Port Wine StainPhase 1/2NCT00969397
Combined Use of Pulsed Dye Laser and Topical Antiangiogenic Agents for Treatment of Port Wine Stain Birthmarks
A Phase 1/2 study testing Topical Antiangiogenic and Pulsed Dye Laser in people with Port Wine Stain, run by University of California, Irvine.
Trial summary
The researcher want to improve port wine stain (PWS) therapeutic outcome in response to laser therapy. The researcher want to determine whether the combined use of pulsed dye laser (PDL) therapy and topical tacrolimus or pimecrolimus will improve PWS therapeutic outcome. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Port Wine Stain
- What is being tested?
- Topical Antiangiogenic and Pulsed Dye Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2009to Sep 2011
- Phase
- Phase 1/2
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 16 years of age and older
- Have PWS suitable for comparison testing as determined by the study doctor
Who cannot join
- Less than 16 years old
- Are pregnant
- Have skin cancer
- Currently taking immunosuppressive or steroids or photosensitizing drugs
- Current participation in any other investigational drug evaluation
- Concurrent use of known photosensitizing drugs
About this study
The researcher want to improve port wine stain (PWS) therapeutic outcome in response to laser therapy. The researcher want to determine whether the combined use of pulsed dye laser (PDL) therapy and topical tacrolimus or pimecrolimus will improve PWS therapeutic outcome.
Read the detailed description
Both topical agents inhibit nuclear factor of activated T-cells (NFAT) which blocks the calcineurin/NFAT pathway inhibiting endothelial cell proliferation and angiogenesis, which could be very useful in preventing PWS recanalization.
The combined use of PDL to induce PWS blood vessel injury, and topical antiangiogenic agents to prevent PWS blood vessel angiogenesis and recanalization after laser therapy, will improve PWS lesion blanching.
- Conditions
- Port Wine Stain
- Being tested
- Topical Antiangiogenic, Pulsed Dye Laser
- Keywords
- Birthmark, PWS
- 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.
Topical AntiangiogenicDrug
Topical Antiangiogenic
Pulsed Dye LaserDevice
Pulsed Dye Laser
| Study group | Role | What they receive |
|---|---|---|
| Topical Antiangiogenic | Experimental | Topical Antiangiogenic Agents Receives: Drug: Topical Antiangiogenic |
| Pulsed Dye Laser | Experimental | Pulsed Dye Laser Receives: Device: Pulsed Dye Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improve PWS lesion blanching.
Measured: 8 weeks
Secondary outcomes (1)
To determine whether the combined use of pulsed dye laser (PDL) therapy and topical agent will improve PWS outcome.
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 posted1 Sep 2009 (estimated)
- Study startNov 2009
- Primary completionSep 2011
- Study completionSep 2011
Why it stopped: We have decided not to pursue the study
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 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, M.D,PhD, Principal investigator, Beckman Laser Institute University of California Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00969397
- Sponsor's protocol ID
- 20097069
- Status last verified
- Oct 2022
- First submitted
- 31 Aug 2009
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
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
- Combined Use of Pulsed Dye Laser and Topical Antiangiogenic Agents for Treatment of Port Wine Stain Birthmarks
- ClinicalTrials.gov ID
- NCT00969397
- Acronym / sponsor ID
- 20097069
- Conditions
- Port Wine Stain
- Keywords
- Birthmark, PWS
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We have decided not to pursue the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Study start
- Nov 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 1 Sep 2009 (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 researcher want to improve port wine stain (PWS) therapeutic outcome in response to laser therapy. The researcher want to determine whether the combined use of pulsed dye laser (PDL) therapy and topical tacrolimus or pimecrolimus will improve PWS therapeutic outcome.
Detailed description
Both topical agents inhibit nuclear factor of activated T-cells (NFAT) which blocks the calcineurin/NFAT pathway inhibiting endothelial cell proliferation and angiogenesis, which could be very useful in preventing PWS recanalization.
The combined use of PDL to induce PWS blood vessel injury, and topical antiangiogenic agents to prevent PWS blood vessel angiogenesis and recanalization after laser therapy, will improve PWS lesion blanching.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical Antiangiogenic | Experimental | Drug: Topical AntiangiogenicTopical Antiangiogenic Agents |
| Pulsed Dye Laser | Experimental | Device: Pulsed Dye LaserPulsed Dye Laser |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 16 years of age and older
- Have PWS suitable for comparison testing as determined by the study doctor
Key exclusion criteria (6 listed)
- Less than 16 years old
- Are pregnant
- Have skin cancer
- Currently taking immunosuppressive or steroids or photosensitizing drugs
- Current participation in any other investigational drug evaluation
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 |
|---|---|---|
| Topical AntiangiogenicTopical Antiangiogenic | Drug | Topical Antiangiogenic |
| Pulsed Dye LaserPulsed Dye Laser | Device | Pulsed Dye Laser |
Primary outcome
Improve PWS lesion blanching.
Time frame: 8 weeks
1 secondary outcome
To determine whether the combined use of pulsed dye laser (PDL) therapy and topical agent will improve PWS outcome.
Time frame: 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
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, M.D,PhD principal investigator
Beckman Laser Institute University of California Irvine
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Topical Antiangiogenic and Pulsed Dye Laser in people with Port Wine Stain, run by University of California, Irvine.
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 2 inclusion and 6 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: withdrawn, 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.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Improve PWS lesion blanching. (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 1 Nov 2022.