The Role of Angiogenesis-related Pathways in the Development of Port Wine Stains
Primary Purpose
Port Wine Stain
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pulsed dye laser (PDL)
Sponsored by
About this trial
This is an interventional basic science trial for Port Wine Stain focused on measuring port wine stain, PI3K, vascular malformation,PDL
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment group
No treatment group
Arm Description
Patients with port wine stains receive PDL (1.5-10ms, 11-12.5J/cm2) with a treatment range of approximately 10*10cm2
Patients with port wine stains have not been treated with PDL treatment
Outcomes
Primary Outcome Measures
Exon mutation sequences and mutation frequencies
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
Changes in the levels of cytokines in serum and skin tissues
Changes in the levels of VEGF, FGF, HGF, PDGF, TGF-beta and other factors in serum and skin tissues before and after laser treatment
Full Information
NCT ID
NCT03948997
First Posted
May 10, 2019
Last Updated
March 10, 2021
Sponsor
xjpfW
Collaborators
Air Force General Hospital of the PLA, First Hospital of China Medical University, Chinese Academy of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03948997
Brief Title
The Role of Angiogenesis-related Pathways in the Development of Port Wine Stains
Official Title
The Role of Angiogenesis-related Pathways in the Development of Refractory Port Wine Stains
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2015 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
xjpfW
Collaborators
Air Force General Hospital of the PLA, First Hospital of China Medical University, Chinese Academy of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Port Wine Stain
Keywords
port wine stain, PI3K, vascular malformation,PDL
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Patients with port wine stains receive PDL (1.5-10ms, 11-12.5J/cm2) with a treatment range of approximately 10*10cm2
Arm Title
No treatment group
Arm Type
No Intervention
Arm Description
Patients with port wine stains have not been treated with PDL treatment
Intervention Type
Radiation
Intervention Name(s)
Pulsed dye laser (PDL)
Intervention Description
Pulsed dye laser (PDL, 595nm) is effective for vasodilatory diseases, especially for the superficial to middle layers of the dermis
Primary Outcome Measure Information:
Title
Exon mutation sequences and mutation frequencies
Description
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.
Time Frame
Baseline (before treatment)
Secondary Outcome Measure Information:
Title
Changes in the levels of cytokines in serum and skin tissues
Description
Changes in the levels of VEGF, FGF, HGF, PDGF, TGF-beta and other factors in serum and skin tissues before and after laser treatment
Time Frame
baseline (before treatment) and 1, 3, 7 days after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gang Wang, Prof
Organizational Affiliation
Dermatology Derpartment of Xijing Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Role of Angiogenesis-related Pathways in the Development of Port Wine Stains
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