The Role of Angiogenesis-related Pathways in the Development of Port Wine Stains
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|ClinicalTrials.gov Identifier: NCT03948997|
Recruitment Status : Active, not recruiting
First Posted : May 14, 2019
Last Update Posted : May 14, 2019
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Port Wine Stain||Radiation: Pulsed dye laser (PDL)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|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|
|Estimated Primary Completion Date :||October 1, 2019|
|Estimated Study Completion Date :||October 1, 2019|
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
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03948997
|Principal Investigator:||Gang Wang, Prof||Dermatology Derpartment of Xijing Hospital|