Port-wine StainNCT01774552
Evaluate the Port-wine Stain Birthmark Treatment Before and After Pulsed Dye Laser Treatment
An observational study of Port-wine Stain, run by University of California, Irvine at 1 site in United States.
Trial summary
Port-wine stain is a congenital, progressive vascular malformation of human skin involving post-capillary venules that occurs in an estimated 0.3% of children and can alter personality development and psychological in children. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Port-wine Stain
- What is being tested?
- Photo Acoustic Microscopy and Optical Coherence tomography
- Type of treatment
- Medical device
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to 28 Nov 2017
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Study population will be selected from Beckman Laser Medical Clinic, UCI
Who may be able to join
- All age with diagnosis of Port-wine stain
Who cannot join
- No diagnosis of Port-wine stain
Trial locations and contacts
1 site in 1 country.
United States1 site
Beckman Laser Institute Medical Clinic
Irvine, California, 92612
About this study
Official title: A Pilot Study of Photo Acoustic Microscopy and Optical Coherence Tomography Imaging Technologies to Evaluate the Port-wine Stain Birthmark Treatment Before and After Pulsed Dye Laser Treatment.
Port-wine stain is a congenital, progressive vascular malformation of human skin involving post-capillary venules that occurs in an estimated 0.3% of children and can alter personality development and psychological in children.
Read the detailed description
The researchers at University of California, Irvine and Washington University in Saint Louis are collaborating in this project and developes new multiple imaging devices call photoacoustic microscopy and optical coherence tomography imaging technologies can be use to evaluate the response of port-wine stain from Pulse Dye Laser treatment.
- Conditions
- Port-wine Stain
- Being tested
- Photo Acoustic Microscopy and Optical Coherence tomography
- 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.
Photo Acoustic Microscopy and Optical Coherence tomographyDevice
Photo Acoustic Microscopy and Optical Coherence tomography
| Study group | Role | What they receive |
|---|---|---|
| Port-wine stain | Photo Acoustic Microscopy and Optical Coherence tomography Receives: Device: Photo Acoustic Microscopy and Optical Coherence tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the port-wine stain birthmark
pulsed dye laser treatment
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2013 (estimated)
- Study startDec 2012
- Primary completion28 Nov 2017
- Study completion28 Nov 2017
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 4 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
- Wancun Jia, PhD, Principal investigator, Beckman Laser Institute, UCI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01774552
- Sponsor's protocol ID
- 20129094
- Status last verified
- Oct 2022
- First submitted
- 22 Jan 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
- A Pilot Study of Photo Acoustic Microscopy and Optical Coherence Tomography Imaging Technologies to Evaluate the Port-wine Stain Birthmark Treatment Before and After Pulsed Dye Laser Treatment.
- ClinicalTrials.gov ID
- NCT01774552
- Acronym / sponsor ID
- 20129094
- Conditions
- Port-wine Stain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Study start
- Dec 2012
- Primary completion
- 28 Nov 2017 (actual)
- Study completion
- 28 Nov 2017 (actual)
- First posted
- 24 Jan 2013 (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.
Port-wine stain is a congenital, progressive vascular malformation of human skin involving post-capillary venules that occurs in an estimated 0.3% of children and can alter personality development and psychological in children.
Detailed description
The researchers at University of California, Irvine and Washington University in Saint Louis are collaborating in this project and developes new multiple imaging devices call photoacoustic microscopy and optical coherence tomography imaging technologies can be use to evaluate the response of port-wine stain from Pulse Dye Laser treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Port-wine stain | – | Device: Photo Acoustic Microscopy and Optical Coherence tomographyPhoto Acoustic Microscopy and Optical Coherence tomography |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study population will be selected from Beckman Laser Medical Clinic, UCI
Key inclusion criteria (1 listed)
- All age with diagnosis of Port-wine stain
Key exclusion criteria (1 listed)
- No diagnosis of Port-wine stain
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 |
|---|---|---|
| Photo Acoustic Microscopy and Optical Coherence tomographyPhoto Acoustic Microscopy and Optical Coherence tomography | Device | Port-wine stain |
Primary outcome
evaluate the port-wine stain birthmark
Time frame: up to 12 months
pulsed dye laser 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 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.
Wancun Jia, PhD principal investigator
Beckman Laser Institute, UCI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 1 inclusion and 1 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?
evaluate the port-wine stain birthmark (time frame: up to 12 months). 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.