relatively large number of patients who may benefit from an alternative treatment modality. Vascular-targeted photodynamic therapy (PDT) has been used to treat PWS since the 1990s. In 1990, Orenstein et al. used a chicken comb model to show that PDT can treat hypervascular dermal lesions while leaving the normal overlying epidermis completely intact. The use of vascular-targeted PDT for treating PWS was first described in 1991. PDT can theoretically target ectatic capillaries of all diameters and, in contrast to PDL, can induce vascular damage deeper in the dermis, with a considerably reduced risk of epidermal necrosis due to its vascular-selective characteristics. Previous studies have also demonstrated that PDT is an effective and safe means of improving the appearance of PWS. Our previous researches suggested that PDT may be a beneficial option for PWS cases that are resistant to multiple PDL treatments.Therefore, the choice of early treatment for PWS is very important . The effect of PDL therapy on the follow-up photodynamic treatment of PWS unknown. 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. Our objectis to explore whether the previous PDL treatment will affect the efficacy of the follow-up PDT on PWS, so as to provide early treatment options for children with PWS.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Port-Wine Stain
    Keywords
    pulsed dye laser, photodynamic therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    68 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PDL-treated PWS
    Arm Type
    Other
    Arm Description
    PWS treated with PDL before will be treated with PDT
    Arm Title
    without treatment PWS
    Arm Type
    Experimental
    Arm Description
    PWS without treatment before will be treated with PDT
    Intervention Type
    Device
    Intervention Name(s)
    PDT treatment device
    Other Intervention Name(s)
    light-emitting diode green-light therapeutic apparatus
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Visual evaluation
    Description
    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
    Time Frame
    Change from Baseline Visual evaluation at 3 months after PDT treatment
    Secondary Outcome Measure Information:
    Title
    Chromameter evaluation
    Description
    Blanching of the PWS lesions was evaluated using a SkinColorCatch" chromameter (Delfin Technologies, Kuopio, Finland).
    Time Frame
    Change from Baseline Chromameter evaluation at 3 months after PDT treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Year
    Maximum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gang Ma
    Phone
    021-23271699
    Ext
    5576
    Email
    docmagang@126.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Qingqing Cen
    Phone
    021-23271699
    Ext
    5576
    Email
    cenqingqing1995@163.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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

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