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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03948997
Recruitment Status : Active, not recruiting
First Posted : May 14, 2019
Last Update Posted : May 14, 2019
Sponsor:
Collaborators:
Air Force General Hospital of the PLA
First Hospital of China Medical University
Chinese Academy of Medical Sciences
Information provided by (Responsible Party):
xjpfW, Xijing Hospital

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

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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
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : October 1, 2019

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



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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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


Sponsors and Collaborators
xjpfW
Air Force General Hospital of the PLA
First Hospital of China Medical University
Chinese Academy of Medical Sciences
Investigators
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Principal Investigator: Gang Wang, Prof Dermatology Derpartment of Xijing Hospital
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Responsible Party: xjpfW, Head of Dermatology, Xijing Hospital
ClinicalTrials.gov Identifier: NCT03948997    
Other Study ID Numbers: XijingH-PF-20150902
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by xjpfW, Xijing Hospital:
port wine stain, PI3K, vascular malformation,PDL
Additional relevant MeSH terms:
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Hemangioma, Capillary
Port-Wine Stain
Skin Abnormalities
Congenital Abnormalities
Skin Diseases
Hemangioma
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms