WithdrawnInterventionalPhase 1Updated Oct 20, 2022
The Role of Angiogenesis-related Pathways in the Development of Port Wine Stains | NCT03948997 | Trialant
CompletedInterventionalNot ApplicableUpdated Mar 11, 2021
The Role of Angiogenesis-related Pathways in the Development of Port Wine Stains
The Role of Angiogenesis-related Pathways in the Development of Refractory Port Wine Stains
ClinicalTrials.gov ID
NCT03948997
Lead Sponsor
xjpfWOTHER
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
80Estimated
Last Update Posted
Mar 11, 2021Actual
Start Date
Oct 1, 2015Actual
Primary Completion Date
Oct 1, 2019Actual
Completion Date
Dec 1, 2019Actual
Official Title
The Role of Angiogenesis-related Pathways in the Development of Refractory Port Wine Stains
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.
Port Wine Stain
Pulsed dye laser (PDL)
Ages Eligible for Study
Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
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