Port-Wine StainNCT01775722
Combined Bipolar Radiofrequency&Pulsed Dye Laser Treatment
A study testing Pulsed Dye Laser and Combined Bipolar Radiofrequency&Pulsed Dye Laser in people with Port-Wine Stain, run by University of California, Irvine at 1 site in United States.
Trial summary
Port wine stain Birthmark is a congenital, progressive vascular malformation of human skin. However, even though the pulsed dye laser is considered as the treatment of choice for Port wine stain Birthmark the degree of fading can remain variable and unpredictable after laser treatment. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Port-Wine Stain
- What is being tested?
- Pulsed Dye Laser and Combined Bipolar Radiofrequency&Pulsed Dye Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Aug 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Port Wine Stain suitable for comparison testing
- Age > 12 years of age; minor will be accompanied in the room by parents or guardians during laser treatment
- Apparent good health as documented by medical history
- Ability to understand and carry out subject instructions
Who cannot join
- History of photodermatoses or skin cancer
- Any therapy within the previous two months to the proposed port wine stain treatment sites
- Current participation in any other investigational drug or device evaluation
- Concurrent use of known photosensitizing drugs
- Inability to understand and carry out instructions
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: Combined Bipolar Radiofrequency and Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks
Port wine stain Birthmark is a congenital, progressive vascular malformation of human skin. However, even though the pulsed dye laser is considered as the treatment of choice for Port wine stain Birthmark the degree of fading can remain variable and unpredictable after laser treatment.
Read the detailed description
The researcher want to use the combination of radiofrequency electrical energy with pulsed dye laser light energy which can improve therapeutic outcome of Port wine stain Birthmark. This investigational device is essentially a combination of two commercially available systems cleared for marketing (K044351 and K052324) provided by Candela Laser Corporation.
- Conditions
- Port-Wine Stain
- Being tested
- Pulsed Dye Laser, Combined Bipolar Radiofrequency&Pulsed Dye Laser
- 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.
Pulsed Dye LaserDevice
Also called candela-Laser
port wine stain
Combined Bipolar Radiofrequency&Pulsed Dye LaserDevice
Combined Bipolar Radiofrequency\&Pulsed Dye Laser Treatment
| Study group | Role | What they receive |
|---|---|---|
| Pulsed Dye Laser | Other | port wine stain treatment using Pulse Dye Laser Receives: Device: Pulsed Dye Laser |
| Bipolar Radiofrequency&Pulsed Dye Laser | Experimental | Port wine stain using Combined Bipolar Radiofrequency\&Pulsed Dye Laser Receives: Device: Combined Bipolar Radiofrequency&Pulsed Dye Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Blanching of Port Wine Stain
Port Wine Stain blood volume fractions in the skin before (fB1), and 8 weeks after (fB2) treatment will be determined using the corresponding visual reflectance spectra measured at the treatment sites. The primary outcome, degree of blanching, B, is computed as B = (fB1-fB2)/fB1.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Candela Corporation, Beckman Laser Institute University of California Irvine
- Responsible party
- Principal investigator, Beckman Laser Institute and Medical Center, University of California, Irvine
- Investigators
- J. Stuart Nelson, M.D., Ph.D., Principal investigator, Beckman Laser Institute, UCI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01775722
- Sponsor's protocol ID
- 20129092
- Status last verified
- Oct 2022
- First submitted
- 14 Jan 2013
- Last updated
- 2 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Bipolar Radiofrequency and Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks
- ClinicalTrials.gov ID
- NCT01775722
- Acronym / sponsor ID
- 20129092
- Conditions
- Port-Wine Stain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Candela Corporation, Beckman Laser Institute University of California Irvine
- Study start
- Dec 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 25 Jan 2013 (estimated)
- Results
- Posted 9 Apr 2018
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 Birthmark is a congenital, progressive vascular malformation of human skin. However, even though the pulsed dye laser is considered as the treatment of choice for Port wine stain Birthmark the degree of fading can remain variable and unpredictable after laser treatment.
Detailed description
The researcher want to use the combination of radiofrequency electrical energy with pulsed dye laser light energy which can improve therapeutic outcome of Port wine stain Birthmark. This investigational device is essentially a combination of two commercially available systems cleared for marketing (K044351 and K052324) provided by Candela Laser Corporation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulsed Dye Laser | Other | Device: Pulsed Dye Laserport wine stain treatment using Pulse Dye Laser |
| Bipolar Radiofrequency&Pulsed Dye Laser | Experimental | Device: Combined Bipolar Radiofrequency&Pulsed Dye LaserPort wine stain using Combined Bipolar Radiofrequency\&Pulsed Dye Laser |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Port Wine Stain suitable for comparison testing
- Age > 12 years of age; minor will be accompanied in the room by parents or guardians during laser treatment
- Apparent good health as documented by medical history
- Ability to understand and carry out subject instructions
Key exclusion criteria (5 listed)
- History of photodermatoses or skin cancer
- Any therapy within the previous two months to the proposed port wine stain treatment sites
- Current participation in any other investigational drug or device evaluation
- Concurrent use of known photosensitizing drugs
- Inability to understand and carry out instructions
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 LaserAlso: candela-Laserport wine stain | Device | Pulsed Dye Laser |
| Combined Bipolar Radiofrequency&Pulsed Dye LaserCombined Bipolar Radiofrequency\&Pulsed Dye Laser Treatment | Device | Bipolar Radiofrequency&Pulsed Dye Laser |
Primary outcome
Percent Change in Blanching of Port Wine Stain
Time frame: 8 weeks
Port Wine Stain blood volume fractions in the skin before (fB1), and 8 weeks after (fB2) treatment will be determined using the corresponding visual reflectance spectra measured at the treatment sites. The primary outcome, degree of blanching, B, is computed as B = (fB1-fB2)/fB1.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
J. Stuart Nelson, M.D., Ph.D. 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?
A study testing Pulsed Dye Laser and Combined Bipolar Radiofrequency&Pulsed Dye Laser 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 4 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 2 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?
Yes. Results are posted in the registry (first posted 9 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change in Blanching of Port Wine Stain (time frame: 8 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 2 Nov 2022.