Port-Wine StainNCT02051101
Pathogenic Mechanisms of Port Wine Stain and Repository of Port Wine Stain Biopsy Samples
A study testing Biopsy sample from Port Wine Stain Birthmark in people with Port-Wine Stain, run by University of California, Irvine at 1 site in United States.
Trial summary
The purpose of this study is to investigate the pathogenic mechanisms of Port Wine Stain, collect biopsy samples and blood samples to characterize exosomes and metabolites from Port Wine Stain. Read more about this study
- Who is it for?
- Ages 1 day and olderHealthy volunteers can take part
- Conditions the study is for
- Port-Wine Stain
- What is being tested?
- Biopsy sample from Port Wine Stain Birthmark
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2013to 11 Jan 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 day and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Male or female of all ages.
- Not pregnant.
- Has diagnosis of port wine stain on the arms, legs, chest, bac.
- Ability to understand and carry out subject instructions.
- Subject willing to have skin biopsies on port wine stain and normal skin areas.
Who cannot join
- Pregnant women.
- Port Wine Stain on the face.
- History of skin cancer.
- Current participation in an investigational drug evaluation
- Concurrent use of known photosensitizing drugs.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the pathogenic mechanisms of Port Wine Stain, collect biopsy samples and blood samples to characterize exosomes and metabolites from Port Wine Stain.
Read the detailed description
The researcher can detect the defects in nervous system innervation to cutaneous blood vessels contribute to the pathogenesis of Port Wine Stain . Unveiling the pathogenic mechanisms of PWS is crucial to the design of new therapeutic strategies and can use the results to improve current PWS therapeutic outcomes.
- Conditions
- Port-Wine Stain
- Being tested
- Biopsy sample from Port Wine Stain Birthmark
- Medical subject headings
- Port-Wine Stain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy sample from Port Wine Stain BirthmarkOther
Biopsy sample from Port Wine Stain Birthmark
| Study group | Role | What they receive |
|---|---|---|
| Port Wine Stain Birthmark | Other | Biopsy sample from Port Wine Stain Birthmark Receives: Other: Biopsy sample from Port Wine Stain Birthmark |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of Port Wine Stain Birthmark tissue sample
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study start23 Apr 2013
- Primary completion11 Jan 2019
- Study completion11 Jan 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.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Responsible party
- Principal investigator, Beckman Laser Institute and Medical Center, University of California, Irvine
- Investigators
- John s Nelson, MD, Study director, Beckman Laser Institute, UCIWinbin Tan, PhD, Principal investigator, Beckman Laser Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02051101
- Sponsor's protocol ID
- 20139396
- Status last verified
- Oct 2022
- First submitted
- 6 Nov 2013
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathogenic Mechanisms of Port Wine Stain and Repository of Port Wine Stain Biopsy Samples
- ClinicalTrials.gov ID
- NCT02051101
- Acronym / sponsor ID
- 20139396
- Conditions
- Port-Wine Stain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Study start
- 23 Apr 2013 (actual)
- Primary completion
- 11 Jan 2019 (actual)
- Study completion
- 11 Jan 2019 (actual)
- First posted
- 31 Jan 2014 (estimated)
- 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.
The purpose of this study is to investigate the pathogenic mechanisms of Port Wine Stain, collect biopsy samples and blood samples to characterize exosomes and metabolites from Port Wine Stain.
Detailed description
The researcher can detect the defects in nervous system innervation to cutaneous blood vessels contribute to the pathogenesis of Port Wine Stain . Unveiling the pathogenic mechanisms of PWS is crucial to the design of new therapeutic strategies and can use the results to improve current PWS therapeutic outcomes.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Port Wine Stain Birthmark | Other | Other: Biopsy sample from Port Wine Stain BirthmarkBiopsy sample from Port Wine Stain Birthmark |
Who may qualify
- Ages
- 1 day and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female of all ages.
- Not pregnant.
- Has diagnosis of port wine stain on the arms, legs, chest, bac.
- Ability to understand and carry out subject instructions.
- Subject willing to have skin biopsies on port wine stain and normal skin areas.
Key exclusion criteria (5 listed)
- Pregnant women.
- Port Wine Stain on the face.
- History of skin cancer.
- Current participation in an investigational drug evaluation
- Concurrent use of known photosensitizing drugs.
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 |
|---|---|---|
| Biopsy sample from Port Wine Stain BirthmarkBiopsy sample from Port Wine Stain Birthmark | Other | Port Wine Stain Birthmark |
Primary outcome
Characterization of Port Wine Stain Birthmark tissue sample
Time frame: up to 4 weeks
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 1 Nov 2022.
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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.
John s Nelson, MD study director
Beckman Laser Institute, UCI
Winbin Tan, PhD principal investigator
Beckman Laser Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy sample from Port Wine Stain Birthmark in people with Port-Wine Stain, run by University of California, Irvine at 1 site in United States.
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 5 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 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Characterization of Port Wine Stain Birthmark tissue sample (time frame: up to 4 weeks). 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 1 Nov 2022.