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出境医 / 临床实验 / The Role of Angiogenesis-related Pathways in the Development of Port Wine Stains

The Role of Angiogenesis-related Pathways in the Development of Port Wine Stains

Study Description
Brief Summary:
  1. Port wine stain (PWS) is a congenital, progressive vascular malformation of human skin involving the superficial vascular plexus that occurs in estimated 3-5 children per 1,000 live births. In childhood, PWS are flat red macules, but lesions tend to darken progressively to purple and, by middle age, often become raised as a result of the development of vascular nodules. Because most malformations occur on the face, PWS is a clinically significant problem in the majority of patients.
  2. The late-stage cobblestoning appearance of PWS subjects is comprised by not only pronounced vascular ectasia with proliferation of thin and/or thick-walled vessels and their stroma, but also numerous epithelial, neural and mesenchymal hamartomatous abnormalities. Despite these histologic observations, the specific mechanisms involved in PWS nodular formation remains unclear.
  3. In one nodular PWS subject, we found that phosphatidylinositol 3-kinases (PI3K)/protein kinase B (AKT) and phosphoinositide phospholipase C g subunit (PLC-g) were activated in both hypertrophic areas and nodules within the lesion. These observations led us to hypothesize that the PI3K pathway may play an important role in nodular formation.

Condition or disease Intervention/treatment Phase
Port Wine Stain Radiation: Pulsed dye laser (PDL) Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: The Role of Angiogenesis-related Pathways in the Development of Refractory Port Wine Stains
Actual Study Start Date : October 1, 2015
Actual Primary Completion Date : October 1, 2019
Actual Study Completion Date : December 1, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: Treatment group
Patients with port wine stains receive PDL (1.5-10ms, 11-12.5J/cm2) with a treatment range of approximately 10*10cm2
 Radiation: Pulsed dye laser (PDL)
Pulsed dye laser (PDL, 595nm) is effective for vasodilatory diseases, especially for the superficial to middle layers of the dermis
No Intervention: No treatment group
Patients with port wine stains have not been treated with PDL treatment
Outcome Measures
Primary Outcome Measures :
  1. Exon mutation sequences and mutation frequencies [ Time Frame: Baseline (before treatment) ]
    In patients with nodular port wine stains, the exon mutation sequence and mutation frequency were compared between normal skin tissue (or blood), erythema and nodular tissue of the same patient.


Secondary Outcome Measures :
  1. Changes in the levels of cytokines in serum and skin tissues [ Time Frame: baseline (before treatment) and 1, 3, 7 days after treatment ]
    Changes in the levels of VEGF, FGF, HGF, PDGF, TGF-beta and other factors in serum and skin tissues before and after laser treatment


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   1 Month to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 1 month - 70 years old, male or female;
  • The patient and the family of the child agreed to participate in the experiment and signed an informed consent form;
  • Clinical diagnosis of refractory port wine stains with thickened nodular or PDL resistance; .There is no bleeding, ulceration, infection, etc. affecting the visual field of laser surgery operation.

Exclusion Criteria:

  • Patients with severe infectious diseases;
  • Heart disease patients;
  • Epilepsy patient;
  • Pregnant patient;
  • Researchers believe that patients who are not suitable for this experiment
Contacts and Locations

Sponsors and Collaborators
xjpfW
Air Force General Hospital of the PLA
First Hospital of China Medical University
Chinese Academy of Medical Sciences
Investigators
Layout table for investigator information
Principal Investigator: Gang Wang, Prof Dermatology Derpartment of Xijing Hospital
Tracking Information
First Submitted Date  ICMJE May 10, 2019
First Posted Date  ICMJE May 14, 2019
Last Update Posted Date March 11, 2021
Actual Study Start Date  ICMJE October 1, 2015
Actual Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2019) 		Exon mutation sequences and mutation frequencies [ Time Frame: Baseline (before treatment) ]
In patients with nodular port wine stains, the exon mutation sequence and mutation frequency were compared between normal skin tissue (or blood), erythema and nodular tissue of the same patient.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2019) 		Changes in the levels of cytokines in serum and skin tissues [ Time Frame: baseline (before treatment) and 1, 3, 7 days after treatment ]
Changes in the levels of VEGF, FGF, HGF, PDGF, TGF-beta and other factors in serum and skin tissues before and after laser treatment
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Role of Angiogenesis-related Pathways in the Development of Port Wine Stains
Official Title  ICMJE The Role of Angiogenesis-related Pathways in the Development of Refractory Port Wine Stains
Brief Summary
  1. Port wine stain (PWS) is a congenital, progressive vascular malformation of human skin involving the superficial vascular plexus that occurs in estimated 3-5 children per 1,000 live births. In childhood, PWS are flat red macules, but lesions tend to darken progressively to purple and, by middle age, often become raised as a result of the development of vascular nodules. Because most malformations occur on the face, PWS is a clinically significant problem in the majority of patients.
  2. The late-stage cobblestoning appearance of PWS subjects is comprised by not only pronounced vascular ectasia with proliferation of thin and/or thick-walled vessels and their stroma, but also numerous epithelial, neural and mesenchymal hamartomatous abnormalities. Despite these histologic observations, the specific mechanisms involved in PWS nodular formation remains unclear.
  3. In one nodular PWS subject, we found that phosphatidylinositol 3-kinases (PI3K)/protein kinase B (AKT) and phosphoinositide phospholipase C g subunit (PLC-g) were activated in both hypertrophic areas and nodules within the lesion. These observations led us to hypothesize that the PI3K pathway may play an important role in nodular formation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Port Wine Stain
Intervention  ICMJE Radiation: Pulsed dye laser (PDL)
Pulsed dye laser (PDL, 595nm) is effective for vasodilatory diseases, especially for the superficial to middle layers of the dermis
Study Arms  ICMJE
  • Experimental: Treatment group
    Patients with port wine stains receive PDL (1.5-10ms, 11-12.5J/cm2) with a treatment range of approximately 10*10cm2
    Intervention: Radiation: Pulsed dye laser (PDL)
  • No Intervention: No treatment group
    Patients with port wine stains have not been treated with PDL treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: May 13, 2019) 		80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 1, 2019
Actual Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 1 month - 70 years old, male or female;
  • The patient and the family of the child agreed to participate in the experiment and signed an informed consent form;
  • Clinical diagnosis of refractory port wine stains with thickened nodular or PDL resistance; .There is no bleeding, ulceration, infection, etc. affecting the visual field of laser surgery operation.

Exclusion Criteria:

  • Patients with severe infectious diseases;
  • Heart disease patients;
  • Epilepsy patient;
  • Pregnant patient;
  • Researchers believe that patients who are not suitable for this experiment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Month to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03948997
Other Study ID Numbers  ICMJE XijingH-PF-20150902
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party xjpfW, Xijing Hospital
Study Sponsor  ICMJE xjpfW
Collaborators  ICMJE
  • Air Force General Hospital of the PLA
  • First Hospital of China Medical University
  • Chinese Academy of Medical Sciences
Investigators  ICMJE
Principal Investigator: Gang Wang, Prof Dermatology Derpartment of Xijing Hospital
PRS Account Xijing Hospital
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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