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CompletedNCT03948997Updated Mar 11, 2021

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

An interventional study of Pulsed dye laser (PDL) in Port Wine Stain, sponsored by xjpfW. Completed. Open to participants aged 1 Month to 70 Years. Per ClinicalTrials.gov, last updated 2021-03-11.

Sponsored by xjpfW · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 3 years 7 months after the study started (first participant enrolled Oct 2015, registered May 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
1 Month to 70 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Port Wine Stain

Keywords

  • port wine stain, PI3K, vascular malformation,PDL
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In context

Hemangioma, Capillary

83 studies on the registry are indexed under Hemangioma, Capillary; 8 are open to participants now.

This study's planned enrollment of 80 is above the median of 33 across 56 interventional studies indexed under Hemangioma, Capillary.

Browse Hemangioma, Capillary studies →

Lead sponsor

xjpfW is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
80 participants (estimated)

Study arms

  • 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)

  • No intervention
    No treatment group

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

Interventions

  • RadiationPulsed dye laser (PDL)

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline (before treatment)

Secondary outcomes

  1. 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

    Time frame: baseline (before treatment) and 1, 3, 7 days after treatment

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03948997
Lead sponsor
xjpfW
Collaborators
Air Force General Hospital of the PLA, First Hospital of China Medical University, Chinese Academy of Medical Sciences
Responsible party
xjpfW (Head of Dermatology, Xijing Hospital) — Sponsor-investigator
First posted
May 14, 2019
Start date
Oct 1, 2015
Primary completion
Oct 1, 2019
Completion
Dec 1, 2019
Last update
Mar 11, 2021

Study contacts

Gang Wang, Prof
principal investigator · Dermatology Derpartment of Xijing Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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