Port Wine StainNCT03948997
The Role of Angiogenesis-related Pathways in the Development of Port Wine Stains
A study testing Pulsed dye laser (PDL) in people with Port Wine Stain, run by xjpfW.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 70 years
- Conditions the study is for
- Port Wine Stain
- What is being tested?
- Pulsed dye laser (PDL)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2015to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with severe infectious diseases;
- Heart disease patients;
- Epilepsy patient;
- Pregnant patient;
- Researchers believe that patients who are not suitable for this experiment
About this study
Official title: The Role of Angiogenesis-related Pathways in the Development of Refractory Port Wine Stains
- 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.
- Conditions
- Port Wine Stain
- Being tested
- Pulsed dye laser (PDL)
- Keywords
- port wine stain, PI3K, vascular malformation,PDL
- Medical subject headings
- Port-Wine Stain, Hereditary Sensory and Autonomic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed dye laser (PDL)Radiation
Pulsed dye laser (PDL, 595nm) is effective for vasodilatory diseases, especially for the superficial to middle layers of the dermis
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Patients with port wine stains receive PDL (1.5-10ms, 11-12.5J/cm2) with a treatment range of approximately 10*10cm2 Receives: Radiation: Pulsed dye laser (PDL) |
| No treatment group | No intervention | Patients with port wine stains have not been treated with PDL treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: baseline (before treatment) and 1, 3, 7 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start1 Oct 2015
- Primary completion1 Oct 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Port Wine StainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- xjpfW
- Sponsor type
- University, hospital or other
- Collaborators
- Air Force General Hospital of the PLA, First Hospital of China Medical University, Chinese Academy of Medical Sciences
- Responsible party
- Sponsor-investigator, xjpfW, Xijing Hospital
- Investigators
- Gang Wang, Prof, Principal investigator, Dermatology Derpartment of Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948997
- Sponsor's protocol ID
- XijingH-PF-20150902
- Status last verified
- Mar 2021
- First submitted
- 10 May 2019
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Angiogenesis-related Pathways in the Development of Refractory Port Wine Stains
- ClinicalTrials.gov ID
- NCT03948997
- Acronym / sponsor ID
- XijingH-PF-20150902
- Conditions
- Port Wine Stain
- Keywords
- port wine stain, PI3K, vascular malformation,PDL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- xjpfWUniversity, hospital or other
- Collaborators
- Air Force General Hospital of the PLA, First Hospital of China Medical University, Chinese Academy of Medical Sciences
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 14 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Radiation: Pulsed dye laser (PDL)Patients with port wine stains receive PDL (1.5-10ms, 11-12.5J/cm2) with a treatment range of approximately 10*10cm2 |
| No treatment group | No intervention | –Patients with port wine stains have not been treated with PDL treatment |
Who may qualify
- Ages
- 1 month to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- Patients with severe infectious diseases;
- Heart disease patients;
- Epilepsy patient;
- Pregnant patient;
- Researchers believe that patients who are not suitable for this experiment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsed dye laser (PDL)Pulsed dye laser (PDL, 595nm) is effective for vasodilatory diseases, especially for the superficial to middle layers of the dermis | Radiation | Treatment group |
Primary outcome
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.
1 secondary outcome
Changes in the levels of cytokines in serum and skin tissues
Time frame: baseline (before treatment) and 1, 3, 7 days after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gang Wang, Prof principal investigator
Dermatology Derpartment of Xijing Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed dye laser (PDL) in people with Port Wine Stain, run by xjpfW.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exon mutation sequences and mutation frequencies (time frame: Baseline (before treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2021.