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

NCT ID: NCT03948997

Last Updated: 2021-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-01
• Study Completion Date: 2019-12-01

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.

Conditions

Port Wine Stain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Treatment group

Patients with port wine stains receive PDL (1.5-10ms, 11-12.5J/cm2) with a treatment range of approximately 10\*10cm2

Group Type: EXPERIMENTAL

Pulsed dye laser (PDL)

Intervention Type: RADIATION

Pulsed dye laser (PDL, 595nm) is effective for vasodilatory diseases, especially for the superficial to middle layers of the dermis

No treatment group

Patients with port wine stains have not been treated with PDL treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pulsed dye laser (PDL)

Pulsed dye laser (PDL, 595nm) is effective for vasodilatory diseases, especially for the superficial to middle layers of the dermis

Intervention Type: RADIATION

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Air Force General Hospital of the PLA

OTHER_GOV

Sponsor Role: collaborator

First Hospital of China Medical University

OTHER

Sponsor Role: collaborator

Chinese Academy of Medical Sciences

OTHER

Sponsor Role: collaborator

xjpfW

OTHER

Sponsor Role: lead

Responsible Party

xjpfW

Head of Dermatology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gang Wang, Prof

Role: PRINCIPAL_INVESTIGATOR

Dermatology Derpartment of Xijing Hospital

Other Identifiers

XijingH-PF-20150902

Identifier Type: -

Identifier Source: org_study_id